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CompletedNCT00934271Updated Oct 28, 2014

Fractionated Stereotactic Radiotherapy in Patients With Acromegaly

An observational study in Acromegaly, sponsored by Copenhagen University Hospital, Rigshospitalet. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-10-28.

Sponsored by Copenhagen University Hospital, Rigshospitalet · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
34
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Acromegaly

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Keywords

  • acromegaly
  • irradiation
  • remission
  • pituitary function
03

In context

Acromegaly

203 studies on the registry are indexed under Acromegaly; 19 are open to participants now.

This study's enrollment of 34 is below the median of 100 across 81 observational studies indexed under Acromegaly.

Browse Acromegaly studies →

Lead sponsor

Copenhagen University Hospital, Rigshospitalet is the lead sponsor of 34 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

34 patients with active acromegaly despite medical therapy

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

adults active acromegaly pituitary tumour on MRI biochemical activity -

Exclusion criteria

Exclusion Criteria:

pregnancy no visible tumour on MRI

-

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
34 participants (actual)

Groups and cohorts

  • Fractionated stereotactic radiotherapy

    patients with active acromegaly

    Radiation: fractionated stereotactic radiotherapy

Interventions

  • Radiationfractionated stereotactic radiotherapy

    Audit of outcome

06

What researchers measure

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

07

Study locations

1 site
  • National University Hospital, Department of Medical Endocrinology
    Copenhagen, DK-2100, Denmark
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2002, a primary completion of Jan 2008 and a completion of Jan 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 7, 2009
First posted
Jul 8, 2009
Start
Jan 2002
Primary completionActual
Jan 2008
CompletionActual
Jan 2008
Last update
Oct 28, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 28, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00934271
Lead sponsor
Copenhagen University Hospital, Rigshospitalet
Responsible party
Ulla Feldt-Rasmussen (Professor, chief Physician, Copenhagen University Hospital, Rigshospitalet) — Principal investigator
First posted
Jul 8, 2009
Start date
Jan 2002
Primary completion
Jan 2008
Completion
Jan 2008
Last update
Oct 28, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

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