Afatinib After Chemoradiation and Surgery in Treating Patients With Stage III-IV Squamous Cell Carcinoma of the Head and Neck at High-Risk of Recurrence
|Head and Neck Squamous Cell Carcinoma||Drug: afatinib Other: placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized Placebo Controlled Phase II Trial of Afatinib (BIBW2992) as Adjuvant Therapy Following Chemoradiation in Patients With Head and Neck Squamous Cell Carcinoma at High Risk of Recurrence|
- Disease-free Survival (DFS) [ Time Frame: Assessed every 3 months for patients < 2 years from registration and every 6 months if patient is 2-3 years from registration and every 12 months if patient is 4-5 years from registration ]DFS is defined as the time from randomization to the earlier of disease recurrence, second primary cancer, or death without recurrence.
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||January 2020|
|Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Experimental: Arm A (afatinib)
Patients receive afatinib PO QD on days 1-28.
Other Name: BIBW 2992
Placebo Comparator: Arm B (placebo)
Patients receive placebo PO QD on days 1-28.
I. Examine disease-free survival (DFS) given afatinib/placebo adjuvant therapy in patients with viable tumors in lymph nodes after neck dissection for suspected residual disease after concurrent chemoradiation.
I. Evaluate the recurrence rate, recurrence patterns, development of second primary malignancies, overall survival (OS) and toxicity of afatinib/placebo.
II. Evaluate on-target inhibition by afatinib, and determine circulating deoxyribonucleic acid (DNA) as a biomarker of afatinib resistance.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients receive afatinib orally (PO) once daily (QD) on days 1-28.
ARM B: Patients receive placebo PO QD on days 1-28.
In both Arms, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 1 year and then every 12 months for 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01824823
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|Principal Investigator:||Christine Chung||Eastern Cooperative Oncology Group|