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

Alternate Title

Phase III Randomized Study of Adjuvant Chemotherapy Comprising S-1 Versus Tegafur-Uracil (UFT) in Patients With Definitively Treated Stage III or IV Squamous Cell Carcinoma of the Head and Neck

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	20 to 75	Other	YCU-BRI-HN-05-01 NCT00336947

Trial Description

Purpose:

Drugs used in chemotherapy, such as S-1 and tegafur - uracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving S-1 or tegafur-uracil after surgery, chemotherapy, biological therapy, and/or radiation therapy may kill any remaining tumor cells. It is not yet known whether S-1 is more effective than tegafur-uracil in treating head and neck cancer.

This randomized phase III trial is studying S-1 to see how well it works compared with tegafur-uracil in treating patients with previously treated stage III or stage IV head and neck cancer.

Eligibility:

Eligibility criteria include the following:

• 20-75 years old
• Finished treatment for this cancer within the past 3 months
• No distant metastasis
• 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 receive S-1 by mouth once a day for 2 weeks. Treatment may repeat every 3 weeks for up to 1 year.

Patients in group two will receive tegafur-uracil by mouth once a day. Treatment may continue for up to 1 year.

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

Yokohama City University

Mamoru Tsukuda, MD, Protocol chair		Ph: 81-45-787-2685 Email: mtsukuda@med.yokohama-cu.ac.jp

Registry Information
Official Title		Controlled Randomized Trial to Evaluate Efficacy of Adjuvant Chemotherapy between S-1 and UFT for Locally Advanced Squamous Cell Carcinoma of the Head and Neck: Phase III Study
Trial Start Date		2006-04-01
Trial Completion Date		2012-03-31 (estimated)
Registered in ClinicalTrials.gov		NCT00336947
Date Submitted to PDQ		2006-04-18
Information Last Verified		2008-12-28

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