Spots Global Cancer Trial Database for Extracranial Stereotactic Radiosurgery in Treating Patients With Solid Tumors

Study Description

Brief Summary: 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.

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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