Fibroblast Before and After Neoadjuvant Chemo-radiotherapy in Patient With Locally Advanced Rectal Adenocarcinoma

Study Overview
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Brief Summary
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Single center interventional study to explore activity of fibroblasts in the tumor and away in the healthy rectal tissue.

Detailed Description
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Patients included in the trial will have new biopsy performed before starting the Radiation Therapy and Chemotherapy (RT-CT). These biopsies will study the activity of fibroblasts in the tumor and away in the healthy rectal tissue. Within 8 to 10 weeks after the end of RT-CT, patients will have cancer surgery by proctectomy (with complete removal of the meso-rectum). On the resection specimen, new samples will be taken at the level of the tumor and away from the rectum.This study is single center interventional exploratory .

Official Title
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Interest in Studying Fibroblast Before and After Neoadjuvant Chemo-radiotherapy in Patient With Locally Advanced Rectal Adenocarcinoma : Exploratory Study

Conditions
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Rectum Adenocarcinoma

Intervention / Treatment
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* Other: Biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Middle rectum adenocarcinoma Tumor(T)x Node (N)+ or T3 /T4 N0 or N+ Classification done on pelvic Magnetic Resonance Imaging (MRI) and rectal ultrasonography Age ≥ 18 No contraindication to treatment with capecitabine Able to receive radiotherapy 50 Grays in 5 weeks No contraindication for surgery after chemoradiotherapy which will be 8 to 10 weeks after completion of chemoradiotherapy Patient or legal representative provided with information and signature of informed consent Exclusion Criteria: High rectum adenocarcinoma Contraindication to rectal biopsy: including anti-coagulants or anti-platelet agents (vitamin K antagonists, clopidogrel, aspirin > 160 grams) that cannot be interrupted Pregnant woman or breastfeeding Persons deprived of their liberty, or under guardianship Impossibility of undergoing the trial's medical follow-up for geographical, social or psychological reasons. Patient already included in another therapeutic trial with an experimental medication during the realization of protocol biopsies and surgery Patient not covered by health insurance

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biopsy<br>Patients will have new biopsy before starting RT-CT and samples will be taken on rectum surgery at the level of the tumor and away from the rectum. | Other: Biopsy<br>* Rectoscopy with biopsy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proteomic level evaluation in intra-tumor fibroblast | Proteomic level is assessed before and after radiochemotherapy using SILAC technic (Stable Isotope Labeling by Amino acids in Cell culture) | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study of fibroblast impact on colorectal tumor cells (in vitro) | In vitro analysis including tumor cells characteristics: proliferation, invasive potential, stem cells phenotype). | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rectoscopy, Proctectomy, Fibroblasts