Preoperative endoscopic treatment with fosfomycin and metronidazole in patients with right-sided colon cancer and colon adenoma: a clinical proof-of-concept intervention studyMEFO trial
- Conditions
- Colon cancer in track 1.Colon adenoma in track 2.MedDRA version: 20.0Level: PTClassification code 10009944Term: Colon cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10048832Term: Colon adenomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-000131-51-DK
- Lead Sponsor
- Zealand University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 28
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 (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 (track 2a)
Written informed consent must be obtained.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 28
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 28
•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 (ASA score) 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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method