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Internal Radiation Therapy With or Without Stereotactic Radiosurgery in Treating Patients With Newly Diagnosed Brain Metastases
This study is ongoing, but not recruiting participants.
Study NCT00096252   Information provided by National Cancer Institute (NCI)
First Received: November 9, 2004   Last Updated: August 29, 2009   History of Changes

November 9, 2004
August 29, 2009
December 2003
October 2008   (final data collection date for primary outcome measure)
  • Six-month local control rate [ Designated as safety issue: No ]
  • One-year local control rate [ Designated as safety issue: No ]
  • Six-month local control rate
  • One-year local control rate
Complete list of historical versions of study NCT00096252 on ClinicalTrials.gov Archive Site
  • Overall survival [ Designated as safety issue: No ]
  • Distant brain recurrence [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Quality of life [ Designated as safety issue: No ]
  • Overall survival
  • Distant brain recurrence
  • Toxicity
  • Quality of life
 
Internal Radiation Therapy With or Without Stereotactic Radiosurgery in Treating Patients With Newly Diagnosed Brain Metastases
A Phase II Study Utilizing Focal Radiation in Patients With 1-3 Brain Metastases

RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Stereotactic radiosurgery may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. Giving internal radiation therapy after surgery with or without radiosurgery may kill any remaining tumor cells.

PURPOSE: This phase II trial is studying how well internal radiation therapy with or without stereotactic radiosurgery works in treating patients who have undergone surgery for newly diagnosed brain metastases.

OBJECTIVES:

Primary

  • Determine the 6-month and 1-year local control rate in patients with newly diagnosed supratentorial brain metastases treated with brachytherapy using the intracavity GliaSite^® Radiation Therapy System (RTS) after surgical resection.

Secondary

  • Determine the overall survival of patients treated with this regimen.
  • Determine distant brain recurrence in patients treated with this regimen.
  • Determine the toxic effects of this regimen in these patients.
  • Assess the quality of life of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients undergo surgical resection of the metastatic brain lesion(s) followed by implantation of the GliaSite^® Radiation Therapy System (RTS). Beginning within the 21 days after surgical resection, patients undergo brachytherapy using the GliaSite^® RTS over 3-7 days. Patients with tumor(s) remaining after surgery also undergo stereotactic radiosurgery 14-42 days after surgical resection and after completion of brachytherapy. Treatment continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at 1 and 3 months, and then every 3 months for 2 years.

Patients are followed at 1 and 3 months and then every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Phase II
Interventional
Treatment, Open Label
Metastatic Cancer
  • Procedure: conventional surgery
  • Radiation: brachytherapy
  • Radiation: stereotactic radiosurgery
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
50
 
October 2008   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed metastatic carcinoma

    • Stable systemic disease staged within the past 6 weeks
    • No histology of lymphoma or small cell lung cancer
  • Newly diagnosed supratentorial metastatic brain lesions

    • One to three lesions with at least 1 dominant lesion that is amenable to surgical resection as visualized on enhanced MRI

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 70-100%

Life expectancy

  • At least 6 months

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Cardiovascular

  • No uncontrolled hypertension
  • No unstable angina pectoris
  • No evidence of uncontrolled cardiac dysrhythmia

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other serious infection or medical illness that would preclude study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior polifeprosan 20 with carmustine implant (Gliadel^® wafer) for brain metastasis
  • No prior temozolomide for brain metastasis

Endocrine therapy

  • Not specified

Radiotherapy

  • No concurrent external-beam radiotherapy to the brain
  • No concurrent whole-brain radiotherapy

Surgery

  • Not specified

Other

  • No other prior or concurrent conventional or investigational systemic agents for brain metastasis
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00096252
Michael A. Vogelbaum, Cleveland Clinic Taussig Cancer Center
CDR0000378193, CCF-IRB-6675, CCF-CTSRC-1007, PROXIMA-CCF-IRB-6675
The Cleveland Clinic
 
Study Chair: Michael A. Vogelbaum, MD, PhD The Cleveland Clinic
National Cancer Institute (NCI)
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP