Recruiting PHASE2 Rectal Cancer, Adenocarcinoma

New treatment option for Rectal Cancer, Adenocarcinoma

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

ClinicalTrials.gov ID: NCT06793137

What this study is testing

What is Metronidazole?

Metronidazole is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for rectal cancer, adenocarcinoma.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Patients over 18 years old with middle and lower rectal adenocarcinoma, classified as locally advanced or where the tumor´s location necessitates...
  • 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...
  • Patients with middle rectum cancer candidates for radiotherapy as part of neoadjuvant treatment will be included according to the following criteria...

You likely can't join if

  • 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...

The study team makes the final eligibility decision.

Where it's taking place

  • São Paulo, São Paulo, Brazil

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include São Paulo, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.