Trial of Adjuvant Chemotherapy for Gastric Cancer

Asan Medical Center855 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

855

Conditions

Stomach Cancer

Interventions

Mitomycin, doxifluridine and cisplatinDRUG

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)

Mitomycin and doxifluridineDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 69 Years

Medical Language ↔ Plain English

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

Locations (1)

Asan Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Relapse-free Survival Rate

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.

Time frame: 3 years

Secondary Outcomes

Overall Survival Rate

Overall survival rate at 3 years was defined as the proportion of patients who were alive at 3 years after surgery.

Time frame: 3 years

Number of Patients With Adverse Events

Per National Cancer Institute Common Toxicity Criteria version 2.0, up to 3 years

Time frame: Up to 3 years

Data from ClinicalTrials.gov

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