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

Sandostatin (Octreotide LAR) May Lead to Clinical Improvement Through Receptor Occupation Optimisation A Prospective Interventional Trial of Patients With Neuro-endocrine Tumors With Carcinoid Syndrome Receiving Octreotide LAR

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.

Study Overview

• Status: Terminated
• Conditions: Neuroendocrine Tumors; Carcinoid Syndrome
• Intervention / Treatment: Drug: Sandostatin

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Written informed consent GEP NET Ki 67 ≤ 10 %
• Histologically or cytologically confirmed GEP NET
• Appearance of carcinoid syndrome maximum 6 months before the inclusion
• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; 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; 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.; Other Names: Octreotide LAR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms	To describe the number of symptoms in correlation to the serum octreotide level, defined by a blood level test of octreotide.	2 years
Rate of diarrhea and flushes	To describe the rate of diarrhea and flushing via a patient diary	2 years
Impact of increased dose	To describe the impact of increased dose of octreotide LAR on the symptoms: bowel movements and flushing (via patient diary).	2 years
Changes in Quality of life	To describe the effect of Octreotide LAR on Quality of Life, based on the change from baseline in the OLO-GINET21 scores	2 years
Effect on tumor control	To describe the effect of Octreotide LAR on tumor control according to RECIST 1.1 criteria •	2 years
Toxicities	To describe the safety of octreotide (CTCAE grades)	2 years
Correlation dose/frequency	To describe the correlation between the dose/frequency of octreotide LAR given and the serum octreotide level.	2 years

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Investigators: Principal Investigator: Ivan Borbath, Prof, Cliniques Universitaires St-Luc

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2016
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): September 19, 2019

Study Registration Dates

• First Submitted: October 22, 2019
• First Submitted That Met QC Criteria: October 24, 2019
• First Posted (Actual): October 25, 2019

Study Record Updates

• Last Update Posted (Actual): October 25, 2019
• Last Update Submitted That Met QC Criteria: October 24, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: NET
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Disease; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Drug-Related Side Effects and Adverse Reactions; Syndrome; Neuroendocrine Tumors; Carcinoid Tumor; Malignant Carcinoid Syndrome; Serotonin Syndrome; Antineoplastic Agents; Gastrointestinal Agents; Antineoplastic Agents, Hormonal; Octreotide
• Other Study ID Numbers: SCIROCCO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No