Stratified and Randomized Multi-center Phase II - to Determine Potential Benefit of Treating Patients With Advanced Colorectal Cancer According to the Intratumoral TS RNA Levels
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Best response to first-line chemotherapy (recist)
研究概览
简要总结
The aim of the study was to evaluate the feasibility of TS determination in a multicenter trial setting using a central facility for measurement and confirm its role as predictive factor for 5-FU treatment in MCRC.
详细描述
Eligible were patients with non-resectable metastasized or recurrent histologically proven CRC with the presence of a reference lesion two-dimensional measurable and accessible for a biopsy.The biopsy was taken from the reference lesion either by surgery during primary tumor resection, by trans-cutaneous true-cut needle biopsy or by trans-anal approach. Intratumoral relative TS mRNA expression levels were determined using samples shipped in RNA-preserving solution or as glass slides after microdissection of tumor cells. An independent company stratified the patients according to ther relative TS mRNA expression level in TS low and TS high followed by randomization to receive either FUFA of Folfiri. Response to chemotherapy was evaluated and documented according to the RECIST criteria after every therapy cycle.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients (>= 18 years) with non-resectable metastasized or recurrent histologically proven CRC with the presence of a reference lesion two-dimensional measurable and accessible for a biopsy
- •a performance status WHO 0-2 (Karnofsky >= 60%)
- •an estimated life expectancy of at least 3 months
- •written informed consent
排除标准
- •patients older than 75 years not fulfilling these criteria
- •brain metastases or a secondary cane
- •a history of a systemic palliative chemotherapy
- •and an adjuvant chemotherapy (within 6 months)
- •pregnant or nursing women
- •a known allergy toward irinotecanhydroclorid or of any ingredients of Campto or other severe medical
- •laboratory and social conditions not allowing chemotherapy and follow-up
研究组 & 干预措施
5-FU
FUFA 5-flurouracil and folinic acid control
干预措施: FUFA (Drug)
Folfiri
5-fluouracil and folinic acid in combination with irinotecan (Folfiri) systemic chemotherapy intensified treatment arm
干预措施: systemic chemotherapy (Drug)
结局指标
主要结局
Best response to first-line chemotherapy (recist)
时间窗: 1 year
Response to chemotherapy was evaluated and documented according to the RECIST criteria after every therapy cycle (every two months).
次要结局
- overall survival, toxicity, treatment related complications, time to progression(3-year)