RATIONALE: Extracranial stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This phase I/II trial is studying the side effects and best dose of extracranial stereotactic radiosurgery and to see how well it works in treating patients with solid tumors.
Primary Outcome Measures:
- Maximum tolerated dose for up to 90 days after completion of study treatment [ Designated as safety issue: Yes ]
- Minimum dose required for local control as assessed by RECIST one-dimensional criterion and volumetric analysis for 90 days after completion of study
treatment [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Radiographic response rate as assessed by RECIST one-dimensional criterion and volumetric analysis for up to 2 years [ Designated as safety issue: No ]
- Median time to progression of treated tumor for up to 2 years [ Designated as safety issue: No ]
- Toxicity as assessed by NCI Common Toxicity Criteria (CTC) version 2.0 for up to 90 days after completion of study treatment [ Designated as safety issue: Yes ]
- Cause of death as assessed by medical records and autopsy at time of death [ Designated as safety issue: No ]
| Estimated Enrollment: |
48 |
| Study Start Date: |
June 2002 |
OBJECTIVES:
Primary
- Establish the maximum tolerated dose (MTD) of extracranial stereotactic radiosurgery in patients with isolated tumors. (Phase I)
- Determine the minimum dose required for local control. (Phase II)
Secondary
- Determine the radiographic response rate.
- Determine the median time to progression of the treated tumor.
- Evaluate the toxicity of treatment.
- Evaluate the cause of death.
OUTLINE: This is a phase I dose-escalation study followed by a phase II open-label study. Patients are stratified according to tumor size.
- Phase I: Patients undergo stereotactic radiosurgery to one lesion. Cohorts of 3-6 patients undergo escalating doses of stereotactic radiosurgery until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 33% of patients experience dose-limiting toxicity within 3 months of treatment.
- Phase II: Patients undergo stereotactic radiosurgery to one lesion at the MTD or at the dose at which local control at 3 months is ≥ 80%, as determined in phase I. After completion of study treatment, patients are followed at 1 month, 3 months, and then every 3 months thereafter.
PROJECTED ACCRUAL: At least 48 patients will be accrued for this study.
Purpose
