Cancer of RectumNeo-Flo-RectNCT06181201
Association Between the Composition of the Intestinal Microbiota and Tumor Response in Locally Advanced Rectal Cancer
An observational study of Cancer of Rectum, run by Centre Oscar Lambret at 1 site in France.
Trial summary
This is an observational, single-centre study (RIPH3) for patients with rectal cancer soon to be treated with chemotherapy (+/- neo-adjuvant radio-chemotherapy) looking at the relationship between the composition of the gut microbiota before treatment and the tumour response after chemotherapy +/- radio-chemotherapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Rectum
- What is being tested?
- Stool collection
- Type of treatment
- Surgery or procedure
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- 19 Feb 2024to 8 Oct 2024
- Phase
- Observational
- 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
Study population: People with locally advanced rectal cancer who are to receive induction chemotherapy with FLOFIRINOX followed or not by neo-adjuvant radio-chemotherapy of the Cap50 type
Who may be able to join
- Histologically proven stage II and III adenocarcinoma of the lower and middle rectum
- Patient undergoing preoperative treatment with induction chemotherapy (Folfirinox) followed or not by radio-chemotherapy of the Cap50 type
- Male or female patient aged 18 years or older
- Normal weight, overweight or moderately obese (BMI between 18.5 and 34.9)
- Patient residing in the Lille metropolitan area
- Patient affiliated to a French social protection scheme
- Patient having given his non-opposition
Who cannot join
- History of other concurrent cancers
- Presence of an intestinal (internal or external) or external urinary diversion
- Uncooperative patient for geographical, family, social or psychological reasons
- Limited legal capacity or legal incapacity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between the Composition of the Intestinal Microbiota Before Treatment and the Tumor Response After Induction Chemotherapy Followed or Not by Neo-adjuvant Radio-chemotherapy in Locally Advanced Rectal Cancer
This is an observational, single-centre study (RIPH3) for patients with rectal cancer soon to be treated with chemotherapy (+/- neo-adjuvant radio-chemotherapy) looking at the relationship between the composition of the gut microbiota before treatment and the tumour response after chemotherapy +/- radio-chemotherapy
Read the detailed description
Main objective: The main objective is to test the association between :
- the gut microbiota assessed from a stool sample before the start of neoadjuvant treatment of patients (T0) on the one hand, and
- complete histological response assessed on the surgical resection specimen in patients with histologically proven stage II and III rectal tumours treated with neo-adjuvant chemotherapy followed or not by Cap50 radiochemotherapy before surgery.
Primary endpoint: The primary endpoint will be complete histological response assessed on the surgical specimen after the neoadjuvant therapy regimen. This assessment will be performed according to the usual standards and blinded to any information on the gut microbiota and on the content of short-chain fatty acids and tryptophan derivatives.
Secondary objectives:
- To explore the profile of gut microbiota composition and short-chain fatty acid content in the two groups of patients (complete histological response or not), assessed before any treatment (T0).
- To assess the changes in the composition of the intestinal flora and the content of short chain fatty acids following treatment with induction chemotherapy (T1), then preoperative radiochemotherapy (T2) if applicable, by comparison of the preoperative sample with the initial sample (T0).
- Assess the association between these taxonomic and metabolic changes (T1-T0, T2-T0) on the one hand and the histological response on the other.
- To evaluate the association between the profile of the composition of the intestinal microbiota and the content of short-chain fatty acids, as well as calprotectin (a reliable and sensitive non-invasive marker of intestinal inflammation) assessed before any treatment (T0) on the one hand, and the occurrence of toxicity during treatment, in particular digestive toxicity.
Secondary endpoints:
- Percentage of different bacteria or families of bacteria (abundance) such as Ruminococcaceae in the intestinal flora and dosage of short-chain fatty acids;
- Rarefaction curves;
- Taxonomic indicators;
- Alpha and beta diversity indices of microbiota composition;
- Determination of calprotectin by ELISA on stool sample.
- Toxicity assessed by collecting adverse events during treatment with FOLFIRINOX and for some patients during radiochemotherapy, graded according to the NCI CTCAE v5 scale and classified according to the MEDDRA dictionary;
- Conditions
- Cancer of Rectum
- Being tested
- Stool collection
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool collectionProcedure or surgery
Stool collection is done with the "Coll-off" device (Zymo research, reference R1101-2-5) provided to the patient before and after the induction treatment and after the reference chemo-radiotherapy treatment (Cap50, Capecitabine). Collection must be carried out by the patient at home (collection using the "Coll-off" device and then transfer to a coproculture jar provided). The fresh sample is then picked up the same day by an approved transporter mandated by the promoter and will be stored at -20°C until the start of the analyses
| Study group | Role | What they receive |
|---|---|---|
| Person with rectal cancer | People with locally advanced rectal cancer who are to receive induction chemotherapy with FLOFIRINOX followed or not by neo-adjuvant radio-chemotherapy of the Cap50 type. Receives: Procedure: Stool collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiota description at T0
gut microbiota assessed from a stool sample before the start of neoadjuvant treatment of patients (T0) Measurement of gut microbiota composition at T0 by high-throughput sequencing of the 16S subunit of bacterial ribosomes
Measured: at baseline
histological response according to Ryan classification
complete histological response assessed on the surgical resection specimen in patients with histologically proven stage II and III rectal tumours treated with neo-adjuvant chemotherapy followed or not by Cap50 radiochemotherapy before surgery and according to Ryan classification.
TRG (TRG0-TRG3) TRG 3: extensive residual cancer with no evident tumor regression (poor or not response
Measured: after surgery, an average of 8 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start19 Feb 2024
- Primary completion8 Oct 2024
- Study completion8 Oct 2024
Why it stopped: Lack of eligible patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of RectumStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, L'Institut des sciences moléculaires (iSm2 UMR CNRS 7313)
- Responsible party
- Sponsor
- Investigators
- Mathias CHAMAILLARD, Study director, Institut National de la Santé Et de la Recherche Médicale, FranceMehrdad JAFARI, Principal investigator, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181201
- Sponsor's protocol ID
- NéoFloRect-2202
- Other IDs
- N° Id RCB: 2022-A00572-41
- Acronym
- Neo-Flo-Rect
- Status last verified
- Mar 2026
- First submitted
- 6 Dec 2022
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between the Composition of the Intestinal Microbiota Before Treatment and the Tumor Response After Induction Chemotherapy Followed or Not by Neo-adjuvant Radio-chemotherapy in Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT06181201
- Acronym / sponsor ID
- Neo-Flo-Rect / NéoFloRect-2202
- Conditions
- Cancer of Rectum
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of eligible patients
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, L'Institut des sciences moléculaires (iSm2 UMR CNRS 7313)
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 8 Oct 2024 (actual)
- Study completion
- 8 Oct 2024 (actual)
- First posted
- 26 Dec 2023 (actual)
- 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.
This is an observational, single-centre study (RIPH3) for patients with rectal cancer soon to be treated with chemotherapy (+/- neo-adjuvant radio-chemotherapy) looking at the relationship between the composition of the gut microbiota before treatment and the tumour response after chemotherapy +/- radio-chemotherapy
Detailed description
Main objective: The main objective is to test the association between :
- the gut microbiota assessed from a stool sample before the start of neoadjuvant treatment of patients (T0) on the one hand, and
- complete histological response assessed on the surgical resection specimen in patients with histologically proven stage II and III rectal tumours treated with neo-adjuvant chemotherapy followed or not by Cap50 radiochemotherapy before surgery.
Primary endpoint: The primary endpoint will be complete histological response assessed on the surgical specimen after the neoadjuvant therapy regimen. This assessment will be performed according to the usual standards and blinded to any information on the gut microbiota and on the content of short-chain fatty acids and tryptophan derivatives.
Secondary objectives:
- To explore the profile of gut microbiota composition and short-chain fatty acid content in the two groups of patients (complete histological response or not), assessed before any treatment (T0).
- To assess the changes in the composition of the intestinal flora and the content of short chain fatty acids following treatment with induction chemotherapy (T1), then preoperative radiochemotherapy (T2) if applicable, by comparison of the preoperative sample with the initial sample (T0).
- Assess the association between these taxonomic and metabolic changes (T1-T0, T2-T0) on the one hand and the histological response on the other.
- To evaluate the association between the profile of the composition of the intestinal microbiota and the content of short-chain fatty acids, as well as calprotectin (a reliable and sensitive non-invasive marker of intestinal inflammation) assessed before any treatment (T0) on the one hand, and the occurrence of toxicity during treatment, in particular digestive toxicity.
Secondary endpoints:
- Percentage of different bacteria or families of bacteria (abundance) such as Ruminococcaceae in the intestinal flora and dosage of short-chain fatty acids;
- Rarefaction curves;
- Taxonomic indicators;
- Alpha and beta diversity indices of microbiota composition;
- Determination of calprotectin by ELISA on stool sample.
- Toxicity assessed by collecting adverse events during treatment with FOLFIRINOX and for some patients during radiochemotherapy, graded according to the NCI CTCAE v5 scale and classified according to the MEDDRA dictionary;
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Person with rectal cancer | – | Procedure: Stool collectionPeople with locally advanced rectal cancer who are to receive induction chemotherapy with FLOFIRINOX followed or not by neo-adjuvant radio-chemotherapy of the Cap50 type. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with locally advanced rectal cancer who are to receive induction chemotherapy with FLOFIRINOX followed or not by neo-adjuvant radio-chemotherapy of the Cap50 type
Key inclusion criteria (7 listed)
- Histologically proven stage II and III adenocarcinoma of the lower and middle rectum
- Patient undergoing preoperative treatment with induction chemotherapy (Folfirinox) followed or not by radio-chemotherapy of the Cap50 type
- Male or female patient aged 18 years or older
- Normal weight, overweight or moderately obese (BMI between 18.5 and 34.9)
- Patient residing in the Lille metropolitan area
Key exclusion criteria (4 listed)
- History of other concurrent cancers
- Presence of an intestinal (internal or external) or external urinary diversion
- Uncooperative patient for geographical, family, social or psychological reasons
- Limited legal capacity or legal incapacity
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 |
|---|---|---|
| Stool collectionStool collection is done with the "Coll-off" device (Zymo research, reference R1101-2-5) provided to the patient before and after the induction treatment and after the reference chemo-radiotherapy treatment (Cap50, Capecitabine). Collection must be carried out by the patient at home (collection using the "Coll-off" device and then transfer to a coproculture jar provided). The fresh sample is then picked up the same day by an approved transporter mandated by the promoter and will be stored at -20°C until the start of the analyses | Procedure or surgery | Person with rectal cancer |
Primary outcome
Gut microbiota description at T0
Time frame: at baseline
gut microbiota assessed from a stool sample before the start of neoadjuvant treatment of patients (T0) Measurement of gut microbiota composition at T0 by high-throughput sequencing of the 16S subunit of bacterial ribosomes
histological response according to Ryan classification
Time frame: after surgery, an average of 8 months after inclusion
complete histological response assessed on the surgical resection specimen in patients with histologically proven stage II and III rectal tumours treated with neo-adjuvant chemotherapy followed or not by Cap50 radiochemotherapy before surgery and according to Ryan classification. TRG (TRG0-TRG3) TRG 3: extensive residual cancer with no evident tumor regression (poor or not response
Results and safety
The study was stopped early (reason given: Lack of eligible patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Mathias CHAMAILLARD study director
Institut National de la Santé Et de la Recherche Médicale, France
Mehrdad JAFARI principal investigator
Centre Oscar Lambret
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer of Rectum, run by Centre Oscar Lambret at 1 site 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 4 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: stopped early, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Lack of eligible patients). Results are not available in the source record.
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?
Gut microbiota description at T0 (time frame: at baseline). The study lists 2 primary outcomes in all. 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 18 Mar 2026.