Brain TumorPhase 3NCT00181350
Serial CT Scans in Fractionated Stereotactic Radiotherapy
A Phase 3 study testing Relocatable fixation system in people with Brain Tumor, run by Maastricht Radiation Oncology at 1 site in Netherlands.
Trial summary
This study aims at providing a quantitative evaluation of the accuracy of two different fixation systems, where one system is also evaluated with two different set-ups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor
- What is being tested?
- Relocatable fixation system
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2003to Jul 2007
- Phase
- Phase 3
- 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
Who may be able to join
- Clinical diagnosis of brain tumor
- Fractionated stereotactic radiotherapy
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serial CT Scans for the Evaluation of Two Different Relocatable Fixation Systems in Fractionated Stereotactic Radiotherapy
This study aims at providing a quantitative evaluation of the accuracy of two different fixation systems, where one system is also evaluated with two different set-ups.
Read the detailed description
Stereotactic conformal radiotherapy (SCRT) combines the precision of the stereotactically guided tumor localisation and the radiobiological advantages of the fractionation. This implies an highly accurate repositioning of the isocenter of the cerebral target at the isocenter of the linac gantry and couch + 30 times. In the use of stereotactic conformal radiotherapy (SCRT) accuracy is the mainstay for the treatment of brain tumours. The reason are reduced safety margins around the tumour (or no margins) in order to reduce normal tissue dose.
This study aims at providing a quantitative evaluation of the accuracy of two different fixation systems, where one system is also evaluated with two different set-ups. The first approach will be based on the BrainLAB thermoplastic masque (the masque with (= standard fixation) and without a custom made bite-block), the second will use the BrianLAB relocatable frame with the bite- block and a home made fixation system.
Repositioning accuracy will be evaluated in a randomized manner patient-dependent and independent with the two fixation systems mentioned above.
The rationale is to determine the margins to define the planning target volume (PTV), it is necessary to know the set-up accuracy of the immobilization system. An overestimation of the PTV would lead to possible toxicity and an underestimation could lead to a geographical miss.
The main endpoint of this trial will be the accurate reproducibility of the fixation system evaluated by repeated CT scan.
- Conditions
- Brain Tumor
- Being tested
- Relocatable fixation system
- Keywords
- brain tumor, fractionated stereotactic radiotherapy, fixationsystems, repositioning
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relocatable fixation systemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
CT scanning with a stereotactic lokalizer will take place once a week with a double scan (for 2 fixations) without contrast.
Secondary outcomes (1)
No secondary measures.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startNov 2003
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University Medical Center
- Investigators
- Brigitta Baumert, PHD, Principal investigator, Maastricht Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00181350
- Sponsor's protocol ID
- P03.1426L
- Status last verified
- Jun 2009
- First submitted
- 9 Sep 2005
- Last updated
- 30 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Theelen A, Martens J, Bosmans G, Houben R, Jager JJ, Rutten I, Lambin P, Minken AW, Baumert BG. Relocatable fixation systems in intracranial stereotactic radiotherapy. Accuracy of serial CT scans and patient acceptance in a randomized design. Strahlenther Onkol. 2012 Jan;188(1):84-90. doi: 10.1007/s00066-011-0018-7. Epub 2011 Dec 24.
PubMed 22194025
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial CT Scans for the Evaluation of Two Different Relocatable Fixation Systems in Fractionated Stereotactic Radiotherapy
- ClinicalTrials.gov ID
- NCT00181350
- Acronym / sponsor ID
- P03.1426L
- Conditions
- Brain Tumor
- Keywords
- brain tumor, fractionated stereotactic radiotherapy, fixationsystems, repositioning
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Collaborators
- Maastricht University Medical Center
- Study start
- Nov 2003
- Study completion
- Jul 2007 (actual)
- First posted
- 16 Sep 2005 (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.
This study aims at providing a quantitative evaluation of the accuracy of two different fixation systems, where one system is also evaluated with two different set-ups.
Detailed description
Stereotactic conformal radiotherapy (SCRT) combines the precision of the stereotactically guided tumor localisation and the radiobiological advantages of the fractionation. This implies an highly accurate repositioning of the isocenter of the cerebral target at the isocenter of the linac gantry and couch + 30 times. In the use of stereotactic conformal radiotherapy (SCRT) accuracy is the mainstay for the treatment of brain tumours. The reason are reduced safety margins around the tumour (or no margins) in order to reduce normal tissue dose.
This study aims at providing a quantitative evaluation of the accuracy of two different fixation systems, where one system is also evaluated with two different set-ups. The first approach will be based on the BrainLAB thermoplastic masque (the masque with (= standard fixation) and without a custom made bite-block), the second will use the BrianLAB relocatable frame with the bite- block and a home made fixation system.
Repositioning accuracy will be evaluated in a randomized manner patient-dependent and independent with the two fixation systems mentioned above.
The rationale is to determine the margins to define the planning target volume (PTV), it is necessary to know the set-up accuracy of the immobilization system. An overestimation of the PTV would lead to possible toxicity and an underestimation could lead to a geographical miss.
The main endpoint of this trial will be the accurate reproducibility of the fixation system evaluated by repeated CT scan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of brain tumor
- Fractionated stereotactic radiotherapy
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Relocatable fixation system | Device | – |
Primary outcome
CT scanning with a stereotactic lokalizer will take place once a week with a double scan (for 2 fixations) without contrast.
1 secondary outcome
No secondary measures.
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 30 Jun 2009.
- Derived from this study: PubMed 22194025Theelen A, Martens J, Bosmans G, Houben R, Jager JJ, Rutten I, Lambin P, Minken AW, Baumert BG. Relocatable fixation systems in intracranial stereotactic radiotherapy. Accuracy of serial CT scans and patient acceptance in a randomized design. Strahlenther Onkol. 2012 Jan;188(1):84-90. doi: 10.1007/s00066-011-0018-7. Epub 2011 Dec 24.
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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.
Brigitta Baumert, PHD principal investigator
Maastricht Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Relocatable fixation system in people with Brain Tumor, run by Maastricht Radiation Oncology at 1 site in Netherlands.
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 2 inclusion and 1 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 30 Jun 2009. 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 Netherlands. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
CT scanning with a stereotactic lokalizer will take place once a week with a double scan (for 2 fixations) without contrast.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00181350, which also lists 1 linked publication.
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 30 Jun 2009.