Trial Outcomes & Findings for Induction Chemotherapy Followed By Cetuximab and Radiation in HPV-Associated Resectable Stage III/IV Oropharynx Cancer (NCT NCT01084083)
NCT ID: NCT01084083
Last Updated: 2023-06-28
Results Overview
24-month progression-free survival is defined as the proportion of patients who were alive and progression-free at 24 months post registration. The primary study population for this endpoint is patients who were confirmed post-induction clinical complete response (CR) at their primary sites and subsequently received 5400 cGy radiation therapy to their primary sites.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
90 participants
Primary outcome timeframe
assessed within 14 days after delivery of the third cycle of induction therapy, and 8 weeks and 6 months after completion of concurrent therapy, then every 6 months until progression or until 3 years from study entry
Results posted on
2023-06-28
Participant Flow
The study was activated on March 17, 2010, accrued its first patient on August 11, 2010, and closed to accrual on October 19, 2011, with an accrual of 90 patients from 16 ECOG-affiliated institutions.
Participant milestones
| Measure |
Overall
Patients receive cisplatin IV on day 1 and paclitaxel IV and cetuximab IV on days 1, 8, and 15. Treatment repeats every 21 days for 3 courses. Patients then undergo evaluation of response to induction therapy. Patients with a CR at the primary tumor site proceed to group 1 of concurrent low-dose IMRT and cetuximab. Patients with a PR or SD at the primary tumor site or those with grossly positive disease at the primary tumor site proceed to group 2 of concurrent standard dose IMRT and cetuximab.
|
|---|---|
|
Overall Study
STARTED
|
90
|
|
Overall Study
Treated
|
89
|
|
Overall Study
Eligible
|
81
|
|
Overall Study
Eligible and Treated
|
80
|
|
Overall Study
CR to Induction Therapy
|
56
|
|
Overall Study
CR and Treated With 5400 cGy IMRT
|
44
|
|
Overall Study
COMPLETED
|
78
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Overall
Patients receive cisplatin IV on day 1 and paclitaxel IV and cetuximab IV on days 1, 8, and 15. Treatment repeats every 21 days for 3 courses. Patients then undergo evaluation of response to induction therapy. Patients with a CR at the primary tumor site proceed to group 1 of concurrent low-dose IMRT and cetuximab. Patients with a PR or SD at the primary tumor site or those with grossly positive disease at the primary tumor site proceed to group 2 of concurrent standard dose IMRT and cetuximab.
|
|---|---|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Death
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Complicating disease
|
1
|
|
Overall Study
Other
|
2
|
|
Overall Study
Never started assigned therapy
|
1
|
Baseline Characteristics
Induction Chemotherapy Followed By Cetuximab and Radiation in HPV-Associated Resectable Stage III/IV Oropharynx Cancer
Baseline characteristics by cohort
| Measure |
Eligible and Treated Patients
n=80 Participants
Patients receive cisplatin IV on day 1 and paclitaxel IV and cetuximab IV on days 1, 8, and 15. Treatment repeats every 21 days for 3 courses. Patients then undergo evaluation of response to induction therapy. Patients with a CR at the primary tumor site proceed to group 1 of concurrent low-dose IMRT and cetuximab. Patients with a PR or SD at the primary tumor site or those with grossly positive disease at the primary tumor site proceed to group 2 of concurrent standard dose IMRT and cetuximab.
|
|---|---|
|
Age, Continuous
|
57 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
80 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: assessed within 14 days after delivery of the third cycle of induction therapy, and 8 weeks and 6 months after completion of concurrent therapy, then every 6 months until progression or until 3 years from study entryPopulation: patients who were confirmed post-induction clinical complete response (CR) at their primary sites and subsequently received 5400 cGy radiation therapy to their primary sites
24-month progression-free survival is defined as the proportion of patients who were alive and progression-free at 24 months post registration. The primary study population for this endpoint is patients who were confirmed post-induction clinical complete response (CR) at their primary sites and subsequently received 5400 cGy radiation therapy to their primary sites.
Outcome measures
| Measure |
Primary Study Population
n=44 Participants
The primary study population for this endpoint is patients who were confirmed post-induction clinical complete response (CR) at their primary sites and subsequently received 5400 cGy radiation therapy to their primary sites.
|
|---|---|
|
24-month Progression-free Survival
|
64 percentage of participants
Interval 48.0 to 78.0
|
SECONDARY outcome
Timeframe: assessed within 14 days after delivery of the third cycle of induction therapy, and 8 weeks and 6 months after completion of concurrent therapy, then every 6 months until progression or until 3 years from study entryPopulation: eligible and treated patients
OS was defined as the time from registration to death, or censored at last date known alive. Kaplan-Meier method was used to estimate the overall survival rate at 24 months.
Outcome measures
| Measure |
Primary Study Population
n=80 Participants
The primary study population for this endpoint is patients who were confirmed post-induction clinical complete response (CR) at their primary sites and subsequently received 5400 cGy radiation therapy to their primary sites.
|
|---|---|
|
24-months Overall Survival
|
91 percentage of participants
Interval 82.0 to 96.0
|
SECONDARY outcome
Timeframe: assessed within 14 days after delivery of the third cycle of induction therapyPopulation: eligible and treated patients
Primary clinical response rate is defined as the proportion of patients with complete response or partial response at their primary sites after induction therapy. Response status for the primary site was classified by clinical examination using endoscopy. If, however, the clinical response status of the primary was unclear based on endoscopy, then the CT or MRI (required at the end of induction) was used to determine status of the primary. If clinical and radiological evaluation of the primary was unclear, a biopsy was considered at the discretion of the treating physician.
Outcome measures
| Measure |
Primary Study Population
n=80 Participants
The primary study population for this endpoint is patients who were confirmed post-induction clinical complete response (CR) at their primary sites and subsequently received 5400 cGy radiation therapy to their primary sites.
|
|---|---|
|
Primary Clinical Response Rate
|
73 percentage of participants
Interval 61.0 to 82.0
|
Adverse Events
All Treated Patients
Serious events: 69 serious events
Other events: 86 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Treated Patients
n=89 participants at risk
Patients receive cisplatin IV on day 1 and paclitaxel IV and cetuximab IV on days 1, 8, and 15. Treatment repeats every 21 days for 3 courses. Patients then undergo evaluation of response to induction therapy. Patients with a CR at the primary tumor site proceed to group 1 of concurrent low-dose IMRT and cetuximab. Patients with a PR or SD at the primary tumor site or those with grossly positive disease at the primary tumor site proceed to group 2 of concurrent standard dose IMRT and cetuximab.
Adverse events data were reported for all patients received at least one dose of protocol therapy.
|
|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
1.1%
1/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Blood and lymphatic system disorders
Anemia
|
2.2%
2/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.1%
1/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Cardiac disorders
Chest pain - cardiac
|
1.1%
1/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Cardiac disorders
Myocardial infarction
|
1.1%
1/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
General disorders
Fatigue
|
7.9%
7/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
General disorders
Pain
|
1.1%
1/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.1%
1/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia
|
1.1%
1/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
32.6%
29/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.4%
3/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
2.2%
2/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Gastrointestinal disorders
Constipation
|
1.1%
1/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Gastrointestinal disorders
Diarrhea
|
4.5%
4/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Gastrointestinal disorders
Dry mouth
|
4.5%
4/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Gastrointestinal disorders
Dysphagia
|
22.5%
20/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Gastrointestinal disorders
Mucositis oral
|
32.6%
29/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Gastrointestinal disorders
Nausea
|
9.0%
8/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Gastrointestinal disorders
Oral pain
|
6.7%
6/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
2/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
1.1%
1/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Immune system disorders
Anaphylaxis
|
1.1%
1/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Infections and infestations
Anorectal infection
|
1.1%
1/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Infections and infestations
Catheter related infection
|
1.1%
1/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Infections and infestations
Device related infection
|
1.1%
1/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Infections and infestations
Pharyngitis
|
1.1%
1/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Infections and infestations
Sepsis
|
2.2%
2/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
10.1%
9/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Injury, poisoning and procedural complications
Wound complication
|
1.1%
1/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Investigations
Alanine aminotransferase increased
|
2.2%
2/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Investigations
Aspartate aminotransferase increased
|
1.1%
1/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Investigations
Cardiac troponin I increased
|
1.1%
1/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Investigations
CD4 lymphocytes decreased
|
1.1%
1/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Investigations
Lymphocyte count decreased
|
20.2%
18/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Investigations
Neutrophil count decreased
|
11.2%
10/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Investigations
Weight loss
|
3.4%
3/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Investigations
White blood cell decreased
|
5.6%
5/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Metabolism and nutrition disorders
Anorexia
|
11.2%
10/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Metabolism and nutrition disorders
Dehydration
|
7.9%
7/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.1%
1/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
1.1%
1/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
1.1%
1/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.9%
7/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.2%
2/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.5%
4/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
1.1%
1/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.1%
1/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
1.1%
1/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.1%
1/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
1.1%
1/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.1%
1/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Musculoskeletal and connective tissue disorders
Superficial soft tissue fibrosis
|
1.1%
1/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Nervous system disorders
Headache
|
1.1%
1/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Nervous system disorders
Neuralgia
|
1.1%
1/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.1%
1/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.2%
2/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
1.1%
1/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.1%
1/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.4%
3/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.1%
1/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
2.2%
2/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
1.1%
1/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Vascular disorders
Hypotension
|
2.2%
2/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Vascular disorders
Thromboembolic event
|
4.5%
4/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
Other adverse events
| Measure |
All Treated Patients
n=89 participants at risk
Patients receive cisplatin IV on day 1 and paclitaxel IV and cetuximab IV on days 1, 8, and 15. Treatment repeats every 21 days for 3 courses. Patients then undergo evaluation of response to induction therapy. Patients with a CR at the primary tumor site proceed to group 1 of concurrent low-dose IMRT and cetuximab. Patients with a PR or SD at the primary tumor site or those with grossly positive disease at the primary tumor site proceed to group 2 of concurrent standard dose IMRT and cetuximab.
Adverse events data were reported for all patients received at least one dose of protocol therapy.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
15.7%
14/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
General disorders
Fatigue
|
50.6%
45/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
43.8%
39/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.6%
5/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.9%
7/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
71.9%
64/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
18.0%
16/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Gastrointestinal disorders
Constipation
|
11.2%
10/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Gastrointestinal disorders
Diarrhea
|
10.1%
9/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Gastrointestinal disorders
Dry mouth
|
40.4%
36/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Gastrointestinal disorders
Dysphagia
|
30.3%
27/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Gastrointestinal disorders
Mucositis oral
|
56.2%
50/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Gastrointestinal disorders
Nausea
|
36.0%
32/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Gastrointestinal disorders
Oral pain
|
15.7%
14/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Gastrointestinal disorders
Vomiting
|
9.0%
8/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
25.8%
23/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Investigations
Lymphocyte count decreased
|
15.7%
14/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Investigations
Neutrophil count decreased
|
16.9%
15/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Investigations
Weight loss
|
34.8%
31/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Investigations
White blood cell decreased
|
25.8%
23/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Metabolism and nutrition disorders
Anorexia
|
32.6%
29/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Metabolism and nutrition disorders
Dehydration
|
13.5%
12/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.1%
9/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.6%
5/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
18.0%
16/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Nervous system disorders
Dysgeusia
|
29.2%
26/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
14.6%
13/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
12.4%
11/89 • Assessed every cycle while on treatment and for 3 months after completion of concurrent treatment to capture late radiation toxicities
|
Additional Information
ECOG-ACRIN statistician
ECOG-ACRIN Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60