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

Home

Study Topics

Glossary


	Full Text View


	Tabular View


	Contacts and Locations


	No Study Results Posted


	Related Studies

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. Last updated on November 14, 2008. Information provided by National Cancer Institute (NCI)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Internal Radiation Therapy With or Without Stereotactic Radiosurgery in Treating Patients With Newly Diagnosed Brain Metastases

Official Title ^†

A Phase II Study Utilizing Focal Radiation in Patients With 1-3 Brain Metastases

Brief Summary

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.

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.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Open Label

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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 ]

Condition ^†

Brain and Central Nervous System Tumors

Intervention ^†

Procedure: brachytherapy
Procedure: conventional surgery
Procedure: stereotactic radiosurgery

MEDLINE PMIDs

Links

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

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Start Date ^†

December 2003

Completion Date

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00096252

Organization ID

CDR0000378193

Secondary IDs ^††

CCF-IRB-6675, CCF-CTSRC-1007, PROXIMA-CCF-IRB-6675

Study Sponsor ^†

The Cleveland Clinic

Collaborators ^††

Investigators ^†

Study Chair:

Michael A. Vogelbaum, MD, PhD

The Cleveland Clinic

Information Provided By

National Cancer Institute (NCI)

Verification Date

November 2008

First Received Date ^†

November 9, 2004

Last Updated Date

November 14, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.