Trial Outcomes & Findings for Chemotherapy Followed by Surgery, Chemotherapy, and Radiation Therapy in Treating Patients With Locally Advanced Head And Neck Cancer (NCT NCT00544414)
NCT ID: NCT00544414
Last Updated: 2025-02-19
Results Overview
Complete response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. Partial response (PR): Greater than or equal 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No new lesions. All measurable and evaluable lesions and sites must be assessed using the same techniques as baseline. Overall Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
30 days after last course of treatment
Results posted on
2025-02-19
Participant Flow
Participant milestones
| Measure |
Treatment
Patients receive neoadjuvant induction chemotherapy comprising docetaxel IV over 1 hour on day 1 and cisplatin IV, leucovorin IV, and fluorouracil IV over 24 hours on days 1-4. Induction chemotherapy repeats every 28 days for 3 courses.
Patients with partial response at the primary site may undergo radical or functional resection of the primary tumor within 3 weeks of completion of neoadjuvant therapy.
Beginning within 4 weeks of completion of neoadjuvant therapy, patients with persistent disease or complete response after chemotherapy at the primary or neck then undergo radiotherapy 5 days a week for 7 weeks and receive gemcitabine hydrochloride IV over 30 minutes and cisplatin IV over 60 minutes on day 1 of each week of radiotherapy.
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chemotherapy Followed by Surgery, Chemotherapy, and Radiation Therapy in Treating Patients With Locally Advanced Head And Neck Cancer
Baseline characteristics by cohort
| Measure |
Treatment
n=31 Participants
Patients receive neoadjuvant induction chemotherapy comprising docetaxel IV over 1 hour on day 1 and cisplatin IV, leucovorin IV, and fluorouracil IV over 24 hours on days 1-4. Induction chemotherapy repeats every 28 days for 3 courses.
Patients with partial response at the primary site may undergo radical or functional resection of the primary tumor within 3 weeks of completion of neoadjuvant therapy.
Beginning within 4 weeks of completion of neoadjuvant therapy, patients with persistent disease or complete response after chemotherapy at the primary or neck then undergo radiotherapy 5 days a week for 7 weeks and receive gemcitabine hydrochloride IV over 30 minutes and cisplatin IV over 60 minutes on day 1 of each week of radiotherapy.
|
|---|---|
|
Age, Continuous
|
62 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
African American
|
3 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
6 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
22 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 30 days after last course of treatmentComplete response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. Partial response (PR): Greater than or equal 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No new lesions. All measurable and evaluable lesions and sites must be assessed using the same techniques as baseline. Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Treatment
n=31 Participants
Patients receive neoadjuvant induction chemotherapy comprising docetaxel IV over 1 hour on day 1 and cisplatin IV, leucovorin IV, and fluorouracil IV over 24 hours on days 1-4. Induction chemotherapy repeats every 28 days for 3 courses.
Patients with partial response at the primary site may undergo radical or functional resection of the primary tumor within 3 weeks of completion of neoadjuvant therapy.
Beginning within 4 weeks of completion of neoadjuvant therapy, patients with persistent disease or complete response after chemotherapy at the primary or neck then undergo radiotherapy 5 days a week for 7 weeks and receive gemcitabine hydrochloride IV over 30 minutes and cisplatin IV over 60 minutes on day 1 of each week of radiotherapy.
|
|---|---|
|
Overall Response
|
28 Participants
|
PRIMARY outcome
Timeframe: From date of initial treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 171 monthsEstimated using the product-limit method of Kaplan and Meier. Progression defined as a 50% increase or an increase of 10 cm\^2 (whichever is smaller) in the sum of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, or reappearance of any lesion that had disappeared, or appearance of any new lesion/site, or failure to return for evaluation due to death or deteriorating condition. Progression-free survival defined as from first day of treatment until the date of first documented progression or date of death from any cause, whichever came first. If failure has not occurred, failure time is censored at the time of last follow-up.
Outcome measures
| Measure |
Treatment
n=31 Participants
Patients receive neoadjuvant induction chemotherapy comprising docetaxel IV over 1 hour on day 1 and cisplatin IV, leucovorin IV, and fluorouracil IV over 24 hours on days 1-4. Induction chemotherapy repeats every 28 days for 3 courses.
Patients with partial response at the primary site may undergo radical or functional resection of the primary tumor within 3 weeks of completion of neoadjuvant therapy.
Beginning within 4 weeks of completion of neoadjuvant therapy, patients with persistent disease or complete response after chemotherapy at the primary or neck then undergo radiotherapy 5 days a week for 7 weeks and receive gemcitabine hydrochloride IV over 30 minutes and cisplatin IV over 60 minutes on day 1 of each week of radiotherapy.
|
|---|---|
|
Progression-free Survival
|
170.5 Months
Interval 113.3 to
NA - 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
Treatment
Serious events: 9 serious events
Other events: 31 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
Treatment
n=31 participants at risk
Patients receive neoadjuvant induction chemotherapy comprising docetaxel IV over 1 hour on day 1 and cisplatin IV, leucovorin IV, and fluorouracil IV over 24 hours on days 1-4. Induction chemotherapy repeats every 28 days for 3 courses.
Patients with partial response at the primary site may undergo radical or functional resection of the primary tumor within 3 weeks of completion of neoadjuvant therapy.
Beginning within 4 weeks of completion of neoadjuvant therapy, patients with persistent disease or complete response after chemotherapy at the primary or neck then undergo radiotherapy 5 days a week for 7 weeks and receive gemcitabine hydrochloride IV over 30 minutes and cisplatin IV over 60 minutes on day 1 of each week of radiotherapy.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Cardiac disorders
Cardiac General - Other (Specify, __)
|
3.2%
1/31 • Number of events 2 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Gastrointestinal disorders
Diarrhea
|
6.5%
2/31 • Number of events 2 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Gastrointestinal disorders
Esophagitis
|
9.7%
3/31 • Number of events 3 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, __)
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Gastrointestinal disorders
Melena/GI bleeding
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)
|
9.7%
3/31 • Number of events 4 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Gastrointestinal disorders
Nausea
|
9.7%
3/31 • Number of events 3 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Gastrointestinal disorders
Vomiting
|
6.5%
2/31 • Number of events 2 • Adverse events occurred over a period of 3 years and 9 months.
|
|
General disorders
Pain - Other (Specify, __)
|
3.2%
1/31 • Number of events 2 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Infections and infestations
Infection with unknown ANC
|
6.5%
2/31 • Number of events 3 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Injury, poisoning and procedural complications
Mucositis due to radiation
|
6.5%
2/31 • Number of events 2 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Investigations
Creatinine
|
6.5%
2/31 • Number of events 2 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Investigations
Leukocytes (total WBC)
|
6.5%
2/31 • Number of events 2 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
6.5%
2/31 • Number of events 2 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
6.5%
2/31 • Number of events 2 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
12.9%
4/31 • Number of events 6 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
3.2%
1/31 • Number of events 2 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (Specify, __)
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Renal and urinary disorders
Renal failure
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Vascular disorders
Hypotension
|
6.5%
2/31 • Number of events 2 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
Other adverse events
| Measure |
Treatment
n=31 participants at risk
Patients receive neoadjuvant induction chemotherapy comprising docetaxel IV over 1 hour on day 1 and cisplatin IV, leucovorin IV, and fluorouracil IV over 24 hours on days 1-4. Induction chemotherapy repeats every 28 days for 3 courses.
Patients with partial response at the primary site may undergo radical or functional resection of the primary tumor within 3 weeks of completion of neoadjuvant therapy.
Beginning within 4 weeks of completion of neoadjuvant therapy, patients with persistent disease or complete response after chemotherapy at the primary or neck then undergo radiotherapy 5 days a week for 7 weeks and receive gemcitabine hydrochloride IV over 30 minutes and cisplatin IV over 60 minutes on day 1 of each week of radiotherapy.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __)
|
58.1%
18/31 • Number of events 27 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.9%
4/31 • Number of events 4 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
58.1%
18/31 • Number of events 31 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Skin and subcutaneous tissue disorders
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Skin and subcutaneous tissue disorders
Pigmentation changes (e.g., vitiligo)
|
22.6%
7/31 • Number of events 7 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
6.5%
2/31 • Number of events 2 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
51.6%
16/31 • Number of events 23 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
29.0%
9/31 • Number of events 12 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Vascular disorders
Flushing
|
25.8%
8/31 • Number of events 10 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Vascular disorders
Hemorrhage/Bleeding - Other (Specify, __)
|
19.4%
6/31 • Number of events 8 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Vascular disorders
Hypertension
|
19.4%
6/31 • Number of events 9 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Vascular disorders
Hypotension
|
51.6%
16/31 • Number of events 23 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Vascular disorders
Phlebitis (including superficial thrombosis)
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
6.5%
2/31 • Number of events 2 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC) for BMT studies, if specified in the protocol.
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
General disorders
Pain due to radiation
|
12.9%
4/31 • Number of events 5 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Infections and infestations
Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT studies, if specified in the protocol.
|
6.5%
2/31 • Number of events 3 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Blood and lymphatic system disorders
Transfusion: pRBCs for BMT studies, if specified in the protocol.
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Ear and labyrinth disorders
Vertigo
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other (Specify, __)
|
6.5%
2/31 • Number of events 3 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.5%
2/31 • Number of events 2 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
100.0%
31/31 • Number of events 100 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Blood and lymphatic system disorders
Lymphatics - Other (Specify, __)
|
12.9%
4/31 • Number of events 7 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Blood and lymphatic system disorders
Transfusion: Platelets
|
9.7%
3/31 • Number of events 3 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Blood and lymphatic system disorders
Transfusion: pRBCs
|
22.6%
7/31 • Number of events 8 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Cardiac disorders
Cardiac Arrhythmia - Other (Specify, __)
|
9.7%
3/31 • Number of events 7 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Cardiac disorders
Cardiac General - Other (Specify, __)
|
6.5%
2/31 • Number of events 5 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia
|
77.4%
24/31 • Number of events 50 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Ear and labyrinth disorders
Auditory/Ear - Other (Specify, __)
|
25.8%
8/31 • Number of events 11 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Endocrine disorders
Thyroid function, low (hypothyroidism)
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Eye disorders
Ocular/Visual - Other (Specify, __)
|
6.5%
2/31 • Number of events 2 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Eye disorders
Vision-blurred vision
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Gastrointestinal disorders
Constipation
|
67.7%
21/31 • Number of events 38 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Gastrointestinal disorders
Diarrhea
|
87.1%
27/31 • Number of events 51 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Gastrointestinal disorders
Diarrhea patients with a colostomy
|
12.9%
4/31 • Number of events 4 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
51.6%
16/31 • Number of events 20 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Gastrointestinal disorders
Esophagitis
|
64.5%
20/31 • Number of events 35 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Gastrointestinal disorders
Flatulence
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, __)
|
74.2%
23/31 • Number of events 75 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
48.4%
15/31 • Number of events 22 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Gastrointestinal disorders
Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Gastrointestinal disorders
Incontinence
|
6.5%
2/31 • Number of events 4 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Gastrointestinal disorders
Melena/GI bleeding
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)
|
93.5%
29/31 • Number of events 66 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Gastrointestinal disorders
Nausea
|
87.1%
27/31 • Number of events 81 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Gastrointestinal disorders
Proctitis
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Gastrointestinal disorders
Rectal bleeding/hematochezia
|
6.5%
2/31 • Number of events 2 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Gastrointestinal disorders
Salivary gland changes/saliva
|
9.7%
3/31 • Number of events 3 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Gastrointestinal disorders
Vomiting
|
87.1%
27/31 • Number of events 65 • Adverse events occurred over a period of 3 years and 9 months.
|
|
General disorders
Constitutional Symptoms - Other (Specify, __)
|
25.8%
8/31 • Number of events 14 • Adverse events occurred over a period of 3 years and 9 months.
|
|
General disorders
Edema
|
51.6%
16/31 • Number of events 26 • Adverse events occurred over a period of 3 years and 9 months.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
96.8%
30/31 • Number of events 81 • Adverse events occurred over a period of 3 years and 9 months.
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
35.5%
11/31 • Number of events 17 • Adverse events occurred over a period of 3 years and 9 months.
|
|
General disorders
Injection site reaction/extravasation changes
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
General disorders
Irritability (children <3 years of age)
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
General disorders
Pain - Other (Specify, __)
|
93.5%
29/31 • Number of events 142 • Adverse events occurred over a period of 3 years and 9 months.
|
|
General disorders
Rigors/chills
|
32.3%
10/31 • Number of events 14 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Infections and infestations
Infection
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Infections and infestations
Infection - Other (Specify, __)
|
3.2%
1/31 • Number of events 2 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Infections and infestations
Infection with unknown ANC
|
6.5%
2/31 • Number of events 2 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Infections and infestations
Infection without neutropenia
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Infections and infestations
Infection, Fungal (COH)
|
32.3%
10/31 • Number of events 11 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Infections and infestations
Infection, Viral (COH)
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Injury, poisoning and procedural complications
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
6.5%
2/31 • Number of events 2 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Injury, poisoning and procedural complications
Dysphagia-esophageal related to radiation
|
41.9%
13/31 • Number of events 14 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Injury, poisoning and procedural complications
Mucositis due to radiation
|
58.1%
18/31 • Number of events 18 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Injury, poisoning and procedural complications
Rash: dermatitis associated with radiation
|
58.1%
18/31 • Number of events 18 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Injury, poisoning and procedural complications
Wound complication, non-infectious
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
54.8%
17/31 • Number of events 27 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
61.3%
19/31 • Number of events 39 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Investigations
Alkaline phosphatase
|
29.0%
9/31 • Number of events 14 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
12.9%
4/31 • Number of events 6 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Investigations
Cholesterol, serum-high (hypercholesteremia)
|
45.2%
14/31 • Number of events 20 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Investigations
Creatinine
|
54.8%
17/31 • Number of events 32 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Investigations
INR (International Normalized Ratio of prothrombin time)
|
19.4%
6/31 • Number of events 9 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Investigations
Leukocytes (total WBC)
|
93.5%
29/31 • Number of events 63 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Investigations
Lymphopenia
|
77.4%
24/31 • Number of events 47 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Investigations
PTT (Partial Thromboplastin Time)
|
9.7%
3/31 • Number of events 3 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Investigations
Platelets
|
64.5%
20/31 • Number of events 39 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Investigations
Weight gain
|
16.1%
5/31 • Number of events 10 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Investigations
Weight loss
|
90.3%
28/31 • Number of events 57 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
90.3%
28/31 • Number of events 64 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
90.3%
28/31 • Number of events 73 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
6.5%
2/31 • Number of events 2 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
100.0%
31/31 • Number of events 78 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
74.2%
23/31 • Number of events 42 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
90.3%
28/31 • Number of events 67 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
32.3%
10/31 • Number of events 10 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
87.1%
27/31 • Number of events 56 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
48.4%
15/31 • Number of events 26 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
6.5%
2/31 • Number of events 3 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
87.1%
27/31 • Number of events 57 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
9.7%
3/31 • Number of events 3 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
93.5%
29/31 • Number of events 66 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Metabolism and nutrition disorders
Triglyceride, serum-high (hypertriglyceridemia)
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
22.6%
7/31 • Number of events 9 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Musculoskeletal and connective tissue disorders
Arthritis (non-septic)
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (Specify, __)
|
19.4%
6/31 • Number of events 17 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Nervous system disorders
Dizziness
|
61.3%
19/31 • Number of events 23 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Nervous system disorders
Extrapyramidal/involuntary movement/restlessness
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Nervous system disorders
Memory impairment
|
6.5%
2/31 • Number of events 3 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Nervous system disorders
Neurology - Other (Specify, __)
|
32.3%
10/31 • Number of events 17 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Nervous system disorders
Neuropathy: motor
|
48.4%
15/31 • Number of events 23 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Nervous system disorders
Neuropathy: sensory
|
45.2%
14/31 • Number of events 23 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Nervous system disorders
Pain
|
71.0%
22/31 • Number of events 50 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
6.5%
2/31 • Number of events 3 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Nervous system disorders
Speech impairment (e.g., dysphasia or aphasia)
|
6.5%
2/31 • Number of events 3 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Nervous system disorders
Syncope (fainting)
|
16.1%
5/31 • Number of events 5 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
35.5%
11/31 • Number of events 15 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Nervous system disorders
Tremor
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Psychiatric disorders
Confusion
|
12.9%
4/31 • Number of events 4 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Psychiatric disorders
Insomnia
|
58.1%
18/31 • Number of events 29 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Psychiatric disorders
Mood alteration
|
74.2%
23/31 • Number of events 62 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Psychiatric disorders
Personality/behavioral
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Renal and urinary disorders
Bladder spasms
|
3.2%
1/31 • Number of events 2 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Renal and urinary disorders
Hemoglobinuria
|
6.5%
2/31 • Number of events 3 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Renal and urinary disorders
Proteinuria
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Specify, __)
|
12.9%
4/31 • Number of events 6 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
22.6%
7/31 • Number of events 8 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
25.8%
8/31 • Number of events 8 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Renal and urinary disorders
Urine color change
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Reproductive system and breast disorders
Sexual/Reproductive Function - Other (Specify, __)
|
3.2%
1/31 • Number of events 2 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Reproductive system and breast disorders
Vaginal dryness
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
6.5%
2/31 • Number of events 2 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
38.7%
12/31 • Number of events 15 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
19.4%
6/31 • Number of events 6 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
16.1%
5/31 • Number of events 5 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory
|
12.9%
4/31 • Number of events 4 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
6.5%
2/31 • Number of events 2 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
3.2%
1/31 • Number of events 1 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, __)
|
41.9%
13/31 • Number of events 18 • Adverse events occurred over a period of 3 years and 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
29.0%
9/31 • Number of events 9 • Adverse events occurred over a period of 3 years and 9 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place