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

Metastatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00107367
• Other study ID #: CDR0000378144
• Secondary ID: CCF-IRB-7003CCF-
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: April 5, 2005
• Last updated: January 9, 2014
• Start date: April 2004

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Procedure:
• conventional surgery

Radiation:
• intraoperative radiation therapy

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local control rate as measured by MRI with contrast at 1 year			No