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

Study Overview
=================
Brief Summary
-----------------
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.

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.

Official Title
-----------------
A RANDOMISED, CONTROLLED TRIAL OF PRE- AND POST-OPERATIVE CHEMOTHERAPY IN PATIENTS WITH OPERABLE GASTRIC CANCER

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Drug: cisplatin
* Drug: epirubicin hydrochloride
* Drug: fluorouracil
* Procedure: conventional surgery


Participation Criteria
=================
Eligibility 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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|nan|
|Drug: epirubicin hydrochloride|nan|
|Drug: fluorouracil|nan|
|Procedure: conventional surgery|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage II gastric cancer, stage III gastric cancer, adenocarcinoma of the stomach