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Fractionated Stereotactic Radiotherapy in Patients With Acromegaly

NCT ID: NCT00934271

Last Updated: 2014-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-01-31

Study Completion Date

2008-01-31

Brief Summary

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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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Detailed Description

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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

Conditions

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Acromegaly

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Fractionated stereotactic radiotherapy

patients with active acromegaly

fractionated stereotactic radiotherapy

Intervention Type RADIATION

Audit of outcome

Interventions

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fractionated stereotactic radiotherapy

Audit of outcome

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

adults active acromegaly pituitary tumour on MRI biochemical activity -

Exclusion Criteria

pregnancy no visible tumour on MRI

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Ulla Feldt-Rasmussen

Professor, chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National University Hospital, Department of Medical Endocrinology

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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FSRT-SR-UFR

Identifier Type: -

Identifier Source: org_study_id

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