Extracranial Stereotactic Radiosurgery in Treating Patients With Solid Tumors
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Registration Number
- NCT00311597
- Lead Sponsor
- Wake Forest University Health Sciences
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Maximum tolerated dose for up to 90 days after completion of study treatment day 1 through 90 Minimum dose required for local control as assessed by RECIST one-dimensional criterion and volumetric analysis for 90 days after completion of study treatment day 1 through 90
- Secondary Outcome Measures
Name Time Method Median time to progression of treated tumor for up to 2 years day 1 to 2 years Toxicity as assessed by NCI Common Toxicity Criteria (CTC) version 2.0 for up to 90 days after completion of study treatment day 1 through 90 Cause of death as assessed by medical records and autopsy at time of death variable, survival of the patient
Trial Locations
- Locations (1)
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States
Wake Forest University Comprehensive Cancer Center🇺🇸Winston-Salem, North Carolina, United States