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NCT00934271 Clinical Trial

Fractionated Stereotactic Radiotherapy in Patients With Acromegaly

Acromegaly Clinical Trial

Official title:
Fractionated Stereotactic Radiotherapy in Patients With Acromegaly. Single Centre Experience

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00934271
Other study ID # FSRT-SR-UFR
Secondary ID
Status Completed
Phase N/A
First received July 7, 2009
Last updated October 26, 2014
Start date January 2002
Est. completion date January 2008

Study information
Verified date October 2014
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection Agency
Study type Observational

Clinical Trial Summary

Hypothesis: Fractionated stereotactic radiotherapy is a safe therapy for treatment of patients with acromegaly in terms of both tumour control and biochemical remission

Description:

An audit was done on 34 patients with acromegaly (consecutive cohorte) treated with fractionated stereotactic radiotherapy in Rigshospitalet/National University Hospital, Copenhagen, Denmark. All patients had MR control regularly to monitor tunour control, and biochemical control assessed by growth hormone measurements during an oral glucose tolerance test. Furthermore all other pituitary axes were tested for sufficiency and concomitant medication likewise registered. The 7 year interim analysis demonstrated an acceptable tumour control and biochemical remission profile, and most patient had subsequent withdrawal of somatostatin analogue- and growth hormone receptor antagonis therapy. The observational study will continue with a new update in approx 2 years

Recruitment information / eligibility
Status Completed
Enrollment 34
Est. completion date January 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

adults active acromegaly pituitary tumour on MRI biochemical activity -

Exclusion Criteria:

pregnancy no visible tumour on MRI

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Radiation:
• fractionated stereotactic radiotherapy
Audit of outcome

Locations
Country Name City State
Denmark National University Hospital, Department of Medical Endocrinology Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Tumour control by pituitary MRI 7 years No
Secondary biochemical remission 10 years No
Secondary Affection of other pituitary axes 10 years Yes
Secondary withdrawal of somatostatin analogue and growth hormone receptor antagomist 10 years Yes
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Recruiting NCT04520646 - A Pilot Study of Empagliflozin in the Treatment of Acromegalic Cardiomyopathy N/A
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Active, not recruiting NCT03252353 - Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly Phase 3