Clinical trial NCT00253448: Stereotactic Radiosurgery and Radiation Therapy in Treating Patients With Glioblastoma Multiforme
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Brain and Central Nervous System Tumors
Keywords: adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-11-15
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Overall Survival After Treatment
timeFrame: Minimum of 5 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Southwest General Health Center
state: Ohio
Study officials:
affiliation: Kettering Medical Center, Wright State University
name: Douglas Einstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.