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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2024
  • participants needed
    15
  • sponsor
    Institut Curie
Updated on 22 February 2021

Summary

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

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 .

Details
Condition Rectum Adenocarcinoma
Treatment biopsy
Clinical Study IdentifierNCT02849158
SponsorInstitut Curie
Last Modified on22 February 2021

Eligibility

Yes No Not Sure

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
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