Identifying Microbiological Factors Affecting Neoadjuvant Treatment Response in Rectal Cancer

Determination of Microbiological Factors Associated With Poor Response to Neoadjuvant Therapy in Rectal Cancers: Focus on Cyclomodulin-producing Escherichia Coli

This study is testing whether the bacteria in the gut can help predict how well people with rectal cancer respond to their treatment before surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 220 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 2 sites (Montpellier, Hérault and 1 other locations)
• Trial ID: NCT04103567 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed lower and mid-rectal adenocarcinoma at clinical stages II and III who are set to receive neoadjuvant treatment.

Not a fit: Patients with prior treatment for rectal cancer or those currently on antibiotic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enable more personalized treatment strategies for rectal cancer, potentially improving patient outcomes.

How similar studies have performed: While some studies have explored the role of microbiota in cancer treatment responses, this specific approach focusing on rectal cancer and genotoxin-producing bacteria is relatively novel.

Eligibility criteria

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 this trial is running

Montpellier, Hérault and 1 other locations

• 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

Conditions: Rectal Cancer, rectal, cancer, cyclomodulin, microbiological factors