Trial Outcomes & Findings for Cetuximab, Chemotherapy, and Radiation Therapy for Operable Stage III or IV Head and Neck Cancer (NCT NCT00089297)
NCT ID: NCT00089297
Last Updated: 2023-06-29
Results Overview
Event-free survival rate at 1 year was defined as the proportion of patients who did not have disease progression, primary site surgery, or death after being followed for 1 year.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
74 participants
Primary outcome timeframe
Assessed at 1 year.
Results posted on
2023-06-29
Participant Flow
The study was activated on December 15, 2004, accrued its first patient on January 6, 2005, and was closed to accrual on February 6, 2006 after accruing 74 patients.
Participant milestones
| Measure |
Cetuximab/Paclitaxel/Carboplatin
Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.
Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).
Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.
Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks.
|
|---|---|
|
Overall Study
STARTED
|
74
|
|
Overall Study
Treated
|
70
|
|
Overall Study
Eligible
|
63
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
38
|
Reasons for withdrawal
| Measure |
Cetuximab/Paclitaxel/Carboplatin
Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.
Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).
Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.
Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks.
|
|---|---|
|
Overall Study
Adverse Event
|
9
|
|
Overall Study
Death
|
1
|
|
Overall Study
Withdrawal by Subject
|
12
|
|
Overall Study
Disease progression
|
2
|
|
Overall Study
Ineligible
|
11
|
|
Overall Study
Secondary malignancy
|
1
|
|
Overall Study
IRB approval not ready
|
1
|
|
Overall Study
Non-compliance
|
1
|
Baseline Characteristics
Cetuximab, Chemotherapy, and Radiation Therapy for Operable Stage III or IV Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Cetuximab/Paclitaxel/Carboplatin
n=63 Participants
Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.
Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).
Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.
Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks.
|
|---|---|
|
Age, Continuous
|
57 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Assessed at 1 year.Population: Only eligible patients are included in the analysis.
Event-free survival rate at 1 year was defined as the proportion of patients who did not have disease progression, primary site surgery, or death after being followed for 1 year.
Outcome measures
| Measure |
Cetuximab/Paclitaxel/Carboplatin
n=63 Participants
Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.
Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).
Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.
Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks.
|
|---|---|
|
Event-free Survival Rate at 1 Year
|
0.79 proportion of patients
Interval 0.69 to 0.89
|
SECONDARY outcome
Timeframe: Assessed at weeks 7, 14, 18, 20, and then every every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entryPopulation: Only eligible patients are included in this analysis.
Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= \>=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR.
Outcome measures
| Measure |
Cetuximab/Paclitaxel/Carboplatin
n=63 Participants
Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.
Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).
Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.
Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks.
|
|---|---|
|
Proportion of Patients With Objective Response by RECIST
|
0.86 proportion of patients
Interval 0.75 to 0.93
|
SECONDARY outcome
Timeframe: Assessed at weeks 7, 14, 18, 20, and then every every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entryPopulation: Only eligible patients are included in the analysis.
Progression-free survival was defined as the time from registration to documented progression or death without progression. Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions.
Outcome measures
| Measure |
Cetuximab/Paclitaxel/Carboplatin
n=63 Participants
Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.
Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).
Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.
Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks.
|
|---|---|
|
Progression-free Survival
|
47.5 Months
Interval 32.6 to
The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
|
SECONDARY outcome
Timeframe: Weekly during treatment, and then every every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entryPopulation: Only eligible patients are included in the analysis.
Overall survival is defined as the time from registration to death of any causes.
Outcome measures
| Measure |
Cetuximab/Paclitaxel/Carboplatin
n=63 Participants
Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.
Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).
Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.
Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks.
|
|---|---|
|
Overall Survival
|
49.4 Months
Interval 47.5 to
The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
|
Adverse Events
Cetuximab/Paclitaxel/Carboplatin
Serious events: 64 serious events
Other events: 70 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cetuximab/Paclitaxel/Carboplatin
n=70 participants at risk
Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.
Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).
Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.
Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks.
|
|---|---|
|
Immune system disorders
Allergic reaction
|
4.3%
3/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
1.4%
1/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Leukocytes, decreased
|
40.0%
28/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Lymphopenia
|
5.7%
4/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Neutrophils, decreased
|
44.3%
31/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Fatigue
|
8.6%
6/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Weight loss
|
10.0%
7/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Injury, poisoning and procedural complications
Burn
|
1.4%
1/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
4.3%
3/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
11.4%
8/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Injury, poisoning and procedural complications
Radiation dermatitis
|
22.9%
16/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
18.6%
13/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.0%
7/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
4.3%
3/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
5.7%
4/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
28.6%
20/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Esophagitis
|
1.4%
1/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
2.9%
2/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral cavity
|
50.0%
35/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Muco/stomatitis (symptom) pharynx
|
1.4%
1/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Nausea
|
2.9%
2/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
2/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.9%
2/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection Gr0-2 neut, bladder
|
1.4%
1/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection Gr0-2 neut, catheter
|
2.9%
2/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection Gr0-2 neut, colon
|
2.9%
2/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection Gr0-2 neut, foreign body
|
2.9%
2/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection Gr0-2 neut, mucosa
|
2.9%
2/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection Gr0-2 neut, oral cavity
|
2.9%
2/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection Gr0-2 neut, pharynx
|
2.9%
2/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection Gr0-2 neut, skin
|
1.4%
1/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection Gr0-2 neut, urinary tract
|
1.4%
1/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection w/ unk ANC wound
|
1.4%
1/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Blood bilirubin increased
|
2.9%
2/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.4%
1/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Creatinine, increased
|
1.4%
1/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.4%
1/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
4.3%
3/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
4.3%
3/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.4%
1/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.9%
2/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.4%
1/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Neuropathy-motor
|
1.4%
1/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Esophagus, pain
|
1.4%
1/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Oral cavity, pain
|
5.7%
4/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Throat/pharynx/larynx, pain
|
2.9%
2/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
1.4%
1/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
1.4%
1/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.9%
2/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Obstruction, airway-larynx
|
1.4%
1/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
4.3%
3/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
1.4%
1/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
Other adverse events
| Measure |
Cetuximab/Paclitaxel/Carboplatin
n=70 participants at risk
Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.
Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).
Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.
Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
88.6%
62/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Leukocytes, decreased
|
87.1%
61/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Lymphopenia
|
7.1%
5/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Neutrophils, decreased
|
50.0%
35/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Platelets, decreased
|
27.1%
19/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Vascular disorders
Hypotension
|
10.0%
7/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Fatigue
|
78.6%
55/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Fever w/o neutropenia
|
18.6%
13/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Psychiatric disorders
Insomnia
|
10.0%
7/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Weight loss
|
60.0%
42/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
7.1%
5/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
22.9%
16/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
64.3%
45/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
11.4%
8/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
15.7%
11/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
34.3%
24/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
91.4%
64/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Injury, poisoning and procedural complications
Radiation dermatitis
|
62.9%
44/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
40.0%
28/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Constipation
|
37.1%
26/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.0%
7/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
22.9%
16/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
71.4%
50/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
68.6%
48/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
7/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral cavity
|
72.9%
51/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Nausea
|
44.3%
31/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Taste disturbance
|
30.0%
21/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Vomiting
|
27.1%
19/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nose, hemorrhage
|
5.7%
4/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection Gr0-2 neut, oral cavity
|
8.6%
6/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection Gr0-2 neut, ungual
|
5.7%
4/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Edema limb
|
5.7%
4/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
11.4%
8/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Alanine aminotransferase increased
|
51.4%
36/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
44.3%
31/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Blood bilirubin increased
|
12.9%
9/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.0%
7/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Creatinine, increased
|
5.7%
4/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.9%
9/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
21.4%
15/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.9%
9/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.7%
4/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
8.6%
6/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Dizziness
|
11.4%
8/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Psychiatric disorders
Depression
|
20.0%
14/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Neuropathy-sensory
|
34.3%
24/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Eye disorders
Dry eye syndrome
|
5.7%
4/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Eye disorders
Ocular surface disease
|
5.7%
4/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Eye disorders
Vision-blurred
|
5.7%
4/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Head/headache
|
15.7%
11/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
17.1%
12/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
17.1%
12/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck, pain
|
5.7%
4/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Oral cavity, pain
|
14.3%
10/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Throat/pharynx/larynx, pain
|
10.0%
7/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
7.1%
5/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.9%
9/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
12.9%
9/70 • Assessed weekly while on treatment and for 30 days after the end of treatment.
|
Additional Information
Study Statistician
ECOG Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place