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Phase III Randomized Study of Epirubicin, Cisplatin, and Fluorouracil (ECF) Before and After Resection Versus Resection Alone in Patients With Resectable Stage II or III Adenocarcinoma of the Stomach
Alternate Title Surgery With or Without Combination Chemotherapy in Treating Patients With Stomach Cancer
Objectives
Entry Criteria Disease Characteristics:
Prior/Concurrent Therapy: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Patient Characteristics: Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
Expected Enrollment 500A total of 500 patients will be accrued for this study within 4 years. Outline This is a randomized, multicenter study. Patients are stratified by center and performance status (0 vs 1).
Quality of life is assessed at baseline, at completion of study therapy, and then every 6 months for 2 years. Patients are followed every 6 months for 2 years and then annually thereafter. Published ResultsCunningham D, Allum WH, Stenning SP, et al.: Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med 355 (1): 11-20, 2006.[PUBMED Abstract] Cunningham D, Allum WH, Stenning SP, et al.: Perioperative chemotherapy in operable gastric and lower oesophageal cancer: final results of a randomised, controlled trial (the MAGIC trial, ISRCTN 93793971). [Abstract] J Clin Oncol 23 (Suppl 16): A-4001, 308s, 2005. Allum W, Cunningham D, Weeden S: Perioperative chemotherapy in operable gastric and lower oesophageal cancer: a randomised, controlled trial (the MAGIC trial, ISRCTN 93793971). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-998, 249, 2003. Trial Lead Organizations Medical Research Council Clinical Trials Unit
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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