Trial for patients with neuro-endocrine tumors with carcinoid syndrome receiving octreotide LAR.
- Conditions
- 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.Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-003856-30-BE
- Lead Sponsor
- Cliniques Universitaires Saint Luc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
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
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 & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method