NCT00253448

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2002

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 11, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 15, 2005

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
25 days until next milestone

Results Posted

Study results publicly available

July 26, 2011

Completed
Last Updated

August 29, 2011

Status Verified

August 1, 2011

Enrollment Period

7 years

First QC Date

November 11, 2005

Results QC Date

June 29, 2011

Last Update Submit

August 25, 2011

Conditions

Brain and Central Nervous System Tumors

Keywords

adult glioblastomaadult giant cell glioblastomaadult gliosarcoma

Outcome Measures

Primary Outcomes (1)

  • 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.

Interventions

radiation therapyRADIATION

No more than 2 weeks later, patients undergo conventional radiotherapy once daily, 5 days a week, for 6 weeks.

stereotactic radiosurgeryRADIATION

stereotactic radiosurgery to high-risk areas of active tumor determined by MR-spectroscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

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

Cleveland, Ohio, 44106-5065, United States

Location

Southwest General Health Center

Cleveland, Ohio, 44130, United States

Location

Related Publications (1)

  • 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.

    PMID: 22445005DERIVED

MeSH Terms

Conditions

Central Nervous System NeoplasmsGlioblastomaGliosarcoma

Interventions

RadiotherapyRadiosurgery

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesAstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

TherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Results Point of Contact

Title
Research Investigator
Organization
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
douglas.einstein@khnetwork.org
937-395-8646

Study Officials

  • Douglas Einstein, MD, PhD

    Kettering Medical Center, Wright State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2005

First Posted

November 15, 2005

Study Start

December 1, 2002

Primary Completion

December 1, 2009

Study Completion

July 1, 2011

Last Updated

August 29, 2011

Results First Posted

July 26, 2011

Record last verified: 2011-08

Locations

US(2)