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Radiation Therapy With or Without Surgery in Treating Patients Who Have Brain Metastases

Primary Purpose

Metastatic Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
conventional surgery
radiation therapy
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: Biopsy, CT scan, or MRI proven cerebral metastases with known current or previous systemic malignancy OR Biopsy proven cerebral metastases other than from small cell lung cancer or lymphoma Refused whole brain radiation therapy OR Received prior whole brain radiation therapy and ineligible for other relapse protocols 18 and over Karnofsky 60-100% Life expectancy:At least 3 months Concurrent steroids allowed Exclusion Criteria: more than four cerebral metastases on MRI scan and suitable for focal treatment with surgery and/or stereotactic radiotherapy with a linear accelerator more than 2 weeks since prior focal radiation more than 2 weeks since prior focal surgery

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
NCT00003324
Brief Title
Radiation Therapy With or Without Surgery in Treating Patients Who Have Brain Metastases
Official Title
Prognostic Factors Associated With Successful Omission of Whole Brain Radiotherapy in Patients With 4 or Less Cerebral Metastases Treated With Focal Radiation or Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
December 1997 (undefined)
Primary Completion Date
July 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 in a single high dose. Combining radiation therapy with surgery may be a more effective treatment for brain metastases. PURPOSE: Clinical trial to study the effectiveness of radiation therapy with or without surgery in treating patients who have brain metastases.
Detailed Description
OBJECTIVES: Develop prognostic factors for patients with brain metastases treated by focal treatment without concurrent whole brain irradiation. Determine whether focal treatment without whole brain radiotherapy produces good long-term outcome in patients with four or less cerebral metastases. Assess survival, physical and cognitive functioning, and quality of life of patients treated on this protocol. OUTLINE: Quality of life is assessed using the FACT-BR scale, physical function is assessed using the FIM scale, and cognition is assessed using two brief pencil and paper tests. Patients receive focal therapy for cerebral metastases by any combination of (1) surgery plus fractionated stereotactic radiotherapy to surgical bed, or (2) single fraction stereotactic radiotherapy by linear accelerator with or without a radiation sensitizer. Patients are followed at 2 and 10 weeks, then every 3 months for 18 months, then every 6 months for 3 years, then annually. Quality of life is assessed at each followup visit. Patients suffering intracerebral relapse are offered further focal therapy if they have no more than 3 metastases, no more than 6 lesions over consecutive scans, and continue to have life expectancy of at least 3 months and Karnofsky performance status of 60-100%. Otherwise, relapsed patients are offered whole brain radiotherapy or supportive treatment with steroids, and may also receive stereotactic boost to the new lesions. Patients who have received prior whole brain irradiation will be offered entry into other protocols if eligible or supportive treatment with steroids. Patients are followed as above. PROJECTED ACCRUAL: At least 60 patients will be enrolled in 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
61 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Biopsy, CT scan, or MRI proven cerebral metastases with known current or previous systemic malignancy OR Biopsy proven cerebral metastases other than from small cell lung cancer or lymphoma Refused whole brain radiation therapy OR Received prior whole brain radiation therapy and ineligible for other relapse protocols 18 and over Karnofsky 60-100% Life expectancy:At least 3 months Concurrent steroids allowed Exclusion Criteria: more than four cerebral metastases on MRI scan and suitable for focal treatment with surgery and/or stereotactic radiotherapy with a linear accelerator more than 2 weeks since prior focal radiation more than 2 weeks since prior focal surgery
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

Citations:
PubMed Identifier
12622453
Citation
Chitapanarux I, Goss B, Vongtama R, Frighetto L, De Salles A, Selch M, Duick M, Solberg T, Wallace R, Cabatan-Awang C, Ford J. Prospective study of stereotactic radiosurgery without whole brain radiotherapy in patients with four or less brain metastases: incidence of intracranial progression and salvage radiotherapy. J Neurooncol. 2003 Jan;61(2):143-9. doi: 10.1023/a:1022173922312.
Results Reference
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Radiation Therapy With or Without Surgery in Treating Patients Who Have Brain Metastases

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