Trial Outcomes & Findings for Bevacizumab, Radiation Therapy, and Combination Chemotherapy in Treating Patients Who Are Undergoing Surgery for Locally Advanced Nonmetastatic Rectal Cancer (NCT NCT00321685)
NCT ID: NCT00321685
Last Updated: 2019-03-27
Results Overview
Pathologic complete response to preoperative therapy was determined at the time of surgical resection. Pathologic complete response (pCR) is defined as no evidence of invasive cells on pathologic examination of the primary rectal cancer (or tissue from the area where the tumor had been if there is a complete clinical response). Pathologic complete response rate is calculated as number of patients achieving pathologic complete response divided by all eligible and treated patients
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
57 participants
Primary outcome timeframe
Assessed at surgery time
Results posted on
2019-03-27
Participant Flow
This study was activated on July 25, 2006 and terminated on May 26, 2010 with a final accrual of 57 patients from 11 participating sites.
Participant milestones
| Measure |
Arm I
Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.
Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.
Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.
Postoperative chemotherapy: Approximately 4-12 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab.
radiation therapy: Patients undergo 3-dimensional conformal radiation therapy once daily 5 days
|
|---|---|
|
Overall Study
STARTED
|
57
|
|
Overall Study
Eligible
|
55
|
|
Overall Study
Started Protocol Therapy
|
55
|
|
Overall Study
Eligible and Treated
|
53
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
39
|
Reasons for withdrawal
| Measure |
Arm I
Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.
Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.
Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.
Postoperative chemotherapy: Approximately 4-12 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab.
radiation therapy: Patients undergo 3-dimensional conformal radiation therapy once daily 5 days
|
|---|---|
|
Overall Study
Adverse Event
|
18
|
|
Overall Study
Death
|
2
|
|
Overall Study
Withdrawal by Subject
|
8
|
|
Overall Study
Alternative therapy
|
1
|
|
Overall Study
Complicating disese
|
1
|
|
Overall Study
Other
|
5
|
|
Overall Study
Not start protocol therapy
|
2
|
|
Overall Study
Ineligible
|
2
|
Baseline Characteristics
Bevacizumab, Radiation Therapy, and Combination Chemotherapy in Treating Patients Who Are Undergoing Surgery for Locally Advanced Nonmetastatic Rectal Cancer
Baseline characteristics by cohort
| Measure |
Arm I
n=53 Participants
Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.
Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.
Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.
Postoperative chemotherapy: Approximately 4-8 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab.
|
|---|---|
|
Age, Continuous
|
54 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=99 Participants
|
|
Clinical T stage
T3
|
49 participants
n=99 Participants
|
|
Clinical T stage
T4
|
4 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Assessed at surgery timePopulation: Eligible and treated patients
Pathologic complete response to preoperative therapy was determined at the time of surgical resection. Pathologic complete response (pCR) is defined as no evidence of invasive cells on pathologic examination of the primary rectal cancer (or tissue from the area where the tumor had been if there is a complete clinical response). Pathologic complete response rate is calculated as number of patients achieving pathologic complete response divided by all eligible and treated patients
Outcome measures
| Measure |
Arm I
n=53 Participants
Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.
Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.
Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.
Postoperative chemotherapy: Approximately 4-12 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab.
|
|---|---|
|
Pathologic Complete Response Rate
|
17 percentage of participants
Interval 7.0 to 32.0
|
SECONDARY outcome
Timeframe: Assessed at surgery timePopulation: eligible and treated patients with T3 rectal cancers
Resection rate is defined as number of patients with T3 rectal cancer who underwent curative surgical resection among all eligible and treated patients with T3 rectal cancers
Outcome measures
| Measure |
Arm I
n=49 Participants
Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.
Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.
Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.
Postoperative chemotherapy: Approximately 4-12 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab.
|
|---|---|
|
Resection Rate for T3 Rectal Cancers
|
92 percentage of participants
Interval 82.0 to 97.0
|
SECONDARY outcome
Timeframe: Assessed at surgery timePopulation: eligible and treated patients with T4 rectal cancers
Resection rate is defined as number of patients with T4 rectal cancer who underwent curative surgical resection among all eligible and treated patients with T4 rectal cancers
Outcome measures
| Measure |
Arm I
n=4 Participants
Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.
Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.
Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.
Postoperative chemotherapy: Approximately 4-12 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab.
|
|---|---|
|
Resection Rate for T4 Rectal Cancers
|
75 percentage of participants
Interval 25.0 to 99.0
|
SECONDARY outcome
Timeframe: survival follow-up began after post-operative chemotherapy, assessed every 3 months for patients 3-5 years from registration, every 6 months for patients 5-10 years from registration and every 12 months for patients 10 years from registrationPopulation: Eligible and treated patients
Overall survival is defined as time from registration to death from any cause. 5-year overall survival rate is estimated using Kaplan-Meier method.
Outcome measures
| Measure |
Arm I
n=53 Participants
Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.
Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.
Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.
Postoperative chemotherapy: Approximately 4-12 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab.
|
|---|---|
|
5-year Overall Survival Rate
|
80 percentage of participants
Interval 67.0 to 92.0
|
SECONDARY outcome
Timeframe: recurrence follow-up began after post-operative chemotherapy, assessed every 3 months for patients 3-5 years from registration, every 6 months for patients 5-10 years from registration and every 12 months for patients 10 years from registrationPopulation: Eligible and treated patients who underwent surgery after neoadjuvant therapy
Recurrence free survival is defined as time from surgery to disease recurrence or death without recurrence (whichever occurred first) among resected patients. 5-year recurrence-free survival rate is estimated using Kaplan-Meier method, with 90% confidence interval calculated using Greenwood's formula.
Outcome measures
| Measure |
Arm I
n=48 Participants
Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.
Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.
Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.
Postoperative chemotherapy: Approximately 4-12 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab.
|
|---|---|
|
5-year Recurrence-free Survival Rate
|
81 percentage of participants
Interval 68.0 to 94.0
|
Adverse Events
Arm I
Serious events: 39 serious events
Other events: 53 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I
n=55 participants at risk
Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.
Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.
Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.
Postoperative chemotherapy: Approximately 4-8 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab.
|
|---|---|
|
Immune system disorders
Allergic reaction
|
1.8%
1/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Blood and lymphatic system disorders
Anemia
|
9.1%
5/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Investigations
Leukocytes decreased
|
14.5%
8/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Investigations
Lymphopenia
|
14.5%
8/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Investigations
Neutrophils decreased
|
18.2%
10/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Investigations
Platelets decreased
|
5.5%
3/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
General disorders
Fatigue
|
16.4%
9/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
General disorders
Hypothermia
|
1.8%
1/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Investigations
Weight loss
|
3.6%
2/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Blood and lymphatic system disorders
DIC
|
1.8%
1/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Investigations
Coagulation-other
|
1.8%
1/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
3.6%
2/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Injury, poisoning and procedural complications
Chemoradiation dermatitis
|
1.8%
1/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Injury, poisoning and procedural complications
Wound - non-infectious
|
3.6%
2/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
1.8%
1/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
General disorders
Death NOS
|
1.8%
1/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Metabolism and nutrition disorders
Anorexia
|
3.6%
2/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Gastrointestinal disorders
Constipation
|
1.8%
1/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
5/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
12.7%
7/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Gastrointestinal disorders
Distention/bloating, abdominal
|
1.8%
1/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Gastrointestinal disorders
Enteritis
|
1.8%
1/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Gastrointestinal disorders
Fistula, Rectum
|
1.8%
1/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Gastrointestinal disorders
Ileus
|
3.6%
2/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Gastrointestinal disorders
Nausea
|
5.5%
3/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Gastrointestinal disorders
Proctitis
|
1.8%
1/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Gastrointestinal disorders
Vomiting
|
5.5%
3/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Nervous system disorders
CNS, hemorrhage
|
1.8%
1/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Gastrointestinal disorders
Oral cavity, hemorrhage
|
1.8%
1/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Infections and infestations
Infection Gr0-2 neut, anal/perianl
|
1.8%
1/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Infections and infestations
Infection Gr0-2 neut, muscle
|
1.8%
1/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Infections and infestations
Infection Gr0-2 neut, pelvis NOS
|
1.8%
1/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Infections and infestations
Infection Gr0-2 neut, rectum
|
1.8%
1/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Infections and infestations
Infection Gr0-2 neut, wound
|
3.6%
2/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Infections and infestations
Infection w/ unk ANC anal/perianal
|
3.6%
2/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Infections and infestations
Infection w/ unk ANC wound
|
1.8%
1/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Metabolism and nutrition disorders
Acidosis
|
1.8%
1/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
3.6%
2/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Investigations
Alkaline phosphatase increased
|
1.8%
1/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Investigations
Aspartate aminotransferase increased
|
1.8%
1/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.8%
1/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.6%
2/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
1.8%
1/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.6%
2/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.8%
1/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Investigations
Metabolic/Laboratory-other
|
1.8%
1/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Nervous system disorders
Neuropathy-motor
|
1.8%
1/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Nervous system disorders
Neuropathy-sensory
|
9.1%
5/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Gastrointestinal disorders
Abdomen, pain
|
9.1%
5/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Musculoskeletal and connective tissue disorders
Bone, pain
|
1.8%
1/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Gastrointestinal disorders
Intestine, pain
|
1.8%
1/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Reproductive system and breast disorders
Perineum, pain
|
1.8%
1/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Gastrointestinal disorders
Rectum, pain
|
16.4%
9/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
General disorders
Pain-other
|
1.8%
1/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.8%
1/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Renal and urinary disorders
Incontinence urinary
|
1.8%
1/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Renal and urinary disorders
Renal failure
|
1.8%
1/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Renal and urinary disorders
Urinary retention
|
1.8%
1/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Reproductive system and breast disorders
Erectile impotence
|
1.8%
1/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
3.6%
2/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
Other adverse events
| Measure |
Arm I
n=55 participants at risk
Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.
Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.
Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.
Postoperative chemotherapy: Approximately 4-8 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
60.0%
33/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Investigations
Leukocytes decreased
|
41.8%
23/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Investigations
Lymphopenia
|
12.7%
7/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Investigations
Neutrophils decreased
|
30.9%
17/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Investigations
Platelets decreased
|
40.0%
22/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Vascular disorders
Hypotension
|
7.3%
4/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
General disorders
Fatigue
|
56.4%
31/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
General disorders
Fever w/o neutropenia
|
9.1%
5/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Psychiatric disorders
Insomnia
|
9.1%
5/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
General disorders
Rigors/chills
|
5.5%
3/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
7.3%
4/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Investigations
Weight loss
|
30.9%
17/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.5%
3/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.3%
4/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
5.5%
3/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
12.7%
7/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Skin and subcutaneous tissue disorders
Hand-foot reaction
|
5.5%
3/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Injury, poisoning and procedural complications
Wound - non-infectious
|
10.9%
6/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Metabolism and nutrition disorders
Anorexia
|
30.9%
17/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Gastrointestinal disorders
Constipation
|
16.4%
9/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
5/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
49.1%
27/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Gastrointestinal disorders
Dry mouth
|
5.5%
3/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.1%
5/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Gastrointestinal disorders
Incontinence, anal
|
5.5%
3/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral cavity
|
12.7%
7/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Gastrointestinal disorders
Nausea
|
41.8%
23/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Gastrointestinal disorders
Proctitis
|
9.1%
5/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Nervous system disorders
Taste disturbance
|
7.3%
4/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Gastrointestinal disorders
Vomiting
|
23.6%
13/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Gastrointestinal disorders
Rectum, hemorrhage
|
7.3%
4/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Renal and urinary disorders
Urinary hemorrhage NOS
|
5.5%
3/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Respiratory, thoracic and mediastinal disorders
Nose, hemorrhage
|
5.5%
3/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
7.3%
4/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Investigations
Alkaline phosphatase increased
|
5.5%
3/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Investigations
Alanine aminotransferase increased
|
9.1%
5/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
11/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.7%
7/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.1%
5/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.9%
6/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.3%
4/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Investigations
Metabolic/Laboratory-other
|
5.5%
3/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Nervous system disorders
Dizziness
|
5.5%
3/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Psychiatric disorders
Depression
|
5.5%
3/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Nervous system disorders
Neuropathy-sensory
|
50.9%
28/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Gastrointestinal disorders
Abdomen, pain
|
16.4%
9/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Musculoskeletal and connective tissue disorders
Back, pain
|
5.5%
3/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Nervous system disorders
Head/headache
|
9.1%
5/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Gastrointestinal disorders
Rectum, pain
|
25.5%
14/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.1%
5/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
5.5%
3/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
10.9%
6/55 • Assessed at the completion of Pre-Operative Chemoradiation, at the end of every cycle during PostOperative Chemotherapy, and at 30 days after the end of treatment
Prior to diagnosis of progression/relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported were collected using the Long-term follow up form.
|
Additional Information
Study Statistician
ECOG-ACRIN Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60