Patients with head-and-neck paraganglioma
Conditions
Interventions
Trade Name: Sandostatine LAR
Pharmaceutical Form:
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: -presence of one or more paragangliomen/glomustumors in the head-and-neck area that grow fast (>/ 20%/year) and/or are complicated by cranial nerve palsy and/or production of catecholamines -age 18-75 years -positive octreotide scan -informed consent 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria: -necessity for surgical intervention of the head-and-neck paraganglioma -presence of additional paraganglioma in the thorax or abdomen -presence of metastases of the head-and-neck paraganglioma -cholelithiasis -diabetes mellitus -severe renal insufficiency (creatinine > 150 micromol/L), or liver failure(ALAT and/or ASAT >3x increased)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the effects of octreotide LAR in head-and-neck paraganglioma on: 1. tumor volume 2. catecholamine produktion ;Secondary Objective: Evaluation of the effects of octreotide LAR in head-and-neck paraganglioma on: clinical and biochemical parameters ;Primary end point(s): 1. tumor volume 2. catecholamine produktion | — |
Countries
Netherlands
Outcome results
None listed