Radiation Therapy in Treating Patients Who Are Undergoing Surgery to Remove a Metastatic Brain Tumor - Full Text View

Sponsor:	The Cleveland Clinic
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00107367

Purpose

RATIONALE: Specialized radiation therapy that delivers radiation directly to the area where a tumor was surgically removed may kill any remaining tumor cells and cause less damage to normal tissue.

PURPOSE: This phase I/II trial is studying radiation therapy to see how well it works in treating patients who are undergoing surgery to remove a metastatic brain tumor.

Condition	Intervention	Phase
Metastatic Cancer	Procedure: conventional surgery Radiation: intraoperative radiation therapy	Phase I Phase II

Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase I/II Study Utilizing the Zeiss INTRABEAM System for the Treatment of a Resected Solitary Brain Metastasis

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer

U.S. FDA Resources

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

Primary Outcome Measures:

Local control rate as measured by MRI with contrast at 1 year [ Designated as safety issue: No ]

Estimated Enrollment:	62
Study Start Date:	April 2004
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Determine the 1-year local control rate in patients undergoing resection of a solitary brain metastasis comprising intraoperative radiotherapy using the INTRABEAM® system.

Secondary

Determine the survival of patients treated with this therapy.
Determine distant recurrence of disease in patients treated with this therapy.
Determine the toxicity of this therapy in these patients.
Determine the quality of life of patients treated with this therapy.

OUTLINE: This is a nonrandomized study.

Patients undergo surgical resection of a brain metastasis. Patients then undergo intraoperative radiotherapy using the INTRABEAM® system.

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

Patients are followed within 48 hours after surgery, at 1 and 3 months, and then every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 31-62 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:

Newly diagnosed supratentorial solitary brain metastasis by enhanced MRI or CT scan
- Resectable disease
- Histological evidence of metastatic carcinoma by intraoperative pathology
No primary lymphoma, germ cell carcinoma, or small cell lung cancer

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Karnofsky 70-100%

Life expectancy

At least 3 months

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Cardiovascular

No uncontrolled hypertension
No unstable angina pectoris
No uncontrolled dysrhythmias

Other

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

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

Endocrine therapy

Not specified

Radiotherapy

No prior brain radiotherapy of any kind, including local or whole brain external beam radiotherapy, brachytherapy, or stereotactic radiosurgery
No concurrent external beam radiotherapy to the brain
Not planning adjuvant whole brain radiotherapy after study therapy

Surgery

Not specified

Other

No other prior conventional or investigational local or systemic agents for brain metastasis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00107367

Locations

United States, Ohio
Cleveland Clinic Taussig Cancer Center	Recruiting
Cleveland, Ohio, United States, 44195
Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente 866-223-8100

Sponsors and Collaborators

The Cleveland Clinic

Investigators

Study Chair:

Robert Weil, MD

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 ( Robert Weil )
ClinicalTrials.gov Identifier:	NCT00107367 History of Changes
Other Study ID Numbers:	CDR0000378144, CCF-IRB-7003, CCF-510K, CCF-K992577, CCF-CTSRC-1065
Study First Received:	April 5, 2005
Last Updated:	December 3, 2009
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

tumors metastatic to brain

Additional relevant MeSH terms:

Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes

ClinicalTrials.gov processed this record on September 01, 2010