Association Between the Composition of the Intestinal Microbiota Before Treatment and the Tumor Response After Induction Chemotherapy Followed or Not by Neo-adjuvant Radio-chemotherapy in Locally Advanced Rectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Gut microbiota description at T0
研究概览
简要总结
This is an observational, single-centre study (RIPH3) for patients with rectal cancer soon to be treated with chemotherapy (+/- neo-adjuvant radio-chemotherapy) looking at the relationship between the composition of the gut microbiota before treatment and the tumour response after chemotherapy +/- radio-chemotherapy
详细描述
Main objective: The main objective is to test the association between :
- the gut microbiota assessed from a stool sample before the start of neoadjuvant treatment of patients (T0) on the one hand, and
- complete histological response assessed on the surgical resection specimen in patients with histologically proven stage II and III rectal tumours treated with neo-adjuvant chemotherapy followed or not by Cap50 radiochemotherapy before surgery.
Primary endpoint: The primary endpoint will be complete histological response assessed on the surgical specimen after the neoadjuvant therapy regimen. This assessment will be performed according to the usual standards and blinded to any information on the gut microbiota and on the content of short-chain fatty acids and tryptophan derivatives.
Secondary objectives:
- To explore the profile of gut microbiota composition and short-chain fatty acid content in the two groups of patients (complete histological response or not), assessed before any treatment (T0).
- To assess the changes in the composition of the intestinal flora and the content of short chain fatty acids following treatment with induction chemotherapy (T1), then preoperative radiochemotherapy (T2) if applicable, by comparison of the preoperative sample with the initial sample (T0).
- Assess the association between these taxonomic and metabolic changes (T1-T0, T2-T0) on the one hand and the histological response on the other.
- To evaluate the association between the profile of the composition of the intestinal microbiota and the content of short-chain fatty acids, as well as calprotectin (a reliable and sensitive non-invasive marker of intestinal inflammation) assessed before any treatment (T0) on the one hand, and the occurrence of toxicity during treatment, in particular digestive toxicity.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Histologically proven stage II and III adenocarcinoma of the lower and middle rectum
- •Patient undergoing preoperative treatment with induction chemotherapy (Folfirinox) followed or not by radio-chemotherapy of the Cap50 type
- •Male or female patient aged 18 years or older
- •Normal weight, overweight or moderately obese (BMI between 18.5 and 34.9)
- •Patient residing in the Lille metropolitan area
- •Patient affiliated to a French social protection scheme
- •Patient having given his non-opposition
排除标准
- •History of other concurrent cancers
- •Presence of an intestinal (internal or external) or external urinary diversion
- •Uncooperative patient for geographical, family, social or psychological reasons
- •Limited legal capacity or legal incapacity
研究组 & 干预措施
Person with rectal cancer
People with locally advanced rectal cancer who are to receive induction chemotherapy with FLOFIRINOX followed or not by neo-adjuvant radio-chemotherapy of the Cap50 type.
干预措施: Stool collection (Procedure)
结局指标
主要结局
Gut microbiota description at T0
时间窗: at baseline
gut microbiota assessed from a stool sample before the start of neoadjuvant treatment of patients (T0) Measurement of gut microbiota composition at T0 by high-throughput sequencing of the 16S subunit of bacterial ribosomes
histological response according to Ryan classification
时间窗: after surgery, an average of 8 months after inclusion
complete histological response assessed on the surgical resection specimen in patients with histologically proven stage II and III rectal tumours treated with neo-adjuvant chemotherapy followed or not by Cap50 radiochemotherapy before surgery and according to Ryan classification. TRG (TRG0-TRG3) TRG 3: extensive residual cancer with no evident tumor regression (poor or not response
次要结局
未报告次要终点