Randomized Trial of Treatment Strategy for Chemotherapy in Colorectal Cancer, FFCD 2000-05
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 570
- 试验地点
- 2
- 主要终点
- Progression-free survival after two lines of chemotherapy, defined as the time duration from randomization until progression after two lines of chemotherapy or death whatever the cause in the absence of progression or last-follow-up
研究概览
简要总结
The standard treatment of metastatic colorectal cancer is based on systemic chemotherapy. Several effective drugs are currently available and can be administered either sequentially or in combination. Most patients receive 2 or 3 lines of chemotherapy. The aim of this randomized trial is to evaluate the potential benefit of a bitherapy with 5-fluorouracil (5-FU) and oxaliplatin as first line chemotherapy compared with a sequential chemotherapy with 5-FU alone as first line chemotherapy followed by the combination of 5-FU with oxaliplatin in case of progressive disease, in terms of progression-free survival and overall survival in patients with advanced colorectal cancer.
详细描述
Background:
The addition of oxaliplatin and irinotecan to 5-FU improves tumor response rate and progression-free survival in patients with advanced colorectal cancer compared with 5-FU alone, but increases toxicity. It is not clear whether such combination therapies (5-FU+oxaliplatin or 5-FU+irinotecan) should be systematically used as first line treatment or as second line treatment after 5-FU failure.
Design: open-label, multicentric, randomized trial
Aim: The main objective of this multiline strategy trial was to compare two 5-FU based regimens with or without the addition of oxaliplatin to 5-FU in the first line setting in terms of progression-free survival after two lines of chemotherapy in patients with metastatic colorectal cancer.
Treatment compared:
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
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed metastatic colorectal adenocarcinoma
- •Unresectable metastasis
- •Bidimensionally measurable disease (World Health Organization [WHO] criteria)
- •WHO performance status of 2 or less
- •Adequate hematologic functions (neutrophil count, at least 1500 per cubic millimeter; and platelet count, at least 100,000 per cubic millimetre)
- •Adequate renal function (serum creatinine, less than 125 micromol per liter)
- •Adequate liver function (bilirubin, not more than 5 times the upper limit of normal)
- •No previous chemotherapy other than previous adjuvant chemotherapy or concomitant chemoradiotherapy with 5-fluorouracil and leucovorin for the treatment of the primary tumor completed at least 6 months before inclusion
- •Signed written inform consent
- •Quality of life questionnaire (QLQ C-30) filled out
排除标准
- •Pregnant or breast - feeding women
- •Impossibility of regular follow-up for psychological, social or geographical reason
- •Severe cardiac, respiratory, renal or hepatic failure
- •Active coronary heart disease
- •Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study
- •Central nervous system metastases
- •Past history of second malignancies
- •Another investigational drug
- •Chronic inflammatory bowel disease
- •Previous chemotherapy with irinotecan or oxaliplatin based regimens
结局指标
主要结局
Progression-free survival after two lines of chemotherapy, defined as the time duration from randomization until progression after two lines of chemotherapy or death whatever the cause in the absence of progression or last-follow-up
次要结局
- Secondary surgery
- Response rate
- Progression-free survival after the first and the third line of chemotherapy
- Safety
- Overall survival
- Quality of life
- Costs