Radiation Therapy Following Surgery to Remove Brain Metastases

NCT ID: NCT00003320

Last Updated: 2020-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-03-31

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy after surgery to remove brain metastases may decrease the amount of radiation required to treat brain metastases.

PURPOSE: Pilot trial to study the effectiveness of radiation therapy following surgery to remove brain metastases.

Detailed Description

OBJECTIVES: I. Assess the safety and tolerability of focal stereotactic radiotherapy to the surgical bed following excision of cerebral metastases, as an alternative to whole brain irradiation. II. Measure the local relapse rate at the surgical site after surgery and stereotactic radiotherapy in patients with cerebral metastases. III. Measure the regional relapse rate, in the brain but away from the treated site, following treatment in these patients.

OUTLINE: All patients undergo surgical removal of their cerebral metastases followed by adjuvant fractionated stereotactic radiotherapy daily for 5 days. Patients are given up to 5 weeks following surgery to recover and reach the required performance status. Radiotherapy must commence within 6 weeks of surgery. Patients are followed at 2 weeks after treatment, monthly for 6 months, every 3 months for the next 18 months, every 6 months for the next year, and then annually for years 3-5.

PROJECTED ACCRUAL: There will be 20-40 patients accrued into this study.

Conditions

Metastatic Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

surgical procedure

Intervention Type: PROCEDURE

radiation therapy

Intervention Type: RADIATION

stereotactic radiosurgery

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed cerebral metastases post surgical resection
• No greater than 3 cerebral metastases postresection
• Gross resection at operation as documented in operation note and postoperative MRI Patients must have current surgical sites that have not been previously irradiated
• No other indication for whole brain irradiation (i.e., multiple untreated metastases not suitable for single fraction stereotactic radiotherapy, leptomeningeal disease)
• Age: 18 and over
• Karnofsky 60-100%
• Life expectancy: At least 3 months
• Prior or concurrent required steroids allowed
• Prior stereotactic radiotherapy of cerebral metastases allowed provided no prior irradiation of current surgical sites
• Prior surgery of cerebral metastases allowed

Exclusion Criteria

• severe asthma requiring therapy
• allergy to iodine or contrast media
• pregnant
• concurrent chemotherapy
• prior whole brain irradiation or focal irradiation to current sites of disease

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

Sponsors

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Judith M. Ford, MD, PhD

Role: STUDY_CHAIR

Jonsson Comprehensive Cancer Center

Locations

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, United States

Countries

United States

Other Identifiers

UCLA-HSPC-970101503

Identifier Type: -

Identifier Source: secondary_id

UCLA-HSPC-970101502

Identifier Type: -

Identifier Source: secondary_id

NCI-G98-1416

Identifier Type: -

Identifier Source: secondary_id

CDR0000066270

Identifier Type: -

Identifier Source: org_study_id