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Fractionated Stereotactic Radiotherapy in Patients With Acromegaly

This study has been completed.
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00934271
First received: July 7, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

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
Acromegaly
 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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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

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

  Eligibility

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

Criteria

Inclusion Criteria:

adults active acromegaly pituitary tumour on MRI biochemical activity -

Exclusion Criteria:

pregnancy no visible tumour on MRI

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00934271

Locations
Denmark
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, National University Hospital
ClinicalTrials.gov Identifier: NCT00934271     History of Changes
Other Study ID Numbers: FSRT-SR-UFR
Study First Received: July 7, 2009
Last Updated: July 7, 2009
Health Authority: Audit of a new practice. Approved by University Hospital, Copenhagen, Denmark: no other approval required

Keywords provided by Rigshospitalet, Denmark:
acromegaly
irradiation
remission
pituitary function

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
 Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 22, 2013