Identifying Microbiological Factors Affecting Neoadjuvant Treatment Response in Rectal Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project aims to non-invasively assess the predictive value of intestinal microbiota and genotoxin-producing bacteria in patients with rectal cancer undergoing neoadjuvant treatment. By analyzing fecal samples, the study seeks to understand how these microbiological factors influence treatment response, which is crucial for tailoring personalized therapies. The findings could enhance the decision-making process regarding treatment intensification or de-escalation based on individual patient responses. Ultimately, this research could lead to improved outcomes for patients with rectal cancer.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Histologically proven lower and mid-rectal adenocarcinoma at clinical stage II and III
2. Patient is to receive neoadjuvant treatment (radiochemotherapy or chemotherapy or radiotherapy). Induction chemotherapy such as folfox or folfirinox is allowed
3. Patient who has signed the informed consent of the study
4. Male or female ≥ 18 years old
5. Appropriate contraceptive measures should be used by both men and non-menopausal women before entering the trial until at least 8 weeks after the last course of radiochemotherapy. The investigator should inform the patient about the contraceptive measures to be used.

Exclusion Criteria:

1. Antibiotic treatment at the time or in the month preceding stool sampling
2. Presence of an ostomy
3. Previous treatment for rectal cancer
4. Patient not affiliated to a French social protection system
5. Patient not in favour of good compliance with treatment for psychological, family, social or geographical reasons
6. Legal incapacity (Patient under curatorship or guardianship)
7. Prior radiation therapy or pelvic curia in the year prior to inclusion
8. History of other cancers in the last 5 years (except for in-situ cervical carcinomas and non-melanoma skin carcinomas treated optimally)
9. Pregnant or breastfeeding woman

Where it's running

• Institut régional du Cancer de Montpellier
  Montpellier, Hérault, France Recruiting
• CHU Clermont-Ferrand
  Clermont-Ferrand, Puy De Dôme, France Not yet recruiting

Study contacts

• Study coordinator: Aurore MOUSSION, MD
• Email: Aurore.Moussion@icm.unicancer.fr
• Phone: 0467612446

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Single vs. double stapling and purse-string techniques after rectal cancer surgery

  This trial tests whether using a single-stapling method to join the bowel after rectal cancer surgery results in fewer leaks compared with the double-stapling method.

  Recruiting Alexandria University · Alexandria · NCT07929415

• DEM301 in advanced colorectal cancer: a first-in-human test

  This first-in-human Phase 1 study tests DEM301 in adults with advanced metastatic colorectal cancer to see if it is safe, how it behaves in the body, and whether it shows any signs of activity.

  Recruiting at 2 sites Phase 1 DEM BioPharma, Inc. · Birtinya, Queensland and 1 other locations · NCT07805369

• Rectal cancer registry to track real-world treatments and outcomes

  This registry collects real-world data on how locally advanced rectal cancer is treated in Austria, to see how TNT and dMMR/MSI-H cases are managed and what outcomes occur.

  Recruiting at 2 sites Austrian Breast & Colorectal Cancer Study Group · Wiener Neustadt, Lower Austria and 5 other locations · NCT07780305

• Aerobic exercise and guided imagery for bowel problems after rectal cancer surgery

  This study tests whether a program of aerobic exercise plus guided imagery helps people with low anterior resection syndrome after rectal cancer surgery.

  Recruiting Biruni University · Istanbul · NCT07732894

• Active surveillance vs chemoradiotherapy after local removal of intermediate-risk T1 rectal cancer

  This study tests whether close follow-up alone after local removal of early rectal cancer can match the cancer control of adding chemoradiotherapy, while reducing treatment-related side effects.

  Recruiting at 2 sites Medical University of Gdansk · Limoges and 2 other locations · NCT07669298

• Different-Dose Short-Course Radiotherapy With CAPOX, PD-1 Blockade, and IL-2 in Locally Advanced Rectal Cancer

  This phase II trial tests whether a low-dose short-course radiotherapy combined with CAPOX, a PD-1 blocker, and IL-2 works as well as the standard-dose short-course approach in patients with locally advanced rectal cancer.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07646639

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.