RecruitingPhase 2NCT06793137

Intestinal Microbiome Modulation With Antibiotics in the Neoadjuvant Treatment of Locally Advanced Rectal Cancer

Phase II Trial for Intestinal Microbiome Modulation With Antibiotics in the Neoadjuvant Treatment of Locally Advanced Rectal Cancer


Sponsor

AC Camargo Cancer Center

Enrollment

100 participants

Start Date

Jul 22, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether giving antibiotics to alter the gut's bacterial environment before surgery and chemotherapy for rectal cancer can improve how well the treatment works. Gut bacteria (the microbiome) may influence the immune system's ability to fight cancer. **You may be eligible if...** - You are over 18 with confirmed rectal cancer (adenocarcinoma) of the middle or lower rectum - Your cancer is locally advanced or in a location that may require removal of the rectum - You are eligible to receive full chemotherapy and radiation before surgery **You may NOT be eligible if...** - Your cancer has a specific genetic marker (microsatellite instability) that may benefit from immunotherapy instead - You are not healthy enough for the full treatment program - You have a type of cancer other than adenocarcinoma Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMetronidazole

This intervention involves administering the oral antibiotic metronidazole during the first seven days of radiotherapy for patients with locally advanced rectal adenocarcinoma who are undergoing total neoadjuvant treatment. Metronidazole is considered a safe medication, with a very low risk of adverse effects. It is commonly used to treat infections caused by anaerobic bacteria that are part of the intestinal microbiota. Additionally, it is well established that certain genera of anaerobic bacteria are linked to a poorer response to treatment.


Locations(1)

A.C Camargo Cancer Center

São Paulo, São Paulo, Brazil

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NCT06793137


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