CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 702 enrolled
Drug / intervention
cetuximab +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00956007
NCT00956007Phase 3Active

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

Radiation Therapy Oncology Group·interventional·Posted Aug 11, 2009·Updated Jan 6, 2026

In Brief

A Phase 3 clinical trial evaluating cetuximab and intensity-modulated radiation therapy for Head and Neck Cancer. Active but no longer recruiting, targeting 702 participants across 264 sites in 4 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, China, Saudi Arabia, United States

Timeline

Phase 3Active
201020112012201320142015201620172018201920202021202220232024202520262027202820292030
First PostedAug 11, 2009
Enrollment StartMar 31, 2010
Primary CompletionSep 5, 2023
Study CompletionAug 1, 2029
TodayJul 2, 2026
Enrollment to primary: 13.4 yearsPosted 16.9 years ago

Interventions

cetuximabbiological

intravenously

intensity-modulated radiation therapyradiation

daily fractions