Metronidazole as Preoperative Therapy in CRC / FusoMetro-001

Ki vehet részt

• 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

Ki nem vehet részt

• 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