A Phase I/II Dose-Escalation/Efficacy Study of Palliative Extracranial Radiosurgery Using the Elektra Stereotactic Body Frame System
- 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)
- 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.
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose for up to 90 days after completion of study treatment
day 1 through 90
James Urbanic, MD
Comprehensive Cancer Center of Wake Forest University
United States: Institutional Review Board
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|