Rectum AdenocarcinomaFibroRectNCT02849158
Fibroblast Before and After Neoadjuvant Chemo-radiotherapy in Patient With Locally Advanced Rectal Adenocarcinoma
A study testing Biopsy in people with Rectum Adenocarcinoma, run by Institut Curie at 3 sites in France.
Trial summary
Single center interventional study to explore activity of fibroblasts in the tumor and away in the healthy rectal tissue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectum Adenocarcinoma
- What is being tested?
- Biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 3 sitesFrance
- Study dates
- 9 Jun 2017to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
INSTITUT CURIE - Site Paris
Paris, 75005
Institut Curie
Paris, Île-de-France Region, 75248
Institut Curie - Hôpital René Huguenin
Saint-Cloud, Île-de-France Region, 92210
About this study
Official title: Interest in Studying Fibroblast Before and After Neoadjuvant Chemo-radiotherapy in Patient With Locally Advanced Rectal Adenocarcinoma : Exploratory Study
Single center interventional study to explore activity of fibroblasts in the tumor and away in the healthy rectal tissue.
Read the 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 .
- Conditions
- Rectum Adenocarcinoma
- Being tested
- Biopsy
- Keywords
- Rectoscopy, Proctectomy, Fibroblasts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyOther
Rectoscopy with biopsy
| Study group | Role | What they receive |
|---|---|---|
| Biopsy | Experimental | 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. Receives: Other: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 years
Secondary outcomes (1)
Study of fibroblast impact on colorectal tumor cells (in vitro)
In vitro analysis including tumor cells characteristics: proliferation, invasive potential, stem cells phenotype).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study start9 Jun 2017
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectum AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascale MARIANI, LDD, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02849158
- Sponsor's protocol ID
- IC 2015-12
- Acronym
- FibroRect
- Status last verified
- Nov 2023
- First submitted
- 13 Jul 2016
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators will share de-identified data sets with interested researchers, educators or clinicians. Materials generated under the project will be disseminated in accordance with Institut Curie policies.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest in Studying Fibroblast Before and After Neoadjuvant Chemo-radiotherapy in Patient With Locally Advanced Rectal Adenocarcinoma : Exploratory Study
- ClinicalTrials.gov ID
- NCT02849158
- Acronym / sponsor ID
- FibroRect / IC 2015-12
- Conditions
- Rectum Adenocarcinoma
- Keywords
- Rectoscopy, Proctectomy, Fibroblasts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 9 Jun 2017 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 29 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biopsy | Experimental | Other: BiopsyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiopsyRectoscopy with biopsy | Other | Biopsy |
Primary outcome
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)
1 secondary outcome
Study of fibroblast impact on colorectal tumor cells (in vitro)
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Individual participant dataSharing planned: Yes. Investigators will share de-identified data sets with interested researchers, educators or clinicians. Materials generated under the project will be disseminated in accordance with Institut Curie policies.
Related trials for Rectum Adenocarcinoma
Recruiting
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
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RecruitingObservational study
ABCSG R07 Rectal Cancer Registry
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RecruitingPhase 2
A Study to Evaluate the Efficacy of VVD-133214 in Combination With Pembrolizumab Compared With Pembrolizumab Alone in Participants With Advanced Cancer of the Colon or Rectum
Colorectal Adenocarcinoma
Active, not recruitingPhase 1
A Study of Safety and Efficacy of KFA115 Alone and in Combo With Pembrolizumab in Patients With Select Advanced Cancers
Carcinoma, Non-Small-Cell Lung, Cutaneous Melanoma
Not yet recruitingPhase 2
A Study of Trastuzumab Deruxtecan (T-DXd) and Cetuximab in People With Colorectal Cancer
Colorectal Cancer, Adenocarcinoma of the Colon
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascale MARIANI, LDD principal investigator
Institut Curie
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy in people with Rectum Adenocarcinoma, run by Institut Curie at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proteomic level evaluation in intra-tumor fibroblast (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.