Clinical trial · Observational
Association Between the Composition of the Intestinal Microbiota and Tumor Response in Locally Advanced Rectal Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of eligible patients
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Rectum | Malignant Rectal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stool collection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Person with rectal cancer
- description
- 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.
- interventionNames
- Procedure: Stool collection
Primary outcomes (2)
- measure
- Gut microbiota description at T0
- timeFrame
- at baseline
- description
- 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
- measure
- histological response according to Ryan classification
- timeFrame
- after surgery, an average of 8 months after inclusion
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available