Clinical trial NCT02849158: Fibroblast Before and After Neoadjuvant Chemo-radiotherapy in Patient With Locally Advanced Rectal Adenocarcinoma
Official title: Interest in Studying Fibroblast Before and After Neoadjuvant Chemo-radiotherapy in Patient With Locally Advanced Rectal Adenocarcinoma : Exploratory Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectum Adenocarcinoma
Keywords: Rectoscopy
Proctectomy
Fibroblasts
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2016-07-29
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 .

Eligibility criteria: 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

Primary outcomes:
measure: Proteomic level evaluation in intra-tumor fibroblast
timeFrame: 3 years
Secondary outcomes:
measure: Study of fibroblast impact on colorectal tumor cells (in vitro)
timeFrame: 3 years
Other outcomes:
measure: Metastatic spread evaluation
timeFrame: 3 years
measure: Outcomes 1 to 3 correlation with histological response after RT-CT
timeFrame: 3 years
measure: Disease-free survival
timeFrame: 5 years
Locations:
city: Paris
country: France
facility: Institut Curie
state: Ile De France
city: Saint-Cloud
country: France
facility: Institut Curie - Hôpital René Huguenin
state: Ile De France
city: Paris
country: France
facility: INSTITUT CURIE - Site Paris
Study officials:
affiliation: Institut Curie
name: Pascale MARIANI, LDD
role: PRINCIPAL_INVESTIGATOR
References: