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| Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003324 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Brain and Central Nervous System Tumors |
Procedure: conventional surgery Radiation: radiation therapy |
| Study Type: | Interventional |
| Study Design: | Treatment |
| 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 |
| Estimated Enrollment: | 60 |
| Study Start Date: | December 1998 |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, California | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| Study Chair: | Judith M. Ford, MD, PhD | Jonsson Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000066275, UCLA-HSPC-9710074, UCLA-HSPC-971007401, NCI-G98-1417 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003324 History of Changes |
| Health Authority: | United States: Federal Government |
|
adult tumors metastatic to brain |
|
Neoplasm Metastasis Central Nervous System Neoplasms Nervous System Neoplasms |
|
Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes |
Nervous System Diseases Neoplasm Metastasis Central Nervous System Neoplasms Nervous System Neoplasms |