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

Institut Curie

Status: Completed

Conditions: Rectum Adenocarcinoma

Treatments: Other: Biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT02849158

IC 2015-12

Details and patient eligibility

About

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

Full description

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 .

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Middle rectum adenocarcinoma Tumor(T)x Node (N)+ or T3 /T4 N0 or N+
2. Classification done on pelvic Magnetic Resonance Imaging (MRI) and rectal ultrasonography
3. Age ≥ 18
4. No contraindication to treatment with capecitabine
5. Able to receive radiotherapy 50 Grays in 5 weeks
6. No contraindication for surgery after chemoradiotherapy which will be 8 to 10 weeks after completion of chemoradiotherapy
7. Patient or legal representative provided with information and signature of informed consent

Exclusion criteria

1. High rectum adenocarcinoma
2. Contraindication to rectal biopsy: including anti-coagulants or anti-platelet agents (vitamin K antagonists, clopidogrel, aspirin > 160 grams) that cannot be interrupted
3. Pregnant woman or breastfeeding
4. Persons deprived of their liberty, or under guardianship
5. Impossibility of undergoing the trial's medical follow-up for geographical, social or psychological reasons.
6. Patient already included in another therapeutic trial with an experimental medication during the realization of protocol biopsies and surgery
7. Patient not covered by health insurance

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Biopsy

Experimental group

Description:

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.

Treatment:

Other: Biopsy