Pilot Study of Adjuvant Fractionated Stereotactic Radiotherapy Following Surgical Removal of Cerebral Metastases
18 Years
N/A
Both
Metastatic Cancer
Trial Information
Pilot Study of Adjuvant Fractionated Stereotactic Radiotherapy Following Surgical Removal of Cerebral Metastases
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.
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Judith M. Ford, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Jonsson Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000066270
NCT ID:
NCT00003320
Start Date:
March 1997
Completion Date:
Related Keywords:
- Metastatic Cancer
- tumors metastatic to brain
- Neoplasm Metastasis
- Neoplasms
- Neoplasms, Second Primary
Name | Location |
|---|---|
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
