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Stereotactic Radiosurgery and Radiation Therapy in Treating Patients With Glioblastoma Multiforme

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT00253448
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Case Comprehensive Cancer Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Douglas Einstein, MD, PhD
Principal Investigator Affiliation	Kettering Medical Center, Wright State University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Completed
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain and Central Nervous System Tumors

Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cleveland, Ohio

Status

Address

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065

Southwest General Health Center, Cleveland, Ohio