E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Undesired weight loss after operation for esophageal or gastric cancer |
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E.1.1.1 | Medical condition in easily understood language |
Undesired weight loss after operation for esophageal or gastric cancer |
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E.1.1.2 | Therapeutic area | Body processes [G] - Metabolic Phenomena [G03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10027415 |
E.1.2 | Term | Metabolic abnormality management |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine if intramuscular administered Octreotide can decrease weight loss after gastrectomy or esophagectomy due to cancer. |
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E.2.2 | Secondary objectives of the trial |
•To study if octreotide treatment affects the levels of gastrointestinal satiety hormones
•To determine if octreotide treatment affects body composition
•To determine if octreotide treatment affects postoperative health related quality of life
•To study if postoperative eating problems can be reduced by intramuscular administration of octreotide
•To study safety and tolerability of treatment with intramuscularly administered octreotide after gastrectomy or esophagectomy due to cancer
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Same title as main study.
Substudy 1 is a non randomized pilot study, examining 20 patients of which 10 after gastrectomy and 10 after esophagectomy, all receive octreotide treatment (3 monthly doses of 10 mg).
The primary objective is to study safety and tolerability of treatment with intramuscularly administered octreotide after gastrectomy or esophagectomy due to cancer |
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E.3 | Principal inclusion criteria |
•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.
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E.4 | Principal exclusion criteria |
•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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
•Weight loss in percent (%) from baseline weight before surgery, measured at 1, 2, 3, and 6 months after surgery (continuously).
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1,2,3 and 6 months after surgery |
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E.5.2 | Secondary end point(s) |
•Measurement of S-GLP-1, S-PYY, S-Ghrelin and S-GIP (prior to octreotide administration), measured at baseline, 7 days (±2 days) post-surgery and after 1 (±4 days), 2(±4 days), 3(±4 days), and 6 (±4 days) months.
•Body composition measured in percent (%) body fat (continuously) and with the questionnaires PG-SGA and EORTC CAX24.
•Health-related Quality of Life (HRQOL) measured using EORTC QLQ-C30 and QLQ-OG25, including esophageal cancer specific symptoms, at baseline and at 1, 2, 3 and 6 months after randomization.
•Percentage (of subjects) in need of enteral nutrition with a jejunostomy feeding catheter or nasogastric tube.
•Number and type of Adverse Events, including known AEs of Sandostatin LAR depot, such as biliary abnormalities, injection-site pain, nausea, abdominal pain, fatigue, headache, hyperglycemia, back pain, constipation or vomiting, dizziness, sinus bradycardia, pruritus, upper respiratory tract infection, myalgia, flatulence, arthropathy, rash, generalized pain, sinusitis, conduction abnormalities, hypoglycemia, and arrhythmia.
•Number of patients completing treatment.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1,2,3 and 6 months after surgery |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
No treatment with Sandostatin LAR |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of last subject
Substudy 1 will be completed before start of Substudy 2 |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |