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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Karolinska University Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

17 Nov 2020 → 21 Feb 2024

Decision date (initial)

2022-12-20

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2022-502745-98-00

EudraCT number

2019-001200-38

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

To determine if intramuscularly administered octreotide can decrease weight loss after gastrectomy or esophagectomy due to cancer.

Secondary objectives 5

1. To study if octreotide treatment affects the levels of gastrointestinal satiety hormones
2. To determine if octreotide treatment affects body composition
3. To determine if octreotide treatment affects postoperative health related quality of life
4. To study if postoperative eating problems can be reduced by intramuscular administration of octreotide
5. To study safety and tolerability of treatment with intramuscularly administered octreotide after gastrectomy or esophagectomy due to cancer

Conditions and MedDRA coding

Esophageal and gastric cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Pathologic anatomic analysis (PAD) confirmed esophageal or gastric cancer
2. Gastrectomy or esophagectomy with curative intent
3. ≥18 years of age
4. Signed informed consent
5. Able to comply with the procedures of the study protocol, in the opinion of the investigator
6. 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.

Exclusion criteria 13

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Weight loss in percent (%) from baseline weight before surgery, measured at 1, 2, 3, and 6 months after surgery (continuously).

Secondary endpoints 6

1. 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.
2. Body composition measured in percent (%) body fat (continuously) and with the questionnaires PG-SGA and EORTC CAX24.
3. 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.
4. Percentage (of subjects) in need of enteral nutrition with a jejunostomy feeding catheter or nasogastric tube
5. 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.
6. Number of patients completing treatment.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Karolinska University Hospital

Sponsor organisation

Karolinska University Hospital

Address

Eugeniavagen 3

City

Solna

Postcode

171 64

Country

Sweden

Scientific contact point

Organisation

Karolinska University Hospital

Contact name

Fredrik Klevebro

Public contact point

Organisation

Karolinska University Hospital

Contact name

Fredrik Klevebro

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 2 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications