Fractionated Stereotactic Radiotherapy in Patients With Acromegaly

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Acromegaly
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Novartis Pharmaceuticals – Acromegaly
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Brief Title

Fractionated Stereotactic Radiotherapy in Patients With Acromegaly

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 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

Primary Outcome

Tumour control by pituitary MRI

Secondary Outcome

 biochemical remission

Condition

Acromegaly

Intervention

fractionated stereotactic radiotherapy

Study Arms / Comparison Groups

 Fractionated stereotactic radiotherapy
Description:  patients with active acromegaly

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Radiation

Estimated Enrollment

34

Start Date

January 2002

Completion Date

January 2008

Primary Completion Date

January 2008

Eligibility Criteria

        Inclusion Criteria:

        adults active acromegaly pituitary tumour on MRI biochemical activity -

        Exclusion Criteria:

        pregnancy no visible tumour on MRI

        -

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations

NCT ID

NCT00934271

Organization ID

FSRT-SR-UFR

Responsible Party

Principal Investigator

Study Sponsor

Rigshospitalet, Denmark

Study Sponsor

, ,

Verification Date

October 2014