Stereotactic Radiosurgery and Radiation Therapy in Treating Patients With Glioblastoma Multiforme

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00253448
First received: November 11, 2005
Last updated: August 25, 2011
Last verified: August 2011
  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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Radiation: radiation therapy
Radiation: stereotactic radiosurgery
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Overall Survival After Treatment [ Time Frame: Minimum of 5 years. ] [ Designated as safety issue: No ]
    Followed every 3 months for 2 years, every 6 months for 3 years, and annually thereafter for at least 5 years


Enrollment: 35
Study Start Date: December 2002
Study Completion Date: July 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: radiation therapy
    No more than 2 weeks later, patients undergo conventional radiotherapy once daily, 5 days a week, for 6 weeks.
    Radiation: stereotactic radiosurgery
    stereotactic radiosurgery to high-risk areas of active tumor determined by MR-spectroscopy
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00253448

Locations
United States, Ohio
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Southwest General Health Center
Cleveland, Ohio, United States, 44130
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Douglas Einstein, MD, PhD Kettering Medical Center, Wright State University
  More Information

Additional Information:
No publications provided by Case Comprehensive Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00253448     History of Changes
Other Study ID Numbers: CWRU1302, P30CA043703, CASE-CWRU-1302
Study First Received: November 11, 2005
Results First Received: June 29, 2011
Last Updated: August 25, 2011
Health Authority: United States: Federal Government

Keywords provided by Case Comprehensive Cancer Center:
adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Glioblastoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on August 21, 2014