Status:
COMPLETED
Preoperative Endoscopic Treatment With Fosfomycin and Metronidazole in Patients With Right-sided Colon Cancer and Colon Adenoma (MEFO-trial)
Lead Sponsor:
Zealand University Hospital
Collaborating Sponsors:
Costerton Biofilm Center
Reponex Pharmaceuticals A/S
Conditions:
Right-sided Colon Cancer
Right-sided Colon Adenoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Clinical studies have shown that patients with right-sided colon cancer have reduced progression-free and overall survival compared to patients with left-sided colon cancer. At the same time, patients...
Detailed Description
Background Dysbiosis and known bacterial drivers play a significant role in the carcinogenesis of colorectal cancer. Among bacterial drivers, Fusobacterium nucleatum (FN) and the formation of biofilm ...
Eligibility Criteria
Inclusion
- Inclusion criteria for track 1 and 2a:
- Male and female patients above 18 years of age with either:
- right-sided colon cancer tumor with adenocarcinoma histologically verified scheduled for open or laparoscopic resection at the Department of Surgery, Herlev Hospital or Zealand University Hospital for track 1.
- Right-sided adenomas ≥2cm in diameter endoscopically verified scheduled for endoscopic mucosal resection at the Department of Surgery, Herlev Hospital or Zealand University Hospital for track 2a.
- ASA I,II or III
- The caecum must be reached by the endoscope.
- Inclusion criteria for retrospective controls (track 2b):
- Male and female patients above 18 years of age who were operated for colon adenoma ≥2cm in diameter in the right hemicolon in 2018 at Department of Surgery, Zealand University Hospital. They will be matched 2:1 with the patients included in track 2a (cases) based on age and gender and pathology of the tumor.
Exclusion
- Exclusion criteria for track 1 and track 2a
- Patients with previous allergic reaction to fosfomycin and/or metronidazole
- Patients under current antibiotic treatment or patient who had the last dose of antibiotics 30 days prior to inclusion.
- Patients with a non-passable tumor or patients where a part of the tumor is not visible during endoscopy (Track 1)
- Patients with neoadjuvant chemotherapy or radiation 12 months prior to the resection.
- Patients with a history of familial adenomatous polyposis (FAP) or hereditary nonpolyposis colorectal cancer (HNPCC)
- Patients with a history of inflammatory bowel disease (IBD)
- Patients under current treatment with warfarin (Marevan) and phenprocoumon (Marcoumar), or NOAK such as dabigatran (Pradaxa®), rivaroxiban (Xarelto®), edoxaban (Lixiana®) or apixaban (Eliquis®)
- Patients under current treatment with Fenemal (Phenobarbital)
- Patients who previously have received a fecal transplantation
- Patients who have previously had colorectal cancer, and are now presenting with a secondary colon tumor.
- Patients with a current alcohol use disorder (AUD): defined as a patient who are currently drinking 8 or more drinks/week for women and 15 or more drinks/week for men.
- Predictable poor compliance (psychiatric disease, not speaking fluent Danish, mentally, impaired etc)
- Patients with an American Society of Anaesthesiologists physical status
- Classification (ASAscore) of IV.
- Patients unable to be sedated
- Pregnancy or lactation (fertile women must have a negative serum or urine pregnancy test to participate)
- Fertile women who do not use safe contraception during the study period
- Following contraceptive methods are acceptable when used consistently and in accordance, with both the product label and the instructions of the physician are:
- Oral contraceptive, either combined or progestogen alone
- Injectable progestogen
- Implants of levonorgestrel
- Estrogenic vaginal ring
- Percutaneous contraceptive patches
- Intrauterine device or intrauterine system with a documented failure rate \< 1% per year
- Male partner sterilization (vasectomy with documented azoospermia) prior to female patient ́s entry into the study, and this male is the sole partner for that patient.
- Double barrier method: condom with spermicidal agent (foam/gel/film/cream/suppository), condom and occlusive cap (diaphragm or cervical/vault cap) with vaginal spermicidal agent (foam/gel/film/cream/suppository).
- Exclusion criteria for retrospective controls (track 2b):
- Patients under the age of 18 years during the resection for colon adenoma
- Patients who were under antibiotic treatment during the EMR or patients who had the last dose of antibiotics 30 days prior to EMR
- Patients with neoadjuvant chemotherapy or radiation 12 months prior to the resection
- Patients with a history of familial adenomatous polyposis (FAP) or hereditary nonpolyposis colorectal cancer (HNPCC)
- Patients with a history of inflammatory bowel disease (IBD)
- Patients who previously have received a fecal transplantation
- Patients who have previously had colorectal cancer
- Patients registered in "Vævsanvendelsesregistret"
- Patients with insufficient tissue samples
Key Trial Info
Start Date :
January 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2023
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04312360
Start Date
January 16 2020
End Date
July 1 2023
Last Update
September 7 2023
Active Locations (2)
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1
Department of Surgery, Herlev Hospital
Copenhagen, Denmark, 2730
2
Department of Surgery, Zealand University Hospital
Køge, Denmark, 4200