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

Short name SCIROCCO

NCTNCT04140409Other idSCIROCCO

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Slow recruitment

Overview

Status: Terminated
Phase: Phase 4
Enrollment: 10 participants (actual)
Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Other
Design: Allocation not applicable · Open label (no masking)
Countries: Not stated
Start: 2 Feb 2016
Primary completion: 30 Jun 2019
Completion: 19 Sept 2019
First posted: 25 Oct 2019
Last update posted: 25 Oct 2019
Conditions: Neuroendocrine Tumors · Carcinoid Syndrome

Timeline

1 trial · 1 stopped early

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20162017201820192020

Ph 4
SCIROCCO
NCT04140409
2 Feb 2016 to 19 Sept 2019
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

SandostatinDrug

Arms1

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.

Primary outcomes1

Outcomes the sponsor listed as primary.

Treatment succes vs treatment failure
Time frame · 2 years
Registry description
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.

Secondary outcomes(7)

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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