Trial Outcomes & Findings for Phase II Study of Concurrent C225, Cisplatin and Radiation in Stage IV Squamous Cell Carcinoma of the Head and Neck (NCT NCT00096174)
NCT ID: NCT00096174
Last Updated: 2023-06-29
Results Overview
Two-year progression-free survival rate was defined as the proportion of patients that were alive progression-free two years after registration into the study. Disease progression was assessed per modified RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, in either primary or nodal lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of new lesions. Kaplan-Meier estimate of 2-year progression-free survival was calculated in the 60 eligible and treated patients.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
69 participants
Primary outcome timeframe
assessed every 3 months for 2 years
Results posted on
2023-06-29
Participant Flow
The study was open to accrual on 12/21/2004, accrued its first patient on April 8, 2005, and was closed on 07/20/2006. The final accrual was 69 patients.
Participant milestones
| Measure |
Cisplatin, C225, Radiation
* Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57.
* Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57.
* Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months.
|
|---|---|
|
Overall Study
STARTED
|
69
|
|
Overall Study
Began Protocol Therapy
|
66
|
|
Overall Study
Eligible and Treated
|
60
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
62
|
Reasons for withdrawal
| Measure |
Cisplatin, C225, Radiation
* Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57.
* Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57.
* Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months.
|
|---|---|
|
Overall Study
Lack of Efficacy
|
9
|
|
Overall Study
Adverse Event
|
15
|
|
Overall Study
Death
|
6
|
|
Overall Study
Withdrawal by Subject
|
15
|
|
Overall Study
Not started protocol therapy
|
3
|
|
Overall Study
Ineligible
|
6
|
|
Overall Study
other reason
|
8
|
Baseline Characteristics
Phase II Study of Concurrent C225, Cisplatin and Radiation in Stage IV Squamous Cell Carcinoma of the Head and Neck
Baseline characteristics by cohort
| Measure |
Cisplatin, C225, Radiation
n=60 Participants
* Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57.
* Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57.
* Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months.
|
|---|---|
|
Age, Continuous
|
54.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: assessed every 3 months for 2 yearsPopulation: Eligible and treated
Two-year progression-free survival rate was defined as the proportion of patients that were alive progression-free two years after registration into the study. Disease progression was assessed per modified RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, in either primary or nodal lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of new lesions. Kaplan-Meier estimate of 2-year progression-free survival was calculated in the 60 eligible and treated patients.
Outcome measures
| Measure |
Cisplatin, C225, Radiation
n=60 Participants
* Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57.
* Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57.
* Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months.
|
|---|---|
|
2-year Progression-free Survival Rate
|
47 proportion of participants
Interval 33.0 to 61.0
|
SECONDARY outcome
Timeframe: assessed very 3 months for 2 yearsPopulation: Eligible and treated
Overall survival was defined as time from registration to death from any cause. Patients alive at last follow-up were censored. The 2-year overall survival rate was defined as the percentage of patients that were still alive two years after registration into the study. Kaplan-Meier estimate of 2-year overall survival was calculated in the 60 eligible and treated patients.
Outcome measures
| Measure |
Cisplatin, C225, Radiation
n=60 Participants
* Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57.
* Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57.
* Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months.
|
|---|---|
|
2-year Overall Survival Rate
|
66 proportion of participants
Interval 54.0 to 78.0
|
SECONDARY outcome
Timeframe: assessed after all chemoradiation therapy completed Week 9, then every 3 months on C225 maintenance therapy, and every 3 months for 2 years, every 6 months post-treatment 2 years from study entryPopulation: Eligible and treated
Response was assessed per Response Evaluation in Solid Tumor (RECIST) criteria by physical assessment and CT. Overall response = complete response (CR) + partial response (PR). CR was defined as the disappearance of all target and non-target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions, along with non-progressive disease of non-target lesions. Overall response rate (i.e., proportion of patients who had CR or PR) and the corresponding 90% confidence intervals were calculated for the 60 eligible and treated patients
Outcome measures
| Measure |
Cisplatin, C225, Radiation
n=60 Participants
* Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57.
* Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57.
* Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months.
|
|---|---|
|
Overall Response Rate
|
66.7 proportion of participants
Interval 55.3 to 76.7
|
Adverse Events
Cisplatin, C225, Radiation
Serious events: 64 serious events
Other events: 66 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cisplatin, C225, Radiation
n=66 participants at risk
* Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57.
* Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57.
* Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months.
|
|---|---|
|
Ear and labyrinth disorders
Hearing w/w-o audiogr in monitor prg
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Ear and labyrinth disorders
Hearing w/w-o audiogr not in monitor prg
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
6.1%
4/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Investigations
Leukopenia
|
28.8%
19/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Investigations
Lymphopenia
|
3.0%
2/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Investigations
Neutrophenia
|
25.8%
17/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Investigations
Thrombocytopenia
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Vascular disorders
Hypotension
|
6.1%
4/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
General disorders
Fatigue
|
22.7%
15/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
General disorders
Fever w/o neutropenia
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Psychiatric disorders
Insomnia
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Investigations
Weight loss
|
27.3%
18/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
25.8%
17/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Injury, poisoning and procedural complications
Radiation dermatitis
|
18.2%
12/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Injury, poisoning and procedural complications
Wound - non-infectious
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
12.1%
8/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
34.8%
23/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Gastrointestinal disorders
Constipation
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
19.7%
13/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Gastrointestinal disorders
Dental problems
|
3.0%
2/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
4.5%
3/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
11/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
45.5%
30/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Gastrointestinal disorders
Esophagitis
|
3.0%
2/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
6.1%
4/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, pharynx
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) anus
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral cavity
|
54.5%
36/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Gastrointestinal disorders
Salivary problems
|
6.1%
4/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Gastrointestinal disorders
Nausea
|
19.7%
13/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
6/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Larynx, hemorrhage
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
4.5%
3/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Investigations
Alkaline phosphatase increased
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Metabolism and nutrition disorders
Alkalosis
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Hepatobiliary disorders
ALT increased
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Hepatobiliary disorders
AST increased
|
3.0%
2/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Metabolism and nutrition disorders
Bilirubin increased
|
3.0%
2/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.5%
3/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Investigations
Creatinine increased
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.0%
2/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.1%
4/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.6%
5/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
19.7%
13/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
21.2%
14/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Psychiatric disorders
Confusion
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Nervous system disorders
Dizziness
|
3.0%
2/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Psychiatric disorders
Agitation
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Psychiatric disorders
Depression
|
3.0%
2/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Nervous system disorders
Neuropathy-motor
|
3.0%
2/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Nervous system disorders
Seizure
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Nervous system disorders
Syncope
|
4.5%
3/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Eye disorders
Ocular-other
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Gastrointestinal disorders
Abdomen, pain
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Musculoskeletal and connective tissue disorders
Back, pain
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Cardiac disorders
Chest/thoracic pain NOS
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Gastrointestinal disorders
Esophagus, pain
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Nervous system disorders
Head/headache
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck, pain
|
3.0%
2/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Gastrointestinal disorders
Oral cavity, pain
|
7.6%
5/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
General disorders
Pain NOS
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Skin and subcutaneous tissue disorders
Skin, pain
|
3.0%
2/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Throat/pharynx/larynx, pain
|
6.1%
4/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Edema, larynx
|
3.0%
2/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.0%
2/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
6.1%
4/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Renal and urinary disorders
Renal failure
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Infections and infestations
Infection w/ gr3-4 neut, lung
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Infections and infestations
Infection w/ gr3-4 neut, urinary tract
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Infections and infestations
Infection Gr0-2 neut, abdomen
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Infections and infestations
Infection Gr0-2 neut, foreign body
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Infections and infestations
Infection Gr0-2 neut, lung
|
3.0%
2/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Infections and infestations
Infection Gr0-2 neut, oral cavity
|
4.5%
3/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Infections and infestations
Infection Gr0-2 neut, skin
|
6.1%
4/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Infections and infestations
Infection Gr0-2 neut, upper airway
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Infections and infestations
Infection w/ unk ANC bronchus
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Infections and infestations
Infection w/ unk ANC conjunctiva
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Infections and infestations
Infection w/ gr3-4 neut, blood
|
1.5%
1/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Infections and infestations
Infection Gr0-2 neut, blood
|
4.5%
3/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
Other adverse events
| Measure |
Cisplatin, C225, Radiation
n=66 participants at risk
* Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57.
* Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57.
* Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months.
|
|---|---|
|
Ear and labyrinth disorders
Hearing w/o audiogr not in monitor prg
|
7.6%
5/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Ear and labyrinth disorders
Tinnitus
|
7.6%
5/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
90.9%
60/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Investigations
Leukopenia
|
83.3%
55/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Investigations
Neutropenia
|
51.5%
34/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Investigations
Thrombocytopenia
|
30.3%
20/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Vascular disorders
Hypotension
|
18.2%
12/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
General disorders
Fatigue
|
83.3%
55/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
General disorders
Fever w/o neutropenia
|
22.7%
15/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Psychiatric disorders
Insomnia
|
12.1%
8/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
General disorders
Rigor/chills
|
6.1%
4/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Investigations
Weight loss
|
86.4%
57/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Injury, poisoning and procedural complications
Burn
|
18.2%
12/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
43.9%
29/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
22.7%
15/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
10.6%
7/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Skin and subcutaneous tissue disorders
Rash: ache/acneiform
|
87.9%
58/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Injury, poisoning and procedural complications
Radiation dermatitis
|
27.3%
18/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
47.0%
31/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Gastrointestinal disorders
Anorexia
|
68.2%
45/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Gastrointestinal disorders
Constipation
|
50.0%
33/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
18.2%
12/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Gastrointestinal disorders
Dental problems
|
7.6%
5/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
31.8%
21/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Gastrointestinal disorders
Dry mouth
|
57.6%
38/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
72.7%
48/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
13.6%
9/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral activity
|
7.6%
5/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral activity
|
89.4%
59/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Gastrointestinal disorders
Nausea
|
75.8%
50/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Gastrointestinal disorders
Salivary problems
|
39.4%
26/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Gastrointestinal disorders
Taste disturbance
|
40.9%
27/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Gastrointestinal disorders
Vomiting
|
51.5%
34/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Infections and infestations
Infection Gr0-2 neut,oral cavity
|
9.1%
6/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Infections and infestations
Infection Gr0-2 neut,skin
|
6.1%
4/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
74.2%
49/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Investigations
Alkaline phosphatase
|
34.8%
23/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Hepatobiliary disorders
ALT increased
|
51.5%
34/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Hepatobiliary disorders
AST increased
|
39.4%
26/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Hepatobiliary disorders
Bilirubin
|
7.6%
5/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
6.1%
4/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
36.4%
24/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Investigations
Creatinine
|
27.3%
18/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.1%
8/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
9.1%
6/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
69.7%
46/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
12.1%
8/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
45.5%
30/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
13.6%
9/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
71.2%
47/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Nervous system disorders
Dizziness
|
9.1%
6/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Psychiatric disorders
Anxiety
|
6.1%
4/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Psychiatric disorders
Depression
|
16.7%
11/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Nervous system disorders
Neutropathy-sensory
|
12.1%
8/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Gastrointestinal disorders
Abdomen,pain
|
16.7%
11/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Nervous system disorders
Head/headache
|
19.7%
13/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Ear and labyrinth disorders
Middle ear, pain
|
9.1%
6/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Gastrointestinal disorders
Oral cavity, pain
|
27.3%
18/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Skin and subcutaneous tissue disorders
Skin, pain
|
6.1%
4/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Throat/pharynx/larynx, pain
|
33.3%
22/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
6/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.6%
7/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Edema, larynx
|
7.6%
5/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs
|
6.1%
4/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
27.3%
18/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
12.1%
8/66 • Assessed weekly while on treatment, and every 3 months for 2 years
|
Additional Information
Study Statistician
Eastern Cooperative Oncology Group (ECOG) Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place