Tests metronidazole before surgery in people with colorectal cancer
Tests metronidazole, an antibiotic, given before surgery in adults with colorectal cancer.
Plain-language title generated from the registry record
Registry title: Metronidazole as Preoperative Therapy in CRC / FusoMetro-001
Key facts
- Where
- Bellinzona, SwitzerlandSee the site
- Phase
- Phase 2
Where in Switzerland
- Oncology Institute of Southern SwitzerlandBellinzona, SwitzerlandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Oncology Institute of Southern Switzerland
- Trial code
- NCT05748145
- Record updated
- 18 November 2025
- Original description
The proposed proof-of concept trial aims at determining the effectiveness of metronidazole in decreasing the Fusobacterium nucleatum load in tissues and possibly on its detrimental effects on tumor cells and tumor microenvironment.Read full original descriptionShow less
Preoperative Treatment With Metronidazole to Evaluate the Efficacy in Reducing Fusobacterium Nucleatum Tumor Colonization in Patients With Colorectal Cancer (CRC): a Proof-of-concept Trial
The proposed proof-of concept trial aims at determining the effectiveness of metronidazole in decreasing the Fusobacterium nucleatum load in tissues and possibly on its detrimental effects on tumor cells and tumor microenvironment.
Inclusion: 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: 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; Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),; Participation in another study with investigational drug within the 30 days preceding and during the present study,; Inability to consent and follow the procedures of the study e.g. due to language problems, psychological disorders, dementia, etc. of the participant,; 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; Insufficient material on the tissue biopsy to be left in the archives of the Cantonal Institute of Pathology for further evaluations/analyses; Women who are pregnant or breast feeding; Fertile women or men who do not use safe contraception during the study period.