Trial of Adjuvant Chemotherapy for Gastric Cancer

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to evaluate the efficacy of the intraperitoneal chemotherapy with early mitomycin administration and adding cisplatin to prolonged treatment with doxifluridine compared to mitomycin plus doxifluridine in resected advanced gastric cancer.

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

Details

• Lead Sponsor: Asan Medical Center
• Collaborators: Hallym University Medical Center; Ulsan University Hospital
• Treatments: Cisplatin; Doxifluridine; Floxuridine; Mitomycin; Mitomycins

Criteria

Inclusion Criteria:

• Pathologically proven gastric adenocarcinoma

• Grossly serosa invasion of primary tumor is suspicious

• Curative resection was done

• Stage II, IIIA, IIIB, IV (including T4, lesions or N3, but excluding M1 lymph node metastasis)

• Age: 18-69 years old

• Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2

• Adequate bone marrow function (white blood cell counts ≥ 4,000/ul, platelet count ≥ 100,000/ul, hemoglobin ≥ 10 g/dl)

• Adequate renal function (serum creatinine≤ 1.5)

• Adequate liver function (serum bilirubin ≤1.5 mg/dl, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x normal upper limit)

• Written informed consent was signed by the patient

Exclusion Criteria:

• Previous chemotherapy or radiotherapy

• Active ongoing infection which antibiotic treatment is needed

• Pregnant or lactating women

• Psychosis or convulsion disorder

• Ascites in preoperative abdomen computed tomography (CT)

• Systemic disease which interfere the administration of chemotherapy

• Postoperative pathologic stage IA, IB

• Postoperative pathology indicates that resection margin is involved

• Previous history of other malignancy except cured non-malignant skin cancer and uterine cervical cancer in situ