NCT06793137 Intestinal Microbiome Modulation With Antibiotics in the Neoadjuvant Treatment of Locally Advanced Rectal Cancer
| NCT ID | NCT06793137 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | AC Camargo Cancer Center |
| Condition | Rectal Cancer, Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-07-22 |
| Primary Completion | 2025-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2024-07-22 with a primary completion date of 2025-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 .
Eligibility Criteria
Inclusion Criteria: * Patients over 18 years old with middle and lower rectal adenocarcinoma, classified as locally advanced or where the tumor´s location necessitates rectal amputation surgery; * Tumors located below the peritoneal reflection, as determined by MRI, will be defined as middle and lower rectum; * Patients eligible for rectal amputation will be those with tumor whose distal margin is less than 2,0cm from the pectineal line, as determined by rectoscopy, or less than 2,0cm from the anorectal ring by palpation or MRI. * Patients with middle rectum cancer candidates for radiotherapy as part of neoadjuvant treatment will be included according to the following criteria: mesorectal fascia compromised by direct extension of the primary tumor or by an affected lymph node; cT4 tumors. Exclusion Criteria: * Patients without performance status for total neoadjuvant treatment; * Histologies other than adenocarcinoma; * Adenocarcinomas with a microsatellite instability phenotype, as determined by immunohistochemistry; * Patients with middle rectal tumors who are not indicated for radiotherapy in the neoadjuvant treatment regimen, according to the institutional protocol (tumors cT3N0, with free mesorectal fascia; cT1-3 N+, with free mesorectal fascia).
Contact & Investigator
Samuel Aguiar Jr, MD, PhD
PRINCIPAL INVESTIGATOR
A.C. Camargo Cancer Center
Frequently Asked Questions
Who can join the NCT06793137 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rectal Cancer, Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06793137 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06793137 currently recruiting?
Yes, NCT06793137 is actively recruiting participants. Contact the research team at samuel.aguiar@accamargo.org.br for enrollment information.
Where is the NCT06793137 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT06793137 clinical trial?
NCT06793137 is sponsored by AC Camargo Cancer Center. The principal investigator is Samuel Aguiar Jr, MD, PhD at A.C. Camargo Cancer Center. The trial plans to enroll 100 participants.
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