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

Rectum Adenocarcinoma Clinical Trial

— FibroRect  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02849158
• Other study ID #: IC 2015-12
• Status: Completed
• Phase: N/A
• Start date: June 9, 2017
• Est. completion date: June 30, 2023

Study information

• Verified date: November 2023
• Source: Institut Curie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Rectum Adenocarcinoma

Intervention

Other:
• Biopsy
Rectoscopy with biopsy

Locations

Country	Name	City	State
France	Institut Curie	Paris	Ile De France
France	INSTITUT CURIE - Site Paris	Paris
France	Institut Curie - Hôpital René Huguenin	Saint-Cloud	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Metastatic spread evaluation	On a mouse model of orthotopic rectal cancer, assessment of the potential and metastatic tumor growth	3 years
Other	Outcomes 1 to 3 correlation with histological response after RT-CT	Histological response after RT-CT assessed according to the tumor regression grading - Dworak 1997	3 years
Other	Disease-free survival	Disease-free Survival assessment	5 years
Primary	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)	3 years
Secondary	Study of fibroblast impact on colorectal tumor cells (in vitro)	In vitro analysis including tumor cells characteristics: proliferation, invasive potential, stem cells phenotype).	3 years