Clinical Trial: Fractionated Stereotactic Radiotherapy in Patients With Acromegaly

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Fractionated Stereotactic Radiotherapy in Patients With Acromegaly. Single Centre Experience

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 Summary: 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
Sponsor: Rigshospitalet, Denmark

Current Primary Outcome: Tumour control by pituitary MRI [ Time Frame: 7 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • biochemical remission [ Time Frame: 10 years ]
  • Affection of other pituitary axes [ Time Frame: 10 years ]
  • withdrawal of somatostatin analogue and growth hormone receptor antagomist [ Time Frame: 10 years ]


Original Secondary Outcome: Same as current

Information By: Rigshospitalet, Denmark

Dates:
Date Received: July 7, 2009
Date Started: January 2002
Date Completion:
Last Updated: October 26, 2014
Last Verified: October 2014