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
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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 I: Patients receive afatinib orally (PO) once daily (QD) on days 1-28.
ARM II: 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 1 year.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
DFS
Kaplan-Meier estimates will be calculated, along with their corresponding 95% confidence intervals (CIs). Comparison between arms will be performed via the log-rank test.
From randomization to the earlier of disease recurrence, second primary cancer, or death without recurrence, assessed up to 5 years
No
Christine Chung
Principal Investigator
Eastern Cooperative Oncology Group
United States: Institutional Review Board
E1311
NCT01824823
February 2013
Name | Location |
---|---|
Eastern Cooperative Oncology Group | Boston, Massachusetts 02215 |