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

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ClinicalTrials.gov Identifier: NCT02849158
Recruitment Status : Recruiting
First Posted : July 29, 2016
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
Institut Curie

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

Condition or disease Intervention/treatment Phase
Rectum Adenocarcinoma Other: Biopsy Not Applicable

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 .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Interest in Studying Fibroblast Before and After Neoadjuvant Chemo-radiotherapy in Patient With Locally Advanced Rectal Adenocarcinoma : Exploratory Study
Actual Study Start Date : June 9, 2017
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: Biopsy
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.
Other: Biopsy
Rectoscopy with biopsy




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02849158


Contacts
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Contact: Pierre FUMOLEAU, MD +33156245630 pierre.fumoleau@curie.fr
Contact: Isabelle TURBIEZ, CRA +33147111659 isabelle.turbiez@curie.fr

Locations
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France
Institut Curie Recruiting
Paris, Ile De France, France, 75248
Contact: Pascale MARIANI, MD       pascale.mariani@curie.fr   
Institut Curie - Hôpital René Huguenin Recruiting
Saint-Cloud, Ile De France, France, 92210
Contact: Amani ASNACIOS LECERF, MD       amani.asnacios@curie.fr   
INSTITUT CURIE - Site Paris Recruiting
Paris, France, 75005
Contact: Pascale MARIANI, MD    01..44.32.46.49    pascale.mariani@curie..fr   
Sponsors and Collaborators
Institut Curie
Investigators
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Principal Investigator: Pascale MARIANI, LDD Institut Curie

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Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT02849158     History of Changes
Other Study ID Numbers: IC 2015-12
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Curie:
Rectoscopy
Proctectomy
Fibroblasts
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms