Double-blind, randomised, placebo-controlled, phase IIa trial on the efficacy and tolerability of an 8-week treatment with two different doses of budesonide orodispersible tablets vs. placebo for prevention of oesophageal strictures in adult patients after endoscopic submucosal dissection for squamous cell carcinoma - Budesonide orodispersible tablets vs. placebo to prevent oesophageal strictures after ESD for SCC

Dr. Falk Pharma GmbH0 个研究点目标入组 90 人开始时间: 2019年9月2日最近更新: 2023年8月21日

适应症

试验速览

暂无简介。

•Signed informed consent,
•Male or female patients, 18 to 80 years of age,
•Estimated life expectancy of at least three years,
•ECOG Performance Status of = 2 at the randomisation visit (i.e. after the ESD-procedure),
•Biopsy proven or endoscopically suspect oesophageal SCC and/or high grade dysplasia in a focal lesion of the squamous epithelium, treated with ESD,
•Mucosal defect = 75% oesophageal circumference after ESD, or patient with a complete circumferential ESD,
•Negative pregnancy test in females of childbearing potential at the screening visit.
•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 60
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•Any prior or intended chemotherapy for oesophageal cancer,
•Any prior ESD in the area where ESD will be done,
•Any prior or intended oesophageal surgery or surgery for the mediastinum, endoscopic mucosal resection (EMR), or radio frequency ablation (RFA), in the area where ESD will be done,
•Evidence of regional lymph node metastases or distant metastases prior to ESD,
•Any prior or intended radiotherapy which involves or affects the area of ESD,
•Any prior endoscopic dilation for oesophageal stenosis,
•Any other concomitant oesophageal disease,
•Any severe concomitant disease, which in the opinion of the investigator might have an influence on the patient’s compliance or the interpretation of the results, or any disorder which in the opinion of the investigator might affect the patient’s safety,
•Any systemic therapy for any reason that may affect assessment of primary or secondary endpoints.

发起方