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Is treatment with octreotide effective in patients with head-and-neck paraganglioma?

Completed
Conditions
glomustumor
paraganglioma
10014710
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
Inclusion Criteria

-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

Exclusion Criteria

-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
NameTimeMethod
<p>1. tumorvolume<br /><br>2. catecholamine produktion </p><br>
Secondary Outcome Measures
NameTimeMethod
<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>
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