Metronidazole as Preoperative Therapy in CRC / FusoMetro-001
ConditionColorectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOncology Institute of Southern Switzerland
About this 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Metronidazole Oral
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov