Randomized Phase III Trial Comparing Adjuvant Oral UFT/LV to 5-FU/l-LV in Stage III Colorectal Cancer (JCOG-0205-MF)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,101
- 试验地点
- 48
- 主要终点
- Disease-free survival
研究概览
简要总结
To evaluate the clinical effectiveness of oral UFT/LV comparing 5-FU/l-LV as adjuvant therapy for stage III colorectal cancer.
详细描述
Oral fluoropyrimidines are widely used in practice for postoperative adjuvant chemotherapy for curatively resected colorectal cancer in Japan. In order to evaluate a clinical benefit of oral anticancer drugs in adjuvant chemotherapy, we conducted randomized controlled trial comparing the oral combination chemotherapy, UFT+LV, to the standard intravenous combination chemotherapy, 5-FU+l-LV, in stage III colorectal cancer.
UFT+LV: UFT 300mg/m2/day and LV 75mg/day, orally for 28days with 7days rest, repeated five times every 5 weeks.
5-FU+l-LV: 5-FU 500mg/m2, l-LV 250mg/m2, weekly administration for 6 times, repeated three times every 8 weeks.
Primary endpoints are disease-free survival and secondary endpoints are overall survival and adverse event rate.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically proved colorectal cancer (either adenocarcinoma, mucinous carcinoma, or signet-ring cell carcinoma).
- •Tumor is mainly located in between cecum and upper rectum, excluding that invades to lower rectum.
- •Stage III cancer by General Rules for Clinical and Pathological Studies on Cancer of the Colon, Rectum and Anus (6th ed.), excluding si(ai), n(-), M(-).
- •No synchronous colorectal cancer which invade muscularis propria or deeper.
- •Tumor resection with D2 or D3 lymph node dissection was performed.
- •Pathological determination of curability of tumor resection is cur A.
- •Age at registration is above 20 and below 75 years old.
- •ECOG Performance status is 0 or
- •No prior chemotherapy or radiation therapy.
- •Intake of normal diet and oral drugs is possible.
- •Major organ function is preserved. WBC>=3,000/mcl, PLT>=100,000/mcl, GOT<=100 IU/L, GPT<=100 IU/L, T.Bil <=2.0 mg/dl, Cr<=1.5 mg/dl
- •Adjuvant chemotherapy can be started within 9 weeks after surgery.
- •Written informed consent is taken.
排除标准
- •Active co-existing malignancy （synchronous or metachronous malignancy whose disease free period is within 5 years). Carcinoma in situ is eligible.
- •Severe postoperative complications which do not resolve until registration.
- •There is following complication. insulin-controlling or uncontrollable diabetes mellitus, uncontrollable hypertension, myocardial infarction within six month or unstable angina pectoris, liver cirrhosis, interstitial pneumonia, pulmonary fibrosis, severe emphysema
- •Pregnant or breast-feeding woman.
- •Difficult to participate with the trial, having mental disorder or psychiatric symptoms.
- •Judged to be inappropriate to register.
研究组 & 干预措施
1
5-FU/l-LV
干预措施: 5FU+l-leucovorin (Drug)
2
UFT/LV
干预措施: UFT+Leucovorin (Drug)
结局指标
主要结局
Disease-free survival
时间窗: during the study conduct
次要结局
- Rate of adverse event(during the study conduct)
- Overall survival(during the study conduct)
研究者
Haruhiko Fukuda
JCOG Data Center
Japan Clinical Oncology Group