Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries.
Freddie Bray, Jacques Ferlay, Isabelle Soerjomataram...
https://pubmed.ncbi.nlm.nih.gov/30207593Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID04103567
Determination of Microbiological Factors Associated With Poor Response to Neoadjuvant Therapy in Rectal Cancers: Focus on Cyclomodulin-producing Escherichia Coli
Led by Institut du Cancer de Montpellier - Val d'Aurelle · Updated on 2025-02-12
220
Participants Needed
2
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring how the intestinal microbiota and certain bacteria that produce genotoxins, like cyclomodulin-producing Escherichia coli, might predict how patients with rectal cancer respond to neoadjuvant treatment. This study focuses on rectal cancer, a common and deadly cancer worldwide, aiming to improve personalized treatment by identifying factors that influence treatment response. The study is interventional and involves collecting biological samples to better understand these predictive factors. Participants provide fecal samples at several points: during a consultation before treatment, after completing neoadjuvant treatment, and before surgery. Alongside these collections, clinical data is recorded in a database to analyze the relationship between bacterial colonization and treatment outcomes. The neoadjuvant treatments include radiochemotherapy, chemotherapy, or radiotherapy, and induction chemotherapy is permitted. Participants will be monitored for about one year to assess changes in bacterial colonization and how this relates to their response to treatment. Researchers will evaluate the proportion of patients with poor response to neoadjuvant therapy depending on their bacterial colonization status. They will also study survival outcomes and shifts in the intestinal bacterial composition. The study involves non-invasive sample collection and clinical data review, with no experimental drug administration, focusing on predictive markers for treatment planning.
CONDITIONS
Brief Title
Determination of Microbiological Factors Associated With Poor Response to Neoadjuvant Treatment in Rectal Cancers
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Histologically proven lower and mid-rectal adenocarcinoma at clinical stage II and III
- Planned neoadjuvant treatment including radiochemotherapy, chemotherapy, or radiotherapy (induction chemotherapy like folfox or folfirinox allowed)
- Signed informed consent for the study
- Male or female aged 18 years or older
- Use of appropriate contraceptive measures by men and non-menopausal women from before the trial until at least 8 weeks after the last radiochemotherapy course
You will not qualify if you...
- Antibiotic treatment at the time or within one month before stool sampling
- Presence of an ostomy
- Previous treatment for rectal cancer
- Not affiliated with a French social protection system
- Poor compliance with treatment due to psychological, family, social, or geographical reasons
- Legal incapacity such as curatorship or guardianship
- Prior radiation therapy or pelvic curia within one year before inclusion
- History of other cancers in the last 5 years except in-situ cervical carcinoma and optimally treated non-melanoma skin carcinoma
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) during inclusion consultation with surgeon
Neoadjuvant Treatment
Duration - Varies depending on treatment regimen
Participants undergo neoadjuvant treatment which may include radiochemotherapy, chemotherapy, or radiotherapy prior to surgery.
Visits according to treatment schedule (not detailed in this trial)
Biological Sample Collection
Duration - Occurs during the treatment period up to surgery
Participants provide fecal samples at multiple points: during inclusion consultation, after neoadjuvant treatment, and before surgery to assess microbiological factors.
3 sample collections aligned with clinical visits
Trial Site Locations
Total: 2 locations
1
Institut régional du Cancer de Montpellier
Montpellier, Hérault, France, 34298
Actively Recruiting
2
CHU Clermont-Ferrand
Clermont-Ferrand, Puy De Dôme, France, 63000
Not Yet Recruiting
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Research Team
A
Aurore MOUSSION, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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Published Research Related To This Trial
Rectal cancer: French Intergroup clinical practice guidelines for diagnosis, treatments and follow-up (SNFGE, FFCD, GERCOR, UNICANCER, SFCD, SFED, SFRO).
Jean-Pierre Gérard, Thierry André, Frédéric Bibeau...
https://pubmed.ncbi.nlm.nih.gov/28179091Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer: 12-year follow-up of the multicentre, randomised controlled TME trial.
Willem van Gijn, Corrie A M Marijnen, Iris D Nagtegaal...
https://pubmed.ncbi.nlm.nih.gov/21596621Preoperative versus postoperative chemoradiotherapy for rectal cancer.
Rolf Sauer, Heinz Becker, Werner Hohenberger...
https://pubmed.ncbi.nlm.nih.gov/15496622Pathological features of rectal cancer after preoperative radiochemotherapy.
O Dworak, L Keilholz, A Hoffmann
https://pubmed.ncbi.nlm.nih.gov/9112145Operative versus nonoperative treatment for stage 0 distal rectal cancer following chemoradiation therapy: long-term results.
Angelita Habr-Gama, Rodrigo Oliva Perez, Wladimir Nadalin...
https://pubmed.ncbi.nlm.nih.gov/15383798Watch-and-wait approach versus surgical resection after chemoradiotherapy for patients with rectal cancer (the OnCoRe project): a propensity-score matched cohort analysis.
Andrew G Renehan, Lee Malcomson, Richard Emsley...
https://pubmed.ncbi.nlm.nih.gov/26705854Organ preservation for rectal cancer (GRECCAR 2): a prospective, randomised, open-label, multicentre, phase 3 trial.
Eric Rullier, Philippe Rouanet, Jean-Jacques Tuech...
https://pubmed.ncbi.nlm.nih.gov/28601342Tailored Treatment Strategy for Locally Advanced Rectal Carcinoma Based on the Tumor Response to Induction Chemotherapy: Preliminary Results of the French Phase II Multicenter GRECCAR4 Trial.
Philippe Rouanet, Eric Rullier, Bernard Lelong...
https://pubmed.ncbi.nlm.nih.gov/28594714Microbial ecology of the gastrointestinal tract.
D C Savage
https://pubmed.ncbi.nlm.nih.gov/334036