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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA043703 | U.S. NIH Grant/Contract | View source | |
| CASE-CWRU-1302 | Other Identifier | Case Comprehensive Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radiation therapy | Radiation | No more than 2 weeks later, patients undergo conventional radiotherapy once daily, 5 days a week, for 6 weeks. | ||
| stereotactic radiosurgery | Radiation | stereotactic radiosurgery to high-risk areas of active tumor determined by MR-spectroscopy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Minimum of 5 years. |
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DISEASE CHARACTERISTICS:
Histologically confirmed grade IV malignant glioblastoma multiforme
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:
No multifocal or recurrent malignant glioma
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Douglas Einstein, MD, PhD | Kettering Medical Center, Wright State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22445005 | Derived | 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. |
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One patient was not eligible for unknown reason
Subjects recruited from 12/31/2002 to 5/8/2008 from medical clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Stereotactic Radiosurgery Plus Conventional Radiotherapy | Single 15-24 Gy Gamma Knife radiosurgical treatment to MR-Spectroscopy active region followed by 60 Gy of conventionally fractionated radiotherapy (2.0 Gy will be given daily 5 days per week for a total of 60.0 Gy) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stereotactic Radiosurgery Plus Conventional Radiotherapy | Single 15-24 Gy Gamma Knife radiosurgical treatment to MR-Spectroscopy active region followed by 60 Gy of conventionally fractionated radiotherapy (2.0 Gy will be given daily 5 days per week for a total of 60.0 Gy) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Median | 95% Confidence Interval | months | Minimum of 5 years. |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stereotactic Radiosurgery Plus Conventional Radiotherapy | Single 15-24 Gy Gamma Knife radiosurgical treatment to MR-Spectroscopy active region followed by 60 Gy of conventionally fractionated radiotherapy (2.0 Gy will be given daily 5 days per week for a total of 60.0 Gy) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CVA | Nervous system disorders | Non-systematic Assessment | Cerebrovascular Accident in a patient taking anticoagulant warfarin |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Investigator | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | 937-395-8646 | douglas.einstein@khnetwork.org |
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| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D005909 | Glioblastoma |
| D018316 | Gliosarcoma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Southwest General Health Center | Cleveland | Ohio | 44130 | United States |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 4 |
| 35 |
| 0 |
| 35 |
|
| Re-operation for radiation necrosis | Nervous system disorders | Non-systematic Assessment | Re-operation for neurological symptom progression secondary to radiation necrosis |
|
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| D001254 |
| Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D008919 | Investigative Techniques |