NCT05748145 Metronidazole as Preoperative Therapy in CRC / FusoMetro-001
| NCT ID | NCT05748145 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Oncology Institute of Southern Switzerland |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-09-11 |
| Primary Completion | 2026-12-31 |
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 40 participants in total. It began in 2023-09-11 with a primary completion date of 2026-12-31.
⚠ 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
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05748145 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Cancer. 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 NCT05748145 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 NCT05748145 currently recruiting?
Yes, NCT05748145 is actively recruiting participants. Contact the research team at sara.dedosso@eoc.ch for enrollment information.
Where is the NCT05748145 trial being conducted?
This trial is being conducted at Bellinzona, Switzerland.
Who is sponsoring the NCT05748145 clinical trial?
NCT05748145 is sponsored by Oncology Institute of Southern Switzerland. The trial plans to enroll 40 participants.
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