Trial Information

A Phase I/II Dose-Escalation/Efficacy Study of Palliative Extracranial Radiosurgery Using the Elektra Stereotactic Body Frame System

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.