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Fractionated Stereotactic Radiotherapy in Patients With Acromegaly

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ClinicalTrials.gov Identifier: NCT00934271
Recruitment Status : Completed
First Posted : July 8, 2009
Last Update Posted : October 28, 2014
Sponsor:
Information provided by (Responsible Party):
Ulla Feldt-Rasmussen, 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

Condition or disease Intervention/treatment
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

Study Type : Observational
Actual Enrollment : 34 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Fractionated Stereotactic Radiotherapy in Patients With Acromegaly. Single Centre Experience
Study Start Date : January 2002
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Fractionated stereotactic radiotherapy
patients with active acromegaly
Radiation: fractionated stereotactic radiotherapy
Audit of outcome




Primary Outcome Measures :
  1. Tumour control by pituitary MRI [ Time Frame: 7 years ]

Secondary Outcome Measures :
  1. biochemical remission [ Time Frame: 10 years ]
  2. Affection of other pituitary axes [ Time Frame: 10 years ]
  3. withdrawal of somatostatin analogue and growth hormone receptor antagomist [ Time Frame: 10 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00934271


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

Responsible Party: Ulla Feldt-Rasmussen, Professor, chief Physician, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT00934271     History of Changes
Other Study ID Numbers: FSRT-SR-UFR
First Posted: July 8, 2009    Key Record Dates
Last Update Posted: October 28, 2014
Last Verified: October 2014

Keywords provided by Ulla Feldt-Rasmussen, 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