Trial of Adjuvant Chemotherapy for Gastric Cancer

Phase 3

Completed

Interventions: Drug: Mitomycin and doxifluridine
Drug: Mitomycin, doxifluridine and cisplatin

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

Detailed Description: Stomach cancer is the most common cancer in Korea and one of the major health problems worldwide. The most effective treatment for gastric cancer is curative surgical resection of primary tumor. However, a substantial number of patients eventually die of recurrences after curative resection. A number of randomized trials investigating the role of adjuvant chemotherapy have been conducted. However, the efficacy of adjuvant chemotherapy is still controversial and varied between Western and Asian trials. Meta-analysis of Western trials didn't demonstrate the benefit of adjuvant chemotherapy after curative resection. Conversely, some Asian studies have demonstrated the efficacy of adjuvant chemotherapy after curative resection. In a previous study, mitomycin plus tegafur prolonged the survival in resected gastric cancer compared to no treatment.

This study is designed to evaluate the efficacy of mitomycin, cisplatin and prolonged treatment with doxifluridine compared to mitomycin plus doxifluridine.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Mitomycin and doxifluridine	Mitomycin and doxifluridine	Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84)
Mitomycin, doxifluridine and cisplatin	Mitomycin, doxifluridine and cisplatin	Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)

Primary Outcome Measures

Name	Time	Method
Relapse-free Survival Rate	3 years	Relapse-free survival at 3 years was defined as the proportion of patients who did not show an evidence of disease recurrence after 3 years of surgery. Relapse was defined as any new tumor lesion.

Secondary Outcome Measures

Name	Time	Method
Overall Survival Rate	3 years	Overall survival rate at 3 years was defined as the proportion of patients who were alive at 3 years after surgery.
Number of Patients With Adverse Events	Up to 3 years	Per National Cancer Institute Common Toxicity Criteria version 2.0, up to 3 years