Using metronidazole before surgery for colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of metronidazole in reducing the presence of Fusobacterium nucleatum in colorectal cancer tissues. The study focuses on patients with untreated, primary colorectal adenocarcinoma who are candidates for surgical resection. By administering metronidazole prior to surgery, the trial seeks to determine its impact on tumor growth and the tumor microenvironment. The research is based on previous findings that suggest Fusobacterium nucleatum may contribute to chemotherapy resistance and poor patient outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Written informed consent according to ICH/GCP regulations before registration.
* Age ≥ 18 years old
* Untreated, primary colorectal adenocarcinoma (\> 15 cm from the anal verge)
* Colonoscopy with endoscopic biopsy for disease confirmation and correlative studies.
* Candidates for surgical resection prior to administration of any therapy.

Exclusion Criteria:

* Insufficient material on the tissue biopsy to be left in the archives of the Cantonal Institute of Pathology for further evaluations/analyses
* Known prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives
* Oral or parenteral antibiotic therapy within the six weeks prior to enrolment
* Emergency surgery (planned within less than 14 days), where no opportunity to administer preoperative oral antibiotics exists
* Other malignant disease within 5 years prior to study enrollment, except basocellular or squamous skin cancer and carcinoma in situ cervices uteri
* Any previous anticancer treatment prior resection
* Women who are pregnant or breast feeding
* Fertile women or men who do not use safe contraception during the study period
* Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),
* Inability to consent and follow the procedures of the study e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
* Participation in another study with investigational drug within the 30 days preceding and during the present study,
* Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment, affect patient compliance or place the patient at high risk from treatment-related complications

Where it's running

• Oncology Institute of Southern Switzerland
  Bellinzona, Canton Ticino, Switzerland Recruiting

Study contacts

• Study coordinator: Sara De Dosso, MD
• Email: sara.dedosso@eoc.ch
• Phone: +41 91 811 93 02

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.