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

Phase 1
Conditions
Patients with head-and-neck paraganglioma
Registration Number
EUCTR2006-002603-13-NL
Lead Sponsor
eiden University Medical Center
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
30
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

-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)

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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