CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 940 enrolled
Drug / intervention
cetuximab +3 moredrug
Likely dose
cetuximab 400 mgfrom 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/NCT00265941
NCT00265941Phase 3Completed

A Randomized Phase III Trial of Concurrent Accelerated Radiation and Cisplatin Versus Concurrent Accelerated Radiation, Cisplatin, and Cetuximab (C225) [Followed by Surgery for Selected Patients] for Stage III and IV Head and Neck Carcinomas

Radiation Therapy Oncology Group·interventional·Posted Dec 15, 2005·Updated Jun 14, 2022

In Brief

A Phase 3 clinical trial evaluating cetuximab, cisplatin, and 2 other interventions for Head and Neck Cancer. Completed, enrolled 940 participants across 372 sites in 2 countries.

Detailed Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cisplatin may also make tumor cells more sensitive to radiation therapy. 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. Giving radiation therapy and cisplatin together with cetuximab may kill more tumor cells. It is not yet known whether radiation therapy and cisplatin are more effective with or without cetuximab in treating head and neck cancer. PURPOSE: This randomized phase III trial is studying radiation therapy, cisplatin, and cetuximab to see how well they work compared to radiation therapy and cisplatin in treating patients with stage III or stage IV head and neck cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 15, 2005
Enrollment StartNov 1, 2005
Primary CompletionJan 1, 2011
Study CompletionMay 20, 2022
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 20.5 years ago

Interventions

cetuximabdrug

Cetuximab 400 mg/m\^2 IV loading dose 5-7 days before start of radiation therapy, then 250 mg/m\^2 IV weekly for 7 weeks

cisplatindrug

Cisplatin 100 mg/m\^2 IV on days 1 and 22

Accelerated Fractionation by Concomitant Boostradiation

3DCRT 54 Gy in 30 1.8 Gy fractions over 6 weeks with boost 18 Gy in 12 1.5 Gy fractions for last 12 days, for a total of 72 Gy in 42 fractions over 6 weeks

Intensity-modulated radiation therapyradiation

70 Gy in 35 2.0 Gy fractions over 6 weeks with 6 fractions per week (on Saturday or as second daily fraction) in 5 of the 6 weeks.