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

Prior treatment

• Participation or recent participation in a clinical study with an investigational product (within the last 3 months). Previous participation in this study.
• Concomitant medication with: cyclosporine, cimetidine, bromocriptine, quinidine, or terfenadine

Other illness

• Non-radical operation (defined by macroscopic assessment) or metastatic disease diagnosed at the time of surgery
• Known or suspected allergy to octreotide
• Bradycardia (defined as resting heart rate of under 60 beats per minute)
• Chronic obstructive pulmonary disease
• Chronic liver disease
• Kidney failure

Other

• Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
• Pregnant or nursing female
• Complications leading to restrictions in postoperative oral intake
• Advanced comorbidity with ASA score III or more
• Insulinoma

• 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, only after A. leaving a negative result on a highly sensitive pregnancy test, B. are using a highly effective method of contraception during treatment, and C. throughout the study. Acceptable birth control methods are those with a failure rate of less than 1% per year when used consistently and correctly (a list of approved methods is provided in appendix D). An additional pregnancy test is to be provided at end of exposure.