A Phase II Study Utilizing Focal Radiation in Patients With 1-3 Brain Metastases
18 Years
N/A
Both
Metastatic Cancer
Trial Information
A Phase II Study Utilizing Focal Radiation in Patients With 1-3 Brain Metastases
OBJECTIVES:
Primary
- Determine the 6-month and 1-year local control rate in patients with newly diagnosed
supratentorial brain metastases treated with brachytherapy using the intracavity
GliaSite^® Radiation Therapy System (RTS) after surgical resection.
Secondary
- Determine the overall survival of patients treated with this regimen.
- Determine distant brain recurrence in patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Assess the quality of life of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients undergo surgical resection of the metastatic brain lesion(s) followed by
implantation of the GliaSite^® Radiation Therapy System (RTS). Beginning within the 21 days
after surgical resection, patients undergo brachytherapy using the GliaSite^® RTS over 3-7
days. Patients with tumor(s) remaining after surgery also undergo stereotactic radiosurgery
14-42 days after surgical resection and after completion of brachytherapy. Treatment
continues in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, at 1 and 3 months, and then every 3 months for 2
years.
Patients are followed at 1 and 3 months and then every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic carcinoma
- Stable systemic disease staged within the past 6 weeks
- No histology of lymphoma or small cell lung cancer
- Newly diagnosed supratentorial metastatic brain lesions
- One to three lesions with at least 1 dominant lesion that is amenable to
surgical resection as visualized on enhanced MRI
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 70-100%
Life expectancy
- At least 6 months
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Cardiovascular
- No uncontrolled hypertension
- No unstable angina pectoris
- No evidence of uncontrolled cardiac dysrhythmia
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other serious infection or medical illness that would preclude study therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior polifeprosan 20 with carmustine implant (Gliadel^® wafer) for brain
metastasis
- No prior temozolomide for brain metastasis
Endocrine therapy
- Not specified
Radiotherapy
- No concurrent external-beam radiotherapy to the brain
- No concurrent whole-brain radiotherapy
Surgery
- Not specified
Other
- No other prior or concurrent conventional or investigational systemic agents for
brain metastasis
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Six-month local control rate
Safety Issue:
No
Principal Investigator
Michael A. Vogelbaum, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
The Cleveland Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000378193
NCT ID:
NCT00096252
Start Date:
December 2003
Completion Date:
Related Keywords:
- Metastatic Cancer
- tumors metastatic to brain
- Neoplasm Metastasis
- Neoplasms
- Neoplasms, Second Primary
Name | Location |
|---|---|
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
