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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02849158

Acronym

FibroRect

Enrollment

Registered

2016-07-29

Start date

2017-06-09

Completion date

2023-06-30

Last updated

2023-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectum Adenocarcinoma

Keywords

Rectoscopy, Proctectomy, Fibroblasts

Brief summary

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

Detailed 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 .

Interventions

OTHERBiopsy

Rectoscopy with biopsy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Other

Measure	Time frame	Description
Metastatic spread evaluation	3 years	On a mouse model of orthotopic rectal cancer, assessment of the potential and metastatic tumor growth
Outcomes 1 to 3 correlation with histological response after RT-CT	3 years	Histological response after RT-CT assessed according to the tumor regression grading - Dworak 1997
Disease-free survival	5 years	Disease-free Survival assessment

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026