Radiation Therapy Following Surgery to Remove Brain Metastases

Metastatic Cancer Clinical Trial

Official title:

Pilot Study of Adjuvant Fractionated Stereotactic Radiotherapy Following Surgical Removal of Cerebral Metastases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003320
• Other study ID #: CDR0000066270
• Secondary ID: UCLA-HSPC-970101
• Status: Completed
• Phase: N/A
• Start date: March 1997

Study information

• Verified date: July 2012
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Procedure:
• surgical procedure

Radiation:
• radiation therapy

• stereotactic radiosurgery

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States,