NCT01437618已完成不适用
FOLFOXIRI Plus Bevacizumab as First-line Treatment for BRAF V600E Mutant Metastatic Colorectal Cancer: a Prospective Evaluation
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Progression-Free Survival
研究概览
简要总结
The purpose of this study is to prospectively verify if FOLFOXIRI plus bevacizumab as first-line treatment could be considered a promising approach to improve the outcome of BRAF mutant metastatic colorectal cancer patients
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Histologically confirmed colorectal adenocarcinoma;
- •Availability of formalin-fixed paraffin embedded tumor block from primary and/or metastasis;
- •BRAF V600E mutant status of primary colorectal cancer and/or related metastasis;
- •Unresectable and measurable metastatic disease according to RECIST criteria;
- •Male or female, aged > 18 years and < 75 years;
- •ECOG PS < 2 if aged < 71 years;
- •ECOG PS = 0 if aged 71-75 years;
- •Life expectancy of more than 3 months;
- •Adequate haematological function: ANC ≥ 1.5 x 10^9/L; platelets ≥ 100 x 10^9/L, Hb ≥ 9 g/dL;
- •Adequate liver function: serum bilirubin ≤ 1.5 x ULN; alkaline phosphatase and transaminases ≤ 2.5 x ULN (in case of liver metastases ≤ 5 x ULN);
- •Serum creatinine ≤ 1.5 x ULN;
- •Previous adjuvant chemotherapy is allowed if more than 12 months have elapsed between the end of adjuvant therapy and first relapse;
- •At least 6 weeks from prior extended radiotherapy and 4 weeks from surgery;
- •Written informed consent to experimental treatment and molecular analyses.
排除标准
- •Presence or history of CNS metastasis;
- •Serious, non-healing wound, ulcer, or bone fracture;
- •Evidence of bleeding diathesis or coagulopathy;
- •Uncontrolled hypertension;
- •Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (CVA) (≤6 months before treatment start), myocardial infarction (≤ 6 months before treatment start), unstable angina, NYHA ≥ grade 2 chronic heart failure (CHF), uncontrolled arrhythmia;
- •Current or recent (within 10 days prior to study treatment start) ongoing treatment with anticoagulants for therapeutic purposes;
- •Chronic, daily treatment with high-dose aspirin (>325 mg/day);
- •Symptomatic peripheral neuropathy ≥ 2 grade NCIC-CTG criteria;
- •Active uncontrolled infections;
- •Treatment with any investigational drug within 30 days prior to enrolment;
- •Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of curatively treated basal and squamous cell carcinoma of the skin or in situ cancer of the cervix;
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start;
- •Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome;
- •Fertile women (< 2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception.
研究组 & 干预措施
BRAF mutant mCRC
干预措施: FOLFOXIRI plus bevacizumab (Drug)
结局指标
主要结局
Progression-Free Survival
时间窗: About 24-30 months (From treatment initiation to evidence of progression or death from any cause)
次要结局
未报告次要终点
研究者
Alfredo Falcone
Professor Alfredo Falcone
Azienda Ospedaliero, Universitaria Pisana
研究点 (1)
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