Fractionated Stereotactic Radiotherapy in Patients With Acromegaly

Completed

• Conditions: Acromegaly
• Interventions: Radiation: fractionated stereotactic radiotherapy

• Registration Number: NCT00934271
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2002-01
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Study First Submitted: 2009-07-07
• Study First Submitted QC: 2009-07-07
• Study First Posted: 2009-07-08
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-26
• Last Update Posted: 2014-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

adults active acromegaly pituitary tumour on MRI biochemical activity -

Exclusion Criteria

pregnancy no visible tumour on MRI

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fractionated stereotactic radiotherapy	fractionated stereotactic radiotherapy	patients with active acromegaly

Primary Outcome Measures

Name	Time	Method
Tumour control by pituitary MRI	7 years

Secondary Outcome Measures

Name	Time	Method
biochemical remission	10 years
withdrawal of somatostatin analogue and growth hormone receptor antagomist	10 years
Affection of other pituitary axes	10 years

Trial Locations

Locations (1)

National University Hospital, Department of Medical Endocrinology; 🇩🇰 Copenhagen, Denmark