Octreotide treatment to improve nutritional recovery after surgery for patients with esophageal or gastric cancer, a prospective randomized open label phase II study - OTIS - OTIS

Karolinska Universitetssjukhuset0 个研究点目标入组 172 人开始时间: 2020年1月20日最近更新: 2024年2月26日

适应症

试验速览

暂无简介。

•Pathologic anatomic analysis (PAD) confirmed esophageal or gastric cancer
•Gastrectomy or esophagectomy with curative intent
•=18 years of age
•Signed informed consent
•Able to comply with the procedures of the study protocol, in the opinion of the investigator
•Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, if they are using effective methods of contraception during the study. Acceptable birth control methods are those with a failure rate of less than 1% per year when used consistently and correctly. A negative pregnancy test is required for participation.
•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 86
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 86

•Non-radical operation (defined by macroscopic assessment) or metastatic disease diagnosed at the time of surgery
•Complications leading to restrictions in postoperative oral intake
•Advanced comorbidity with ASA score III or more
•Bradycardia (defined as resting heart rate of under 60 beats per minute)
•Chronic obstructive pulmonary disease
•Chronic liver disease
•Insulinoma
•Kidney failure
•Concomitant medication with: cyclosporine, cimetidine, bromocriptine, quinidine, or terfenadine.
•Known or suspected allergy to octreotide
•Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
•Pregnant or nursing female
•Participation or recent participation in a clinical study with an investigational product (within the last 3 months). Previous participation in this study.

发起方