A Randomized Phase II Trial of Concurrent Chemoradiation With Cetuximab (ERBITUX®), 5 Fluorouracil, Hydroxyurea, and Twice-daily Radiation (CetuxFHX) Versus Cetuximab (ERBITUX®), Cisplatin, and Accelerated Radiation With Concomitant Boost (CetuxPX) After Induction Chemotherapy in Patients With Locally Advanced Head and Neck Cancer (EPIC)

NCT00468169 Phase 2 COMPLETED Results posted

The main purpose of this study is to explore and compare the efficacy of Cetuximab (ERBITUX®) added to two concurrent chemoradiotherapy platforms of different intensity in locally advanced head and neck cancer.

Details

Lead sponsor	University of Chicago
Phase	Phase 2
Status	COMPLETED
Enrolment	110
Start date	2006-07
Completion	2012-11

Conditions

• Head and Neck Cancer

Interventions

• Cetuximab
• 5-FU
• Hydroxyurea
• Twice-daily radiation
• Cisplatin
• Accelerated fraction radiotherapy with concomitant boost

Primary outcomes

• Progression Free Survival (PFS) — 1 years
  Kaplan-Meier estimate of PFS at 1 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
• Progression Free Survival (PFS) — 2 years
  Time from randomization until disease progression or death from any cause. Kaplan-Meier estimate of PFS at 2 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Countries

United States