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

NCT ID: NCT00107367

Last Updated: 2014-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30

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.

Conditions

Metastatic Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

conventional surgery

Intervention Type: PROCEDURE

intraoperative radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Cleveland Clinic Taussig Cancer Center

Principal Investigators

Robert Weil, MD

Role: STUDY_CHAIR

The Cleveland Clinic

Locations

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente

Role: primary

866-223-8100

References

Weil RJ, Mavinkurve GG, Chao ST, Vogelbaum MA, Suh JH, Kolar M, Toms SA. Intraoperative radiotherapy to treat newly diagnosed solitary brain metastasis: initial experience and long-term outcomes. J Neurosurg. 2015 Apr;122(4):825-32. doi: 10.3171/2014.11.JNS1449. Epub 2015 Jan 23.

Reference Type: DERIVED

PMID: 25614945 (View on PubMed)

Other Identifiers

CCF-IRB-7003

Identifier Type: -

Identifier Source: secondary_id

CCF-510K

Identifier Type: -

Identifier Source: secondary_id

CCF-K992577

Identifier Type: -

Identifier Source: secondary_id

CCF-CTSRC-1065

Identifier Type: -

Identifier Source: secondary_id

CDR0000378144

Identifier Type: -

Identifier Source: org_study_id