NCT05748145Recrutement en cours
Metronidazole as Preoperative Therapy in CRC / FusoMetro-001
Résumé
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.
Critères d'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.
Critères d'exclusion
• 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
Contacts
Les coordonnées de l'équipe de l'essai s'affichent sur demande.
Voir la fiche officielle de l'essai- Statut
- Recrutement en cours
- Phase
- Phase 2
- Type d'étude
- Interventionnelle
- Pays
- Suisse
- Promoteur
- Oncology Institute of Southern Switzerland(Autre)
- N° de protocole
- FusoMetro-001
- Pathologies
- Colorectal Cancer
- Interventions
- Médicament
Traitements évalués
- Metronidazole Oral
Lieux · 1
- Bellinzona, SuisseOncology Institute of Southern SwitzerlandRecrute dans ce centre
Au total, dans le monde, le seul centre listé au registre recrute.
Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 18 novembre 2025).
Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.
Voir aussi
Autres versions
Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.