Trial of Adjuvant Chemotherapy for Gastric Cancer

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase III randomized study designed to evaluate the efficacy of mitomycin, doxifluridine, and cisplatin compared to mitomycin and doxifluridine.

• 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

• 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: ECOG 0-2

• Adequate bone marrow function (WBC ≥ 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, AST/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 CT

• Systemic disease which interfere the administration of chemotherapy

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