Conditions: Head and Neck Squamous Cell Carcinoma
Keywords: afatinib head and neck squamous cell carcinoma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 3
Healthy volunteers: no

Brief summary:
This randomized phase II trial studies how well giving afatinib after chemoradiation and surgery works in treating patients with stage III-IV squamous cell carcinoma of the head and neck at high-risk of recurrence. Afatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
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 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.

Arms:
arm 1: Patients receive afatinib PO QD on days 1-28. arm 2: Patients receive placebo PO QD on days 1-28.

Interventions: intervention 1: afatinib intervention 2: placebo
Intervention descriptions: intervention 1: Given PO intervention 2: Given PO

Protocol document: