Stereotactic Radiosurgery and Radiation Therapy in Treating Patients With Glioblastoma Multiforme

Brain and Central Nervous System Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00253448
• Other study ID #: CWRU1302
• Secondary ID: P30CA043703CASE-
• Status: Completed
• Phase: Phase 2
• First received: November 11, 2005
• Last updated: August 25, 2011
• Start date: December 2002
• Est. completion date: July 2011

Study information

• Verified date: August 2011
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: July 2011
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Glioblastoma
• Nervous System Neoplasms

Intervention

Radiation:
• radiation therapy
No more than 2 weeks later, patients undergo conventional radiotherapy once daily, 5 days a week, for 6 weeks.
• stereotactic radiosurgery
stereotactic radiosurgery to high-risk areas of active tumor determined by MR-spectroscopy

Locations

Country	Name	City	State
United States	Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio
United States	Southwest General Health Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Minimum of 5 years.	No