Is treatment with octreotide effective in patients with head-and-neck paraganglioma?
- Conditions
- glomustumorparaganglioma10014710
- Registration Number
- NL-OMON30072
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 4
-presence of one or more head-and-neck paraganglioma that grow fast (>/ 20%/year) and/or are complicated by recent cranial nerve palsy (<1 year ago)and/or production of catecholamines
-age 18-75 years
-positieve octreotidescan
-informed consent
-necessity for surgical resection 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 increased >3x)
-recent participation in other research projects (< 3 month's ago), or participation in >2 projects the past year
-(wish for) pregnancy
-presence of an adrenal tumor, suspect for phaeochromocytoma. These patients will be operated (adrenalectomy) first. In all other patients who participate, an MIBG scan and an MRI svan will be performed in case of overproduction of catecholamines
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. tumorvolume<br /><br>2. catecholamine produktion </p><br>
- Secondary Outcome Measures
Name Time Method <p>clinical and biochemical parameters (symptoms, related to the head-and-neck<br /><br>paraganglioma and/or additional catecholamine production, blood pressure and<br /><br>pulse rate, 24 hour blood pressure)</p><br>