Extracranial Stereotactic Radiosurgery in Treating Patients With Solid Tumors
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.
|Unspecified Adult Solid Tumor, Protocol Specific||Procedure: Radiosurgery||Phase 1 Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase I/II Dose-Escalation/Efficacy Study of Palliative Extracranial Radiosurgery Using the Elektra Stereotactic Body Frame System|
- Maximum tolerated dose for up to 90 days after completion of study treatment [ Time Frame: 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 [ Time Frame: day 1 through 90 ]
- Median time to progression of treated tumor for up to 2 years [ Time Frame: 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 [ Time Frame: day 1 through 90 ]
- Cause of death as assessed by medical records and autopsy at time of death [ Time Frame: variable, survival of the patient ]
|Actual Study Start Date:||June 2002|
|Study Completion Date:||March 2009|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
Experimental: Single fractionated radiation adjusted for tumor size
Single fractionated radiation adjusted for volume of tumor tissue encompassed by desired isodose line
single fractionated radiation therapy
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00311597
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|Study Chair:||James Urbanic, MD||Wake Forest University Health Sciences|