Actively Recruiting
Intestinal Microbiome Modulation With Antibiotics in the Neoadjuvant Treatment of Locally Advanced Rectal Cancer
Led by AC Camargo Cancer Center · Updated on 2025-01-29
100
Participants Needed
1
Research Sites
92 weeks
Total Duration
On this page
Sponsors
A
AC Camargo Cancer Center
Lead Sponsor
C
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Collaborating Sponsor
AI-Summary
What this Trial Is About
Colorectal cancer is the second most common malignancy worldwide and one-third of these tumors are located in the rectum. The treatment may involve up to three modalities: radiotherapy, chemotherapy, and surgery. For several years, thanks mainly to Brazilian researchers, subgroups of patients have been selected for non-surgical treatment when chemoradiotherapy induces a complete clinical response. These treatment regimens have reached a plateau leading researchers to seek strategies that can increase response rates. Intestinal microbiota studies have shown that an overpopulation of certain anaerobic bacteria is generally associated with poorer treatment response. No study has attempted to intervene in the gut microbiota to increase the complete response rate in rectal cancer. The proposal of the investigators aims to modulate the intestinal microbiota through a phase 2 clinical trial, with the use of metronidazole as the intervention .
CONDITIONS
Official Title
Intestinal Microbiome Modulation With Antibiotics in the Neoadjuvant Treatment of Locally Advanced Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years old with middle and lower rectal adenocarcinoma classified as locally advanced or requiring rectal amputation surgery
- Tumors located below the peritoneal reflection as determined by MRI
- Patients eligible for rectal amputation have tumors with distal margin less than 2.0 cm from the pectineal line by rectoscopy or less than 2.0 cm from the anorectal ring by palpation or MRI
- Patients with middle rectum cancer who are candidates for radiotherapy as part of neoadjuvant treatment with mesorectal fascia compromised by tumor or affected lymph node or cT4 tumors
You will not qualify if you...
- Patients unable to undergo total neoadjuvant treatment
- Patients with histologies other than adenocarcinoma
- Patients with adenocarcinomas showing microsatellite instability phenotype by immunohistochemistry
- Patients with middle rectal tumors not indicated for radiotherapy in neoadjuvant treatment according to institutional protocol (cT3N0 with free mesorectal fascia; cT1-3 N+ with free mesorectal fascia)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
A.C Camargo Cancer Center
São Paulo, São Paulo, Brazil, 01509-010
Actively Recruiting
Research Team
S
Samuel Aguiar Jr, MD, PhD
CONTACT
V
Virgilio S Silva, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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