| 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 |
- Written informed consent
- GEP NET Ki 67 ≤ 2 %
- 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 Main 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
|
| 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 |