Brain and Central Nervous System Tumors
Conditions
Keywords
adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma
Brief 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. 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.
Interventions
RADIATIONradiation therapy
No more than 2 weeks later, patients undergo conventional radiotherapy once daily, 5 days a week, for 6 weeks.
RADIATIONstereotactic radiosurgery
stereotactic radiosurgery to high-risk areas of active tumor determined by MR-spectroscopy
Sponsors
National Cancer Institute (NCI)
Case Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival After Treatment | 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 |
Countries
United States
Participant flow
Recruitment details
Subjects recruited from 12/31/2002 to 5/8/2008 from medical clinic
Pre-assignment details
One patient was not eligible for unknown reason
Participants by arm
| Arm | Count |
|---|---|
| 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) | 35 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Stereotactic Radiosurgery Plus Conventional Radiotherapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 15 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age Continuous | 60.9 years STANDARD_DEVIATION 12.5 |
| Region of Enrollment United States | 35 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 35 |
| serious Total, serious adverse events | 4 / 35 |
Outcome results
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
Time frame: Minimum of 5 years.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Stereotactic Radiosurgery Plus Conventional Radiotherapy | Overall Survival After Treatment | Entire Cohort | 15.8 months |
| Stereotactic Radiosurgery Plus Conventional Radiotherapy | Overall Survival After Treatment | RTOG Glioma Recursive Partitioning Class 3 n=4 | 22 months |
| Stereotactic Radiosurgery Plus Conventional Radiotherapy | Overall Survival After Treatment | RTOG Glioma Recursive Partitioning Class 4 n=13 | 18.7 months |
| Stereotactic Radiosurgery Plus Conventional Radiotherapy | Overall Survival After Treatment | RTOG Glioma Recursive Partitioning Class 5 n=16 | 12.5 months |
| Stereotactic Radiosurgery Plus Conventional Radiotherapy | Overall Survival After Treatment | RTOG Glioma Recursive Partitioning Class 6 n=2 | 3.9 months |
| Stereotactic Radiosurgery Plus Conventional Radiotherapy | Overall Survival After Treatment | Patients receiving concurrent chemotherapy | 20.8 months |
| Stereotactic Radiosurgery Plus Conventional Radiotherapy | Overall Survival After Treatment | Patients who were not candidates for chemotherapy | 11 months |