|
||||||||||||||||||||||
|
|
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
Special Category: NCI Web site featured trial, CTSU trial, NCI - CMS pilot project trial Trial Description 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 criteria include the following:
Final eligibility for a clinical trial is determined by the health professionals conducting the trial. 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 Lead Organizations Radiation Therapy Oncology Group
Related Information
|
NCI Home |
Images Version |
Contact Us |
Policies |
Accessibility |
Viewing Files |
FOIA |
Site Help |
Site Map
|
A Service of the National Cancer Institute |