Who is sponsoring NCT01824823?

NCT01824823 is sponsored by ECOG-ACRIN Cancer Research Group.

What condition does NCT01824823 study?

NCT01824823 studies Head and Neck Squamous Cell Carcinoma.

What drugs are being tested in NCT01824823?

Interventions: afatinib, placebo.

What is the status of NCT01824823?

NCT01824823 is currently TERMINATED.

Last reviewed 2023-06-13 · How we verify

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

NCT01824823 Phase 2 TERMINATED Results posted

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.

Details

Lead sponsor	ECOG-ACRIN Cancer Research Group
Phase	Phase 2
Status	TERMINATED
Enrolment	3
Start date	2014-06-30
Completion	2020-12

Conditions

Head and Neck Squamous Cell Carcinoma

Interventions

afatinib
placebo

Primary outcomes

Disease-free Survival (DFS) — 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.

Countries

United States