SCIROCCO Trial

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

Trial Status Recruiting
Phase Phase IV
Type of cancer Neuro-endocrine tumors with carcinoid syndrome
Study design

Prospective, interventional, multicentric

Objectives

Primary

  • To observe the change from baseline in the incidence of diarrhea and flushing in correlation to the serum octreotide level, independently of the dose variations of octreotide LAR.

Secondary

  • To describe the number of symptoms in correlation to the serum octreotide level, defined by a blood level test of octreotide.
  • To describe the rate of diarrhea and flushing via a patient diary
  • To describe the impact of increased dose of octreotide LAR on the symptoms: bowel movements and flushing (via patient diary)
  • To describe the effect of Octreotide LAR on Quality of Life, based on the change from baseline in the OLO-GINET21 scores
  • To describe the effect of Octreotide LAR on tumor control according to RECIST 1.1 criteria
  • To describe the safety of octreotide (CTCAE grades)
  • To describe the correlation between the dose/frequency of octreotide LAR given and the serum octreotide level
Inclusion Main criteria
  1. Written informed consent
  2. GEP NET Ki 67 ≤ 2 %
  3. Histologically or cytologically confirmed GEP NET
  4. Appearance of carcinoid syndrome maximum 6 months before the inclusion
  5. Evaluable or measurable disease (RECIST 1.1)
  6. WHO ECOG performance status 0-2
  7. Positive somatostatin receptor scintigraphy
  8. >18 years
  9. Life expectancy of at least 12 weeks
Exclusion Main criteria
  1. Uncontrolled concurrent disease which prevents the adequate management and follow-up of the NET.
  2. Previous malignancy in the last past 3 years except malignancies estimated as completely cured.
  3. Current pregnancy or breast feeding
  4. Concomitant anti-tumoral treatment, except external beam radiotherapy
Treatment schedule

Baseline dose: 20 or 30 mg, left at the discretion of the investigator

Dose increase: the dose and/or frequency of octreotide LAR injections can be increased up to a maximum of 60 mg/4 weeks or a frequency of injection of 30 mg/2 weeks.

Study Period

First inclusion: January 2017

Planned end recruitment: Dec 2017 (amendment to increase the recruitment period ongoing)

Planned last patient last visit: Dec 2019

Study Coordinators

Cliniques Universitaires Saint Luc Brussels, Prof. Dr. I. Borbath

Participating Groups

Not applicable

Participating centres

UCL St-Luc
CH Jolimont
UZ Antwerpen
Cliniques St-Pierre Ottignies
UZ Gent
ULB Erasme
Imelda Bonheiden
ZNA Jan Palfijn
AZ Delta
AZ St-Maarten
AZ St-Jan Brugge

Protocol summary Link to ClinicalTrials.gov
NCT number
EudraCT 2014-003856-30
Interest to participate clinicaltrials@bgdo.org
More info clinicaltrials@bgdo.org