Phase 3 Study of Adjuvant Chemoradiotherapy of Advanced Resectable Rectal Cancer Comparing Modulation of 5-FU With Folinic Acid or With Interferon-alpha
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 796
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
The primary objective was to improve adjuvant 5-FU chemoradiotherapy in resectable rectal cancer. The investigators hypothesis was that modulation of 5-FU by addition of either FA or INF-alpha may increase overall survival.
详细描述
Primary endpoint was overall survival (OS). For sample size estimation the following assumptions were made: The 5-year OS rate of 5-FU was estimated to be 58%. Our intention was to detect an increase in the 5-year OS rate by one of the additives of at least 10% with a power of 80% and a level of significance of 5% in comparison to 5-FU (one-sided). Hypotheses were analyzed as pair wise comparisons between the treatment options. This resulted in a target sample size of 280 patients per group and a total of 840 patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility was defined as potentially curative en-bloc resection (R0) of an adenocarcinoma of the rectum with a lower tumor edge within 12 cm from the anal verge determined by rectoscopy, a pathologic UICC stage II (pT3/4pN0M0) or III (pT1-4pNposM0) with examination of at least 12 lymph nodes, a white blood count ≥ 3,500/µl, a platelet count ≥ 100,000/µl, a ECOG performance status of 0 or 1, and written informed consent.
排除标准
- •Ineligible were patients not fulfilling these criteria or having a history of cancer except for adequately treated superficial basal or squamous cell skin cancer or in situ carcinoma of the cervix, getting previous radio- or chemotherapy, pregnant or nursing women, other having severe concomitant diseases limiting life expectancy or not allowing chemotherapy, and with social conditions not allowing a 5-year follow-up.
研究组 & 干预措施
5-FU
Standard arm Systemic drug administration of 5-FU (intravenous)
干预措施: Folinic Acid, interferon-alpha (Drug)
5-FU + folinic acid
Experimental arm Systemic drug administration of 5-FU + folinic acid (intravenous)
干预措施: Folinic Acid, interferon-alpha (Drug)
5-FU + Interferon-alpha
Experimental arm Systemic drug administration of 5-FU + interferon-alpha (intravenous)
干预措施: Folinic Acid, interferon-alpha (Drug)
结局指标
主要结局
overall survival
时间窗: 5-year
次要结局
- recurrence-free survival(5-year)
- Toxicity (WHO)(5-year)