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Completed

NCT Number: NCT02849158

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Curie, Paris, Île-de-France Region, France

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About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biopsy

Other

Rectoscopy with biopsy

Primary outcomes

  1. Proteomic level evaluation in intra-tumor fibroblast

    Time frame: 3 years

    Proteomic level is assessed before and after radiochemotherapy using SILAC technic (Stable Isotope Labeling by Amino acids in Cell culture)

Secondary outcomes

  1. Study of fibroblast impact on colorectal tumor cells (in vitro)

    Time frame: 3 years

    In vitro analysis including tumor cells characteristics: proliferation, invasive potential, stem cells phenotype).

Other outcomes

  1. Metastatic spread evaluation

    Time frame: 3 years

    On a mouse model of orthotopic rectal cancer, assessment of the potential and metastatic tumor growth

  2. Outcomes 1 to 3 correlation with histological response after RT-CT

    Time frame: 3 years

    Histological response after RT-CT assessed according to the tumor regression grading - Dworak 1997

  3. Disease-free survival

    Time frame: 5 years

    Disease-free Survival assessment

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Registry information

Official study title

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

Acronym: FibroRect

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Jul 29, 2016
Registry last updated
Dec 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.