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

Primary Purpose

Rectum Adenocarcinoma

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biopsy
Sponsored by
Institut Curie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Rectum Adenocarcinoma focused on measuring Rectoscopy, Proctectomy, Fibroblasts

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Institut Curie
  • Institut Curie - Hôpital René Huguenin
  • INSTITUT CURIE - Site Paris

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biopsy

Arm 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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
July 13, 2016
Last Updated
August 16, 2023
Sponsor
Institut Curie
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1. Study Identification

Unique Protocol Identification Number
NCT02849158
Brief Title
Fibroblast Before and After Neoadjuvant Chemo-radiotherapy in Patient With Locally Advanced Rectal Adenocarcinoma
Acronym
FibroRect
Official Title
Interest in Studying Fibroblast Before and After Neoadjuvant Chemo-radiotherapy in Patient With Locally Advanced Rectal Adenocarcinoma : Exploratory Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 9, 2017 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Curie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectum Adenocarcinoma
Keywords
Rectoscopy, Proctectomy, Fibroblasts

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biopsy
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Biopsy
Intervention Description
Rectoscopy with biopsy
Primary Outcome Measure Information:
Title
Proteomic level evaluation in intra-tumor fibroblast
Description
Proteomic level is assessed before and after radiochemotherapy using SILAC technic (Stable Isotope Labeling by Amino acids in Cell culture)
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Study of fibroblast impact on colorectal tumor cells (in vitro)
Description
In vitro analysis including tumor cells characteristics: proliferation, invasive potential, stem cells phenotype).
Time Frame
3 years
Other Pre-specified Outcome Measures:
Title
Metastatic spread evaluation
Description
On a mouse model of orthotopic rectal cancer, assessment of the potential and metastatic tumor growth
Time Frame
3 years
Title
Outcomes 1 to 3 correlation with histological response after RT-CT
Description
Histological response after RT-CT assessed according to the tumor regression grading - Dworak 1997
Time Frame
3 years
Title
Disease-free survival
Description
Disease-free Survival assessment
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascale MARIANI, LDD
Organizational Affiliation
Institut Curie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Curie
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75248
Country
France
Facility Name
Institut Curie - Hôpital René Huguenin
City
Saint-Cloud
State/Province
Ile De France
ZIP/Postal Code
92210
Country
France
Facility Name
INSTITUT CURIE - Site Paris
City
Paris
ZIP/Postal Code
75005
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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