The primary objective is 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.
Conditions
Interventions
Trade Name: Sandostatine Long Acting Repeatable (LAR) 10, 20, 30 mg
Product Name: SANDOSTATIN LAR
Pharmaceutical Form: Injection
Sponsors
Cliniques Universitaires Saint Luc
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is 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 Objective: - 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;Primary end point(s): 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. ;Timepoint(s) of evaluation of this end point: Study timelines: Enrolment start date (FPI): 12/2015 Enrolment finish date (LPI): 12/2018 Treatment period end date (LP off treatment): 12/2020 Follow-up period end date (LP off study): 2 years Planned date for primary analysis: 12/2020 Planned date for final analysis: 12/2021 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - 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. ;Timepoint(s) of evaluation of this end point: Planned date for final analysis: 12/2021 | — |
Countries
Belgium
Contacts
Public ContactMicheline Stempin
BGDO vzw
Outcome results
None listed