Status:
RECRUITING
Determination of Microbiological Factors Associated With Poor Response to Neoadjuvant Treatment in Rectal Cancers
Lead Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Conditions:
Rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this project is to determine in a non-invasive manner (fecal samples) the predictive value of the intestinal microbiota and the presence of genotoxin-producing bacteria on the respons...
Detailed Description
Rectal cancer is the 8th leading cause of cancer in the world with more than 300,000 deaths in 2018. In addition to surgery, neoadjuvant treatment has proven its value in reducing local recurrences. E...
Eligibility Criteria
Inclusion
- Histologically proven lower and mid-rectal adenocarcinoma at clinical stage II and III
- Patient is to receive neoadjuvant treatment (radiochemotherapy or chemotherapy or radiotherapy). Induction chemotherapy such as folfox or folfirinox is allowed
- Patient who has signed the informed consent of the study
- Male or female ≥ 18 years old
- 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
- Antibiotic treatment at the time or in the month preceding stool sampling
- Presence of an ostomy
- Previous treatment for rectal cancer
- Patient not affiliated to a French social protection system
- Patient not in favour of good compliance with treatment for psychological, family, social or geographical reasons
- Legal incapacity (Patient under curatorship or guardianship)
- Prior radiation therapy or pelvic curia in the year prior to inclusion
- History of other cancers in the last 5 years (except for in-situ cervical carcinomas and non-melanoma skin carcinomas treated optimally)
- Pregnant or breastfeeding woman
Key Trial Info
Start Date :
January 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2030
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT04103567
Start Date
January 14 2020
End Date
January 30 2030
Last Update
February 12 2025
Active Locations (2)
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1
Institut régional du Cancer de Montpellier
Montpellier, Hérault, France, 34298
2
CHU Clermont-Ferrand
Clermont-Ferrand, Puy De Dôme, France, 63000