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

Tracking Information

First Received Date ^ICMJE

April 5, 2005

Last Updated Date

December 3, 2009

Start Date ^ICMJE

April 2004

Estimated Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Local control rate as measured by MRI with contrast at 1 year

Change History

Complete list of historical versions of study NCT00107367 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Radiation Therapy in Treating Patients Who Are Undergoing Surgery to Remove a Metastatic Brain Tumor

Official Title ^ICMJE

A Phase I/II Study Utilizing the Zeiss INTRABEAM System for the Treatment of a Resected Solitary Brain Metastasis

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase I
Phase II

Study Design ^ICMJE

Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Metastatic Cancer

Intervention ^ICMJE

Procedure: conventional surgery
Radiation: intraoperative radiation therapy

Study Arms

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00107367

Other Study ID Numbers ^ICMJE

CDR0000378144, CCF-IRB-7003, CCF-510K, CCF-K992577, CCF-CTSRC-1065

Has Data Monitoring Committee

Responsible Party

Robert Weil, Cleveland Clinic Taussig Cancer Center

Study Sponsor ^ICMJE

The Cleveland Clinic

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Robert Weil, MD

The Cleveland Clinic

Information Provided By

National Cancer Institute (NCI)

Verification Date

July 2009

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