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Alternate Title Phase III Randomized Study of S-1 and Cisplatin Versus Fluorouracil and Cisplatin in Patients With Unresectable Locally Advanced or Metastatic Gastric Cancer
Trial Description Drugs used in chemotherapy, such as S-1, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether S-1 and cisplatin are more effective than fluorouracil and cisplatin in treating gastric cancer. This randomized phase III trial is studying S-1 and cisplatin to see how well they work compared to fluorouracil and cisplatin in treating patients with locally advanced or metastatic gastric cancer that cannot be removed by surgery. 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 receive a 1- to 3-hour infusion of cisplatin in week 1. They will also receive S-1 by mouth twice a day in weeks 1-3. Treatment with cisplatin and S-1 may repeat every 4 weeks for up to six courses. Patients will then receive S-1 alone twice a day for 3 weeks. Treatment with S-1 alone may repeat every 4 weeks for as long as benefit is shown. Patients in group two will receive a 1- to 3-hour infusion of cisplatin and a 5-day continuous infusion of fluorouracil in week 1. Treatment with cisplatin and fluorouracil may repeat every 4 weeks for up to six courses. Patients will then receive a 5-day continuous infusion of fluorouracil alone every 4 weeks for as long as benefit is shown. Quality of life will be assessed periodically. After finishing treatment, patients will be evaluated every 2 months for up to 5 years. 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 Taiho Pharma U.S.A., Incorporated
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