Surgery With or Without Combination Chemotherapy in Treating Patients With Stomach Cancer
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| ClinicalTrials.gov Identifier: NCT00002615 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : December 19, 2013
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Gastric Cancer | Drug: cisplatin Drug: epirubicin hydrochloride Drug: fluorouracil Procedure: conventional surgery | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 500 participants |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
| Official Title: | A RANDOMISED, CONTROLLED TRIAL OF PRE- AND POST-OPERATIVE CHEMOTHERAPY IN PATIENTS WITH OPERABLE GASTRIC CANCER |
| Study Start Date : | June 1994 |
| Actual Study Completion Date : | December 2003 |
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002615
| United Kingdom | |
| Epsom General Hospital | |
| Epsom, Surrey, United Kingdom, KT18 7EG | |
| Study Chair: | William H. Allum, MD | Royal Marsden NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT00002615 |
| Other Study ID Numbers: |
CDR0000063914 MRC-ST02 EU-94035 |
| First Posted: | January 27, 2003 Key Record Dates |
| Last Update Posted: | December 19, 2013 |
| Last Verified: | August 2001 |
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stage II gastric cancer stage III gastric cancer adenocarcinoma of the stomach |
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Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Fluorouracil Epirubicin Antineoplastic Agents |
Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |