NCT00934271

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 8, 2009

Completed
Last Updated

October 28, 2014

Status Verified

October 1, 2014

Enrollment Period

6 years

First QC Date

July 7, 2009

Last Update Submit

October 26, 2014

Conditions

Acromegaly

Keywords

acromegalyirradiationremissionpituitary function

Outcome Measures

Primary Outcomes (1)

  • Tumour control by pituitary MRI

    7 years

Secondary Outcomes (3)

  • biochemical remission

    10 years

  • Affection of other pituitary axes

    10 years

  • withdrawal of somatostatin analogue and growth hormone receptor antagomist

    10 years

Study Arms (1)

Fractionated stereotactic radiotherapy

patients with active acromegaly

Radiation: fractionated stereotactic radiotherapy

Interventions

fractionated stereotactic radiotherapyRADIATION

Audit of outcome

Fractionated stereotactic radiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

34 patients with active acromegaly despite medical therapy

You may qualify if:

  • adults active acromegaly pituitary tumour on MRI biochemical activity -

You may not qualify if:

  • pregnancy no visible tumour on MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital, Department of Medical Endocrinology

Copenhagen, DK-2100, Denmark

Location

MeSH Terms

Conditions

Acromegaly

Condition Hierarchy (Ancestors)

Bone Diseases, EndocrineBone DiseasesMusculoskeletal DiseasesHyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, chief Physician

Study Record Dates

First Submitted

July 7, 2009

First Posted

July 8, 2009

Study Start

January 1, 2002

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

October 28, 2014

Record last verified: 2014-10

Locations

DK(1)