Fractionated Stereotactic Radiotherapy in Patients With Acromegaly

This study has been completed.
Information provided by (Responsible Party):
Ulla Feldt-Rasmussen, Rigshospitalet, Denmark Identifier:
First received: July 7, 2009
Last updated: October 26, 2014
Last verified: October 2014

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

Condition Intervention
Radiation: fractionated stereotactic radiotherapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Fractionated Stereotactic Radiotherapy in Patients With Acromegaly. Single Centre Experience

Resource links provided by NLM:

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Tumour control by pituitary MRI [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • biochemical remission [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Affection of other pituitary axes [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • withdrawal of somatostatin analogue and growth hormone receptor antagomist [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Enrollment: 34
Study Start Date: January 2002
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Fractionated stereotactic radiotherapy
patients with active acromegaly
Radiation: fractionated stereotactic radiotherapy
Audit of outcome

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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

34 patients with active acromegaly despite medical therapy


Inclusion Criteria:

adults active acromegaly pituitary tumour on MRI biochemical activity -

Exclusion Criteria:

pregnancy no visible tumour on MRI

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Please refer to this study by its identifier: NCT00934271

National University Hospital, Department of Medical Endocrinology
Copenhagen, Denmark, DK-2100
Sponsors and Collaborators
Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Ulla Feldt-Rasmussen, Professor, chief Physician, Rigshospitalet, Denmark Identifier: NCT00934271     History of Changes
Other Study ID Numbers: FSRT-SR-UFR
Study First Received: July 7, 2009
Last Updated: October 26, 2014
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Rigshospitalet, Denmark:
pituitary function

Additional relevant MeSH terms:
Bone Diseases
Bone Diseases, Endocrine
Brain Diseases
Central Nervous System Diseases
Endocrine System Diseases
Hypothalamic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Pituitary Diseases processed this record on October 08, 2015