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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if surgery alone or surgery combined with chemotherapy is more effective in treating stomach cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have stage II, stage III, or stage IV stomach cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Calcium; Fluorouracil; Leucovorin; Levoleucovorin

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven stage II-IV adenocarcinoma of the stomach including cardia carcinoma types II and III

• Locally resectable disease

• No distant metastases except M1 lymph nodes

• No evidence of peritoneal carcinomatosis

• Free tumor cells in lavage at laparoscopy allowed

• No uncontrolled bleeding of the primary tumor

• No gastric outlet syndrome or complete tumor stenosis that would require total parenteral nutrition

PATIENT CHARACTERISTICS:

Age:

• 18 to 69

Performance status:

• WHO 0-1

Life expectancy:

• Not specified

Hematopoietic:

• WBC greater than 4,000/mm^3

• Absolute neutrophil count greater than 2,000/mm^3

• Platelet count greater than 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.25 times upper limit of normal (ULN)

• Prothrombin rate at least 70%

Renal:

• Creatinine no greater than 1.25 times ULN

• Creatinine clearance greater than 60 mL/min

Cardiovascular:

• No prior atrial or ventricular arrhythmias

• No prior congestive heart failure

• No myocardial infarction within the past 6 months

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other prior or concurrent neoplasm except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix

• No active infection

• No allergy to protocol drugs

• No dementia or significantly altered mental status

• No other serious medical condition that would prevent compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No filgrastim (G-CSF) within 48 hours prior to chemotherapy

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy

Surgery:

• See Disease Characteristics

• No prior stent implantation

• No prior laser therapy