Trial of Adjuvant Chemotherapy for Gastric Cancer

Asan Medical Center

Status and phase: Completed; Phase 3

Conditions: Stomach Cancer

Treatments: Drug: Mitomycin, doxifluridine and cisplatin; Drug: Mitomycin and doxifluridine

Study type: Interventional

Funder types: Other

Identifiers

NCT00296335

AMC-ONCGI-0204

Details and patient eligibility

About

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

Full 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.

Enrollment: 855 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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855 participants in 2 patient groups

Mitomycin and doxifluridine

Active Comparator group

Description:

Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84)

Treatment:

Drug: Mitomycin and doxifluridine

Mitomycin, doxifluridine and cisplatin

Experimental group

Description:

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)

Treatment:

Drug: Mitomycin, doxifluridine and cisplatin