Predictive Response to Chemotherapy (FOLFOX or FOLFIRI) by ex Vivo Culture 3D Technique in Metastatic Colorectal Cancer: a Preliminary Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 4
- 主要终点
- Number of interpretable chemogram
研究概览
简要总结
Prospective, open labelled, multicenter trial to evaluate the feasibility of ex vivo culture 3D (chemogram obtaining) on biopsies in order to estimate the predictive value of this technique for treatment response in patients treated by two different chemotherapies (FOLFOX or FOLFIRI) for colorectal cancer.
详细描述
The CULTURE 3D study is a prospective, open labelled, multicenter trial. The aim is to evaluate the feasibility of ex vivo culture 3D (chemogram) on biopsies in order to estimate the predictive value of this technique for treatment response in patients treated by two different chemotherapies (FOLFOX or FOLFIRI) for colorectal cancer.
Patients will have biopsies in a metastasis or in the primitive tumor before treatment. The sample will be used for a 3D ex vivo cells culture. A chemogram will be made based on cells proliferation data (Ki67) and apoptosis (M30).
Results from this chemogram will not interfere with the treatment combination choice.
The treatment response will be evaluated by the RECIST assessment and will be then compared to the chemogram.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Aged 18 years old or more
- •Colorectal cancer with synchronous or metachronous metastases
- •Metastasis and/or primitive tumor (in case of synchronous metastases) accessible to biopsy
- •Measurable metastatic disease (echography, CT and/or MRI, PET-FDG)
- •Indication for treatment with a combination including FOLFOX/FOLFIRI associated to an anti VEGF drug (Avastin)
- •No adjuvant chemotherapy for the primitive colorectal cancer and no line of chemotherapy for metastatic disease during the year prior to inclusion.
- •Life expectancy > 3 months (ECOG 0-1-2).
- •Informed and signed consent by the patient.
排除标准
- •Elevation of Carcinoembryonic antigen (CEA) without measurable metastatic disease
- •Medical contraindication to chemotherapy or biotherapy as FOLFOX/FOLFIRI or Avastin.
- •Treatment with FOLFOX/FOLFIRI and biotherapy anti-EGFR (epidermal growth factor receptor)(Erbitux) planned
- •Patient already enrolled in an other clinical trial with another first line of chemotherapy.
- •Pregnant women, breastfeeding or of childbearing age not taking contraceptive
- •Persons deprived of liberty.
- •Subject unable to make follow up schedule
结局指标
主要结局
Number of interpretable chemogram
时间窗: through study completion, an average of 1 year
In ex vivo 3D culture from tumor biopsies, number of interpretable chemogram.
次要结局
- Chemosensitivity evaluated on 3D culture.(through study completion, an average of 1 year)
- Correlation between chemogram results obtained by 3D culture and RECIST 1.1 response assessement.(through study completion, an average of 1 year)
- time to obtain chemogram(through study completion, an average of 1 year)