EUCTR2019-000131-51-DK进行中（未招募）1 期
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 - MEFO trial
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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)
研究者
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