Brain and Central Nervous System TumorsPhase 2NCT00253448
Stereotactic Radiosurgery and Radiation Therapy in Treating Patients With Glioblastoma Multiforme
A Phase 2 study testing radiation therapy and stereotactic radiosurgery in people with Brain and Central Nervous System Tumors, run by Case Comprehensive Cancer Center at 2 sites in United States.
Trial summary
RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving stereotactic radiosurgery together with radiation therapy may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- radiation therapy and stereotactic radiosurgery
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2002to Jul 2011
- Phase
- Phase 2
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed grade IV malignant glioblastoma multiforme
- Diagnosis by surgical biopsy or resection within the past 5 weeks
- Post-operative diagnostic contrast-enhanced MRI scan with MR spectroscopy must be performed prior to initiating study treatment
- High-risk area of active tumor without margin by MR spectroscopy
- Meets the following criteria for radiosurgery:
- Maximum diameter ≤ 40 mm
- Located > 5 mm from the optic nerve or chiasm
- Does not involve the brainstem
- No multifocal or recurrent malignant glioma
PATIENT CHARACTERISTICS:
Performance status
- Karnofsky 50-100%
Life expectancy
- At least 3 months
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Not pregnant
- Negative pregnancy test
PRIOR CONCURRENT THERAPY:
Chemotherapy
- At least 6 weeks since chemotherapy
- Concurrent chemotherapy allowed
Endocrine therapy
- Concurrent steroids allowed, but at the smallest therapeutic dose possible
Radiotherapy
- No prior in-field radiotherapy to the head and neck
Surgery
- See Disease Characteristics
- Recovered from prior surgery or any post-operative complication
Other
- Concurrent antiseizure medications allowed
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
Southwest General Health Center
Cleveland, Ohio, 44130
About this study
Official title: Phase II Trial of Conventional Radiotherapy With Stereotactic Radiosurgery to High Risk Tumor Regions as Determined by Functional Imaging in Patients With Glioblastoma Multiforme
RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving stereotactic radiosurgery together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving stereotactic radiosurgery together with radiation therapy works in treating patients with glioblastoma multiforme.
Read the detailed description
OBJECTIVES:
Primary
- Determine the feasibility and efficacy of stereotactic radiosurgery to high-risk tumor regions and conventional radiotherapy in patients with glioblastoma multiforme.
- Determine overall survival of patients treated with this regimen.
Secondary
- Determine 6-month progression-free survival of patients treated with this regimen.
- Determine the absence of tumor growth and/or activity on conventional MR/MR spectroscopy imaging in patients treated with this regimen.
- Determine the frequency and severity of RTOG (Radiation Therapy Oncology Group) CNS toxic effects in patients treated with this regimen.
- Determine the neurologic function and quality of life of patients treated with this regimen.
OUTLINE: This is a pilot study.
Patients undergo stereotactic radiosurgery to high-risk areas of active tumor determined by MR-spectroscopy. No more than 2 weeks later, patients undergo conventional radiotherapy once daily, 5 days a week, for 6 weeks.
Quality of life is assessed at baseline, weekly during radiotherapy, at 1 and 3 months after completion of radiotherapy, and then every 3 months for 2 years, every 6 months for 3 years, and annually thereafter.
After completion of study treatment, patients are followed periodically for at least 5 years.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- radiation therapy, stereotactic radiosurgery
- Keywords
- adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma
- Medical subject headings
- Central Nervous System Neoplasms, Glioblastoma, Gliosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiation therapyRadiation
No more than 2 weeks later, patients undergo conventional radiotherapy once daily, 5 days a week, for 6 weeks.
stereotactic radiosurgeryRadiation
stereotactic radiosurgery to high-risk areas of active tumor determined by MR-spectroscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival After Treatment
Followed every 3 months for 2 years, every 6 months for 3 years, and annually thereafter for at least 5 years
Measured: Minimum of 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startDec 2002
- Primary completionDec 2009
- Study completionJul 2011
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 (1)Papers the sponsor has linked to this study.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Douglas Einstein, MD, PhD, Principal investigator, Kettering Medical Center, Wright State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00253448
- Sponsor's protocol ID
- CWRU1302
- Other IDs
- P30CA043703, CASE-CWRU-1302
- Status last verified
- Aug 2011
- First submitted
- 11 Nov 2005
- Last updated
- 29 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Einstein DB, Wessels B, Bangert B, Fu P, Nelson AD, Cohen M, Sagar S, Lewin J, Sloan A, Zheng Y, Williams J, Colussi V, Vinkler R, Maciunas R. Phase II trial of radiosurgery to magnetic resonance spectroscopy-defined high-risk tumor volumes in patients with glioblastoma multiforme. Int J Radiat Oncol Biol Phys. 2012 Nov 1;84(3):668-74. doi: 10.1016/j.ijrobp.2012.01.020. Epub 2012 Mar 22.
PubMed 22445005
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Conventional Radiotherapy With Stereotactic Radiosurgery to High Risk Tumor Regions as Determined by Functional Imaging in Patients With Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT00253448
- Acronym / sponsor ID
- CWRU1302
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2002
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 15 Nov 2005 (estimated)
- Results
- Posted 26 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving stereotactic radiosurgery together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving stereotactic radiosurgery together with radiation therapy works in treating patients with glioblastoma multiforme.
Detailed description
OBJECTIVES:
Primary
- Determine the feasibility and efficacy of stereotactic radiosurgery to high-risk tumor regions and conventional radiotherapy in patients with glioblastoma multiforme.
- Determine overall survival of patients treated with this regimen.
Secondary
- Determine 6-month progression-free survival of patients treated with this regimen.
- Determine the absence of tumor growth and/or activity on conventional MR/MR spectroscopy imaging in patients treated with this regimen.
- Determine the frequency and severity of RTOG (Radiation Therapy Oncology Group) CNS toxic effects in patients treated with this regimen.
- Determine the neurologic function and quality of life of patients treated with this regimen.
OUTLINE: This is a pilot study.
Patients undergo stereotactic radiosurgery to high-risk areas of active tumor determined by MR-spectroscopy. No more than 2 weeks later, patients undergo conventional radiotherapy once daily, 5 days a week, for 6 weeks.
Quality of life is assessed at baseline, weekly during radiotherapy, at 1 and 3 months after completion of radiotherapy, and then every 3 months for 2 years, every 6 months for 3 years, and annually thereafter.
After completion of study treatment, patients are followed periodically for at least 5 years.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| radiation therapyNo more than 2 weeks later, patients undergo conventional radiotherapy once daily, 5 days a week, for 6 weeks. | Radiation | – |
| stereotactic radiosurgerystereotactic radiosurgery to high-risk areas of active tumor determined by MR-spectroscopy | Radiation | – |
Primary outcome
Overall Survival After Treatment
Time frame: Minimum of 5 years.
Followed every 3 months for 2 years, every 6 months for 3 years, and annually thereafter for at least 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22445005Einstein DB, Wessels B, Bangert B, Fu P, Nelson AD, Cohen M, Sagar S, Lewin J, Sloan A, Zheng Y, Williams J, Colussi V, Vinkler R, Maciunas R. Phase II trial of radiosurgery to magnetic resonance spectroscopy-defined high-risk tumor volumes in patients with glioblastoma multiforme. Int J Radiat Oncol Biol Phys. 2012 Nov 1;84(3):668-74. doi: 10.1016/j.ijrobp.2012.01.020. Epub 2012 Mar 22.
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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.
Douglas Einstein, MD, PhD principal investigator
Kettering Medical Center, Wright State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing radiation therapy and stereotactic radiosurgery in people with Brain and Central Nervous System Tumors, run by Case Comprehensive Cancer Center at 2 sites 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?
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 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 26 Jul 2011). 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?
Overall Survival After Treatment (time frame: Minimum of 5 years.). 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 NCT00253448, 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 29 Aug 2011.