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Clinical Trials (PDQ®)

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.

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosedAny ageOtherMRC-ST02
EU-94035, NCT00002615

Objectives

  1. 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.
  2. Determine the effect of perioperative chemotherapy on the resectability of gastric cancer in these patients.

Entry Criteria

Disease Characteristics:

  • 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

Prior/Concurrent Therapy:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • See Disease Characteristics

Patient Characteristics:

Age:

  • Any age

Performance status:

  • WHO 0-1

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Creatinine clearance greater than 60 mL/min

Cardiovascular:

  • No clinical evidence of uncontrolled angina pectoris, cardiac failure, or significant uncontrolled cardiac arrhythmia

Other:

  • No medical contraindication to study therapy
  • No other prior malignancy except nonmelanomatous skin cancer or carcinoma in situ of the cervix
  • Not pregnant

Expected Enrollment

500

A 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).

  • 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.

Published Results

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

William Allum, MD, Protocol chair
Ph: 44-207-808-2782
Email: william.allum@rmh.nhs.uk

Registry Information
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.

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