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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: | NCT00003320 |
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.
Condition | Intervention |
Brain and Central Nervous System Tumors |
Procedure: radiation therapy Procedure: stereotactic radiosurgery Procedure: surgical procedure |
MedlinePlus related topics: | Cancer |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Pilot Study of Adjuvent Fractionated Stereotactic Radiotherapy Following Surgical Removal of Cerebral Metastases |
Estimated Enrollment: | 40 |
Study Start Date: | March 1997 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: 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)
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Pulmonary: No severe asthma requiring therapy Other: No allergy to iodine or contrast media Not pregnant
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No concurrent chemotherapy Endocrine therapy: Prior or concurrent required steroids allowed Radiotherapy: No prior whole brain irradiation or focal irradiation to current sites of disease Prior stereotactic radiotherapy of cerebral metastases allowed provided no prior irradiation of current surgical sites Surgery: Prior surgery of cerebral metastases allowed
United States, California | |||||
Jonsson Comprehensive Cancer Center, UCLA | |||||
Los Angeles, California, United States, 90095-1781 |
Jonsson Comprehensive Cancer Center |
National Cancer Institute (NCI) |
Study Chair: | Judith M. Ford, MD, PhD | Jonsson Comprehensive Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000066270, UCLA-HSPC-970101503, UCLA-HSPC-970101502, NCI-G98-1416 |
First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003320 |
Health Authority: | United States: Federal Government |
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