Sandostatin (Octreotide LAR) May Lead to Clinical Improvement Through Receptor Occupation Optimisation

NCT04140409 | Terminated Phase 4 DMC

• 1 other identifier: SCIROCCO
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multi-centric prospective interventional study in which patients with a symptomatic GEP-NET will receive octreotide LAR every 2, 3 or 4 weeks. The basal dose and the dose adaptation will be left at the discretion of the investigator depending on the rate of symptom control. Dose increase up to doses of 60 mg octreotide every 4 weeks, or increase of frequency up to 30 mg every 2 weeks can be done to obtain control of carcinoid symptoms, defined by at least a 50% decrease of the mean number of bowel movements per day and the total number of flushes over 7 days AND a maximum frequency of less than 4 bowel movements a day. If only one symptom is present, analysis will be done for that symptom only: refer to table in statistical analysis The concentration of serum octreotide level will be realized with LCMS/MS following the method of Capron \& Wallemacq. Each blood sample should be taken 4 times per year just before the next injection of Octreotide LAR.

Conditions

Neuroendocrine Tumors; Carcinoid Syndrome

Keywords

NET

Outcome Measures

Primary Outcomes (1)

• Treatment succes vs treatment failure

  The primary endpoint is defined as follows: * Treatment success: Symptom control is achieved within 2 years of treatment with octreotide LAR. Symptom control is defined as at least a 50% decrease of the mean number of bowel movements per day and the total number of flushes over 7 days AND a maximum frequency of less than 4 bowel movements a day. * Treatment failure: No symptom control is achieved within 2 years of treatment with octreotide LAR. The response rate will be calculated as the number of patients with treatment success divided by the total number of included patients that received at least one injection of octreotide LAR.

  2 years

Secondary Outcomes (7)

• Symptoms

  2 years

• Rate of diarrhea and flushes

  2 years

• Impact of increased dose

  2 years

• Changes in Quality of life

  2 years

• Effect on tumor control

  2 years

Study Arms (1)

Treatment

EXPERIMENTAL

All patients will be treated with octreotide LAR intramuscular injections at maximum doses of 60 mg every 4 weeks or a frequency up to 30 mg octreotide LAR each 2 weeks. Change of dose or frequency is left at the discretion of the investigator until symptom control is obtained.

Drug: Sandostatin

Interventions

Sandostatin DRUG

All patients will be treated with octreotide LAR intramuscular injections at maximum doses of 60 mg every 4 weeks or a frequency up to 30 mg octreotide LAR each 2 weeks. Change of dose or frequency is left at the discretion of the investigator until symptom control is obtained.

Also known as: Octreotide LAR

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent GEP NET Ki 67 ≤ 10 %
• Histologically or cytologically confirmed GEP NET
• Evaluable or measurable disease (RECIST 1.1) WHO ECOG performance status 0-2
• Positive somatostatin receptor scintigraphy
• \>18 years
• Life expectancy of at least 12 weeks

You may not qualify if:

• Uncontrolled concurrent disease which prevents the adequate management and follow-up of the NET.
• Previous malignancy in the last past 3 years except malignancies estimated as completely cured.
• Current pregnancy or breast feeding
• Concomitant anti-tumoral treatment, except external beam radiotherapy

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

MeSH Terms

Conditions

Neuroendocrine Tumors; Serotonin Syndrome

Interventions

Octreotide

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Ivan Borbath, Prof

  Cliniques Universitaires St-Luc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: October 25, 2019
• Study Start: February 2, 2016
• Primary Completion: June 30, 2019
• Study Completion: September 19, 2019
• Last Updated: October 25, 2019

Record last verified: 2019-10