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. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.
Surgery With or Without Combination Chemotherapy in Treating Patients With Stomach Cancer. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.
Basic Trial Information
|Phase III||Treatment||Closed||Any age||Other||MRC-ST02|
- Compare the survival and quality of life of patients with resectable stage II or III adenocarcinoma of the stomach treated with epirubicin, cisplatin, and fluorouracil before and after resection vs resection alone.
- Determine the effect of perioperative chemotherapy on the resectability of gastric cancer in these patients.
- Histologically proven resectable stage II or III adenocarcinoma of the stomach
- No evidence of locally inoperable or distant metastases on chest x-ray and any combination of abdominal ultrasound, CT scan, or laparoscopy
- Not specified
- No prior chemotherapy
- Not specified
- No prior radiotherapy
- See Disease Characteristics
- Any age
- WHO 0-1
- Not specified
- Not specified
- Creatinine clearance greater than 60 mL/min
- No clinical evidence of uncontrolled angina pectoris, cardiac failure, or significant uncontrolled cardiac arrhythmia
- No medical contraindication to study therapy
- No other prior malignancy except nonmelanomatous skin cancer or carcinoma in situ of the cervix
- Not pregnant
A total of 500 patients will be accrued for this study within 4 years.
This is a randomized, multicenter study. Patients are stratified by center and performance status (0 vs 1).
- Arm I: Patients undergo radical total gastrectomy or radical subtotal distal gastrectomy, at the discretion of the surgeon, with perigastric lymph node dissection. Patients also may undergo lymphadenectomy at the discretion of the surgeon. At the beginning of the laparotomy, a pre-aortic, infra-colic node is sampled for staging purposes and frozen sections are examined during surgery. Patients who are found to have metastatic disease undergo palliative resection at the discretion of the surgeon and postoperative chemotherapy at the discretion of the oncologist.
- Arm II: Patients receive fluorouracil (5-FU) IV continuously for 3 weeks and cisplatin IV over 4 hours (beginning 4 hours after initiation of 5-FU infusion) and epirubicin IV on day 1 (ECF). Treatment continues every 3 weeks for 3 courses. Within 6 weeks after completion of course 3 and when blood counts recover, patients undergo resection as in arm I. Beginning within 4-6 weeks after surgery, patients receive 3 additional courses of ECF.
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.
Cunningham 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 Contact Information
Trial Lead Organizations
Medical Research Council Clinical Trials Unit
|Official Title||A RANDOMISED, CONTROLLED TRIAL OF PRE- AND POST-OPERATIVE CHEMOTHERAPY IN PATIENTS WITH OPERABLE GASTRIC CANCER|
|Trial Start Date||1994-06-01|
|Registered in ClinicalTrials.gov||NCT00002615|
|Date Submitted to PDQ||1994-06-01|
|Information Last Verified||2001-08-24|
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.