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Completed

NCT Number: NCT00934271

Fractionated Stereotactic Radiotherapy in Patients With Acromegaly

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

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Key information

Conditions

Acromegaly Bone Diseases Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National University Hospital, Department of Medical Endocrinology

Copenhagen, DK-2100, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

adults active acromegaly pituitary tumour on MRI biochemical activity -

Exclusion criteria

pregnancy no visible tumour on MRI

-

Treatment and study plan

Fractionated Stereotactic Radiotherapy

Radiation

Audit of outcome

Primary outcomes

  1. Tumour control by pituitary MRI

    Time frame: 7 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

Fractionated Stereotactic Radiotherapy in Patients With Acromegaly. Single Centre Experience

Important dates

Study start
2002
Primary completion
2008
Study completion
2008
First posted
Jul 8, 2009
Registry last updated
Oct 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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