Internal Radiation Therapy With or Without Stereotactic Radiosurgery in Treating Patients With Newly Diagnosed Brain Metastases - Full Text View

Sponsor:	The Cleveland Clinic
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00096252

Purpose

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.

Condition	Intervention	Phase
Metastatic Cancer	Procedure: conventional surgery Radiation: brachytherapy Radiation: stereotactic radiosurgery	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Study Utilizing Focal Radiation in Patients With 1-3 Brain Metastases

Resource links provided by NLM:

MedlinePlus related topics: Cancer Surgery

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Six-month local control rate [ Designated as safety issue: No ]
One-year local control rate [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	50
Study Start Date:	December 2003
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00096252

Locations

United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

The Cleveland Clinic

Investigators

Study Chair:

Michael A. Vogelbaum, MD, PhD

The Cleveland Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Cleveland Clinic Taussig Cancer Center ( Michael A. Vogelbaum )
Study ID Numbers:	CDR0000378193, CCF-IRB-6675, CCF-CTSRC-1007, PROXIMA-CCF-IRB-6675
Study First Received:	November 9, 2004
Last Updated:	August 29, 2009
ClinicalTrials.gov Identifier:	NCT00096252 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

tumors metastatic to brain

Additional relevant MeSH terms:

Neoplasms
Neoplastic Processes
Pathologic Processes
Neoplasm Metastasis

ClinicalTrials.gov processed this record on November 27, 2009