Trattamento preoperatorio con metronidazolo per valutare l'efficacia nel ridurre la colonizzazione tumorale da parte di Fusobacterium nucleatum in pazienti con tumore del colon-retto

Drug: Metronidazole Oral

Gender: All
Maximum age: N/A
Minimum age: 18 Years

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