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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Related Information
Registry Information

Alternate Title

Phase III Randomized Study of Concurrent Accelerated Fractionated Radiotherapy and Cisplatin With Versus Without Cetuximab in Patients With Stage III or IV Squamous Cell Carcinoma of the Oropharynx, Hypopharynx, or Larynx

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over	NCI	RTOG-0522 RTOG 0522, NCT00265941

Special Category: NCI Web site featured trial, CTSU trial, NCI - CMS pilot project trial

Trial Description

Purpose:

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.

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.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Cancer of the oropharynx, hypopharynx, or larynx
• No distant metastases
• No previous chemotherapy for this cancer
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.

Patients in group one will undergo radiation therapy once or twice a day 5-6 days a week for 6 weeks. They will also receive a 1-hour infusion of cisplatin once in weeks 1 and 4 of radiation therapy.

Patients in group two will receive a 1- to 2-hour infusion of cetuximab once a week for 8 weeks. Beginning 1 week after the start of cetuximab, they will also undergo radiation therapy once or twice a day 5-6 days a week for 6 weeks and receive a 1-hour infusion of cisplatin once in weeks 1 and 4 of radiation therapy.

Approximately 9-10 weeks later, some patients in both groups may undergo surgery to remove the tumor.

Quality of life will be assessed periodically. After finishing treatment, patients will be evaluated periodically for 5 years and once a year thereafter.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

K. Kian Ang, MD, PhD, Principal investigator		Ph: 713-563-2300; 800-392-1611

Related Information

Featured trial article

Registry Information
Official Title		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
Trial Start Date		2005-11-22
Trial Completion Date		2014-06-01 (estimated)
Registered in ClinicalTrials.gov		NCT00265941
Date Submitted to PDQ		2005-11-15
Information Last Verified		2009-03-03
NCI Grant/Contract Number		CA21661