Patients Receiving Fractionated Stereotactic RadiotherapyPhase 3NCT00328510
Comparing Two Forms of Head Immobilization for Stereotactic Radiotherapy
A Phase 3 study testing GTC frame, Thermoplastic facemask and Stereotactic radiation therapy in people with Patients Receiving Fractionated Stereotactic Radiotherapy and for Brain Tumors, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial summary
Fractionated stereotactic radiotherapy (SRT) requires extremely precise and reproducible immobilization of the patient's head. This randomized study compares the efficacy of two commonly used forms of immobilization used for SRT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Receiving Fractionated Stereotactic Radiotherapy, for Brain Tumors
- What is being tested?
- GTC frame, Thermoplastic facemask and Stereotactic radiation therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Sep 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients who are eligible for fractionated stereotactic radiotherapy
Who cannot join
- Severe claustrophobia
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Randomized Trial Comparing Two Forms of Immobilization of the Head for Fractioned Stereotactic Radiotherapy
Fractionated stereotactic radiotherapy (SRT) requires extremely precise and reproducible immobilization of the patient's head. This randomized study compares the efficacy of two commonly used forms of immobilization used for SRT.
Read the detailed description
PRIMARY OBJECTIVE:
- To compare the efficacy of two commonly used, generally accepted forms of immobilization for the treatment of lesions in the head with fractionated stereotactic radiotherapy. Specifically, this study will use the ExacTRAC kilovoltage imaging system to assess positioning accuracy for these two systems.
OUTLINE:
Two routinely used methods of immobilization, which differ in their approach to reproduce head position from day-to-day are the Gill-Thomas-Cosman (GTC)frame and the BrainLab thermoplastic mask. The GTC frame fixates on the patient upper detention and thus us in direct mechanical contact with the cranium. The BrainLab mask is a two-part masking system custom-fitted to the front and back of the participant's head. After patients sign an IRB-approved informed consent form, eligible participants are either randomized to either the GTC frame or the mask for their course of SRT. Participants are treated as per standard procedure; however, prior to each treatment, a set of digital kV images (ExacTrac, BrainLabAB, Germany) is taken. These images are fused with reference digitally constructed radiographs obtained from treatment planning CT to yield lateral, longitudinal, and vertical deviations of isocenter and head rotations about respective axes. The primary endpoint of the study is to compare the two systems with respect to mean and standard deviations (SDs) using the distance to isocenter measure.
- Being tested
- GTC frame, Thermoplastic facemask, Stereotactic radiation therapy
- Keywords
- Stereotactic radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GTC frameDevice
Thermoplastic facemaskDevice
Stereotactic radiation therapyRadiation
Also called SRT
| Study group | Role | What they receive |
|---|---|---|
| GTC Frame | Experimental | Participant undergoes SRT using a GTC frame to immobilize the participant's heading during radiation therapy Receives: Device: GTC frame; Radiation: Stereotactic radiation therapy |
| BrainLab thermoplastic mask | Experimental | Participant undergoes SRT using the BrainLab thermoplastic mask to immobilize the participant's head during radiation therapy Receives: Device: Thermoplastic facemask; Radiation: Stereotactic radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance From Ideal to Center of GTC Frame and BrainLab Thermoplastic Mask With Respect to Average and Variability
This study uses the ExacTRAC imaging system to assess positioning of frame or mask during SRT. Images yield lateral, longitudinal, and vertical deviations of the isocenter as well as head rotations about respective axes.
Measured: Measurements taken during SRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2006 (estimated)
- Study startFeb 2005
- Primary completionJan 2008
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Patients Receiving Fractionated Stereotactic RadiotherapyStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Werner-Wasik, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00328510
- Sponsor's protocol ID
- 04U.534
- Other IDs
- 2004-72
- Status last verified
- Oct 2016
- First submitted
- 19 May 2006
- Last updated
- 29 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Shiu A, Parker B, Ye JS, Lii J. An integrated treatment delivery system for CSRS and CSRT and clinical applications. J Appl Clin Med Phys. 2003 Autumn;4(4):261-73. doi: 10.1120/jacmp.v4i4.2496.
PubMed 14604415Burton KE, Thomas SJ, Whitney D, Routsis DS, Benson RJ, Burnet NG. Accuracy of a relocatable stereotactic radiotherapy head frame evaluated by use of a depth helmet. Clin Oncol (R Coll Radiol). 2002 Feb;14(1):31-9. doi: 10.1053/clon.2001.0001.
PubMed 11898783Lopatta E, Liesenfeld SM, Bank P, Wurm R, Gunther R, Wiezorek T, Wendt TG. [Improved patient repositioning accuracy by integrating an additional jaw fixation into a high precision face mask system in stereotactic radiotherapy of the head]. Strahlenther Onkol. 2003 Aug;179(8):571-5. doi: 10.1007/s00066-003-0941-3. German.
PubMed 14509957
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing Two Forms of Immobilization of the Head for Fractioned Stereotactic Radiotherapy
- ClinicalTrials.gov ID
- NCT00328510
- Acronym / sponsor ID
- 04U.534
- Keywords
- Stereotactic radiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 22 May 2006 (estimated)
- Results
- Posted 19 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fractionated stereotactic radiotherapy (SRT) requires extremely precise and reproducible immobilization of the patient's head. This randomized study compares the efficacy of two commonly used forms of immobilization used for SRT.
Detailed description
PRIMARY OBJECTIVE:
- To compare the efficacy of two commonly used, generally accepted forms of immobilization for the treatment of lesions in the head with fractionated stereotactic radiotherapy. Specifically, this study will use the ExacTRAC kilovoltage imaging system to assess positioning accuracy for these two systems.
OUTLINE:
Two routinely used methods of immobilization, which differ in their approach to reproduce head position from day-to-day are the Gill-Thomas-Cosman (GTC)frame and the BrainLab thermoplastic mask. The GTC frame fixates on the patient upper detention and thus us in direct mechanical contact with the cranium. The BrainLab mask is a two-part masking system custom-fitted to the front and back of the participant's head. After patients sign an IRB-approved informed consent form, eligible participants are either randomized to either the GTC frame or the mask for their course of SRT. Participants are treated as per standard procedure; however, prior to each treatment, a set of digital kV images (ExacTrac, BrainLabAB, Germany) is taken. These images are fused with reference digitally constructed radiographs obtained from treatment planning CT to yield lateral, longitudinal, and vertical deviations of isocenter and head rotations about respective axes. The primary endpoint of the study is to compare the two systems with respect to mean and standard deviations (SDs) using the distance to isocenter measure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GTC Frame | Experimental | Device: GTC frame, Radiation: Stereotactic radiation therapyParticipant undergoes SRT using a GTC frame to immobilize the participant's heading during radiation therapy |
| BrainLab thermoplastic mask | Experimental | Device: Thermoplastic facemask, Radiation: Stereotactic radiation therapyParticipant undergoes SRT using the BrainLab thermoplastic mask to immobilize the participant's head during radiation therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are eligible for fractionated stereotactic radiotherapy
Key exclusion criteria (1 listed)
- Severe claustrophobia
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 |
|---|---|---|
| GTC frame | Device | GTC Frame |
| Thermoplastic facemask | Device | BrainLab thermoplastic mask |
| Stereotactic radiation therapyAlso: SRT | Radiation | BrainLab thermoplastic mask, GTC Frame |
Primary outcome
Distance From Ideal to Center of GTC Frame and BrainLab Thermoplastic Mask With Respect to Average and Variability
Time frame: Measurements taken during SRT
This study uses the ExacTRAC imaging system to assess positioning of frame or mask during SRT. Images yield lateral, longitudinal, and vertical deviations of the isocenter as well as head rotations about respective axes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 14604415Shiu A, Parker B, Ye JS, Lii J. An integrated treatment delivery system for CSRS and CSRT and clinical applications. J Appl Clin Med Phys. 2003 Autumn;4(4):261-73. doi: 10.1120/jacmp.v4i4.2496.
- Background: PubMed 11898783Burton KE, Thomas SJ, Whitney D, Routsis DS, Benson RJ, Burnet NG. Accuracy of a relocatable stereotactic radiotherapy head frame evaluated by use of a depth helmet. Clin Oncol (R Coll Radiol). 2002 Feb;14(1):31-9. doi: 10.1053/clon.2001.0001.
- Background: PubMed 14509957Lopatta E, Liesenfeld SM, Bank P, Wurm R, Gunther R, Wiezorek T, Wendt TG. [Improved patient repositioning accuracy by integrating an additional jaw fixation into a high precision face mask system in stereotactic radiotherapy of the head]. Strahlenther Onkol. 2003 Aug;179(8):571-5. doi: 10.1007/s00066-003-0941-3. German.
- Kimmel Cancer Center at Thomas Jefferson UniversityLink provided by the sponsor.
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Active, not recruiting
Comparing Single vs Multiple Dose Radiation for Cancer Patients With Brain Metastasis and Receiving Immunotherapy
NSCLC, Renal Cell Carcinoma
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.
Maria Werner-Wasik, MD principal investigator
Thomas Jefferson University
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 GTC frame, Thermoplastic facemask and Stereotactic radiation therapy in people with Patients Receiving Fractionated Stereotactic Radiotherapy and for Brain Tumors, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
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 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 29 Nov 2016. 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 United States. 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?
Yes. Results are posted in the registry (first posted 19 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Distance From Ideal to Center of GTC Frame and BrainLab Thermoplastic Mask With Respect to Average and Variability (time frame: Measurements taken during SRT). 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 NCT00328510, which also lists 3 linked publications.
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 29 Nov 2016.