AcromegalyNCT00934271
Fractionated Stereotactic Radiotherapy in Patients With Acromegaly
An observational study of Acromegaly, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly
- What is being tested?
- fractionated stereotactic radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 34 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2002to Jan 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 34 patients with active acromegaly despite medical therapy
Who may be able to join
- adults active acromegaly pituitary tumour on MRI biochemical activity -
Who cannot join
- pregnancy no visible tumour on MRI
- -
Trial locations and contacts
1 site in 1 country.
Denmark1 site
National University Hospital, Department of Medical Endocrinology
Copenhagen, DK-2100
About this study
Official title: Fractionated Stereotactic Radiotherapy in Patients With Acromegaly. Single Centre Experience
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
- Conditions
- Acromegaly
- Being tested
- fractionated stereotactic radiotherapy
- Keywords
- acromegaly, irradiation, remission, pituitary function
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fractionated stereotactic radiotherapyRadiation
Audit of outcome
| Study group | Role | What they receive |
|---|---|---|
| Fractionated stereotactic radiotherapy | patients with active acromegaly Receives: Radiation: fractionated stereotactic radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumour control by pituitary MRI
Measured: 7 years
Secondary outcomes (3)
biochemical remission
Measured: 10 years
Affection of other pituitary axes
Measured: 10 years
withdrawal of somatostatin analogue and growth hormone receptor antagomist
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startJan 2002
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulla Feldt-Rasmussen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00934271
- Sponsor's protocol ID
- FSRT-SR-UFR
- Status last verified
- Oct 2014
- First submitted
- 7 Jul 2009
- Last updated
- 28 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractionated Stereotactic Radiotherapy in Patients With Acromegaly. Single Centre Experience
- ClinicalTrials.gov ID
- NCT00934271
- Acronym / sponsor ID
- FSRT-SR-UFR
- Conditions
- Acromegaly
- Keywords
- acromegaly, irradiation, remission, pituitary function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 8 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fractionated stereotactic radiotherapy | – | Radiation: fractionated stereotactic radiotherapypatients with active acromegaly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 34 patients with active acromegaly despite medical therapy
Key inclusion criteria (1 listed)
- adults active acromegaly pituitary tumour on MRI biochemical activity -
Key exclusion criteria (2 listed)
- pregnancy no visible tumour on MRI
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fractionated stereotactic radiotherapyAudit of outcome | Radiation | Fractionated stereotactic radiotherapy |
Primary outcome
Tumour control by pituitary MRI
Time frame: 7 years
3 secondary outcomes
biochemical remission
Time frame: 10 years
Affection of other pituitary axes
Time frame: 10 years
withdrawal of somatostatin analogue and growth hormone receptor antagomist
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acromegaly, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumour control by pituitary MRI (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2014.