Trial ID or NCT#

NCT00956007

Status

not recruiting iconNOT RECRUITING

Purpose

RATIONALE: Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor, and giving radiation therapy in higher doses over a shorter period of time, may kill more tumor cells and have fewer side effects. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether radiation therapy is more effective when given alone or together with cetuximab in treating patients with head and neck cancer that has been removed by surgery. PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with cetuximab in treating patients who have undergone surgery for locally advanced head and neck cancer.

Official Title

A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Quynh-Thu Le, MD
Quynh-Thu Le, MD
Radiation oncologist
Katharine Dexter McCormick and Stanley McCormick Memorial Professor and Professor, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS)
Daniel Chang
Daniel Chang
Radiation oncologist
Sue and Bob McCollum Professor
A. Dimitrios Colevas
A. Dimitrios Colevas
Medical oncologist, Head and neck specialist, Cutaneous oncology specialist
Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)
Michael J. Kaplan, MD
Harlan Pinto
Harlan Pinto
Medical oncologist, Head and neck specialist
Associate Professor of Medicine (Oncology) and of Otolaryngology - Head & Neck Surgery

Contact us to find out if this trial is right for you.

CONTACT

Cancer Clinical Trials Office
(650) 498-7061