Fractionated Stereotactic Radiotherapy in Patients With Acromegaly

Fractionated Stereotactic Radiotherapy in Patients With Acromegaly. Single Centre Experience

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

Study Overview

• Status: Completed
• Conditions: Acromegaly
• Intervention / Treatment: 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
• Enrollment (Actual): 34

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, DK-2100
    • National University Hospital, Department of Medical Endocrinology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

34 patients with active acromegaly despite medical therapy

Description

Inclusion Criteria:

adults active acromegaly pituitary tumour on MRI biochemical activity -

Exclusion Criteria:

pregnancy no visible tumour on MRI

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Tumour control by pituitary MRI	7 years

Secondary Outcome Measures

Outcome Measure	Time Frame
biochemical remission	10 years
Affection of other pituitary axes	10 years
withdrawal of somatostatin analogue and growth hormone receptor antagomist	10 years

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start: January 1, 2002
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: July 7, 2009
• First Submitted That Met QC Criteria: July 7, 2009
• First Posted (Estimate): July 8, 2009

Study Record Updates

• Last Update Posted (Estimate): October 28, 2014
• Last Update Submitted That Met QC Criteria: October 26, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: remission; irradiation; acromegaly; pituitary function
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Musculoskeletal Diseases; Hypothalamic Diseases; Bone Diseases; Bone Diseases, Endocrine; Hyperpituitarism; Pituitary Diseases; Acromegaly
• Other Study ID Numbers: FSRT-SR-UFR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No