Surgery With or Without Combination Chemotherapy in Treating Patients With Stomach Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002615
First received: November 1, 1999
Last updated: December 18, 2013
Last verified: August 2001
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not known whether receiving chemotherapy before surgery may be more effective than surgery alone in treating patients with stomach cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery plus combination chemotherapy with surgery alone in treating patients with stomach cancer.


Condition Intervention Phase
Gastric Cancer
Drug: cisplatin
Drug: epirubicin hydrochloride
Drug: fluorouracil
Procedure: conventional surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A RANDOMISED, CONTROLLED TRIAL OF PRE- AND POST-OPERATIVE CHEMOTHERAPY IN PATIENTS WITH OPERABLE GASTRIC CANCER

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 500
Study Start Date: June 1994
Study Completion Date: December 2003
Detailed Description:

OBJECTIVES:

  • 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.

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.

PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study within 4 years.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002615

Locations
United Kingdom
Epsom General Hospital
Epsom, Surrey, United Kingdom, KT18 7EG
Sponsors and Collaborators
Medical Research Council
Investigators
Study Chair: William H. Allum, MD Royal Marsden NHS Foundation Trust
  More Information

Additional Information:
Publications:
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.

ClinicalTrials.gov Identifier: NCT00002615     History of Changes
Other Study ID Numbers: CDR0000063914, MRC-ST02, EU-94035
Study First Received: November 1, 1999
Last Updated: December 18, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II gastric cancer
stage III gastric cancer
adenocarcinoma of the stomach

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Cisplatin
Epirubicin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014