A Phase III Randomized Controlled Trial of Adjuvant Chemotherapy for Advanced Gastric Adenocarcinoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 855
- 试验地点
- 1
- 主要终点
- Relapse-free Survival Rate
研究概览
简要总结
This is a phase III randomized study designed to evaluate the efficacy of mitomycin, doxifluridine, and cisplatin compared to mitomycin and doxifluridine.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Mitomycin and doxifluridine
Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84)
干预措施: Mitomycin and doxifluridine (Drug)
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)
干预措施: Mitomycin, doxifluridine and cisplatin (Drug)
结局指标
主要结局
Relapse-free Survival Rate
时间窗: 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.
次要结局
- Overall Survival Rate(3 years)
- Number of Patients With Adverse Events(Up to 3 years)
研究者
Yoon-Koo Kang
Professor
Asan Medical Center