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Radiation Therapy Following Surgery to Remove Brain Metastases

Primary Purpose

Metastatic Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
surgical procedure
radiation therapy
stereotactic radiosurgery
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Cancer focused on measuring tumors metastatic to brain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jonsson Comprehensive Cancer Center, UCLA

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
July 30, 2020
Sponsor
Jonsson Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00003320
Brief Title
Radiation Therapy Following Surgery to Remove Brain Metastases
Official Title
Pilot Study of Adjuvant Fractionated Stereotactic Radiotherapy Following Surgical Removal of Cerebral Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
March 1997 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer
Keywords
tumors metastatic to brain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
surgical procedure
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Intervention Type
Radiation
Intervention Name(s)
stereotactic radiosurgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith M. Ford, MD, PhD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Radiation Therapy Following Surgery to Remove Brain Metastases

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