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
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
- Median time to progression of treated tumor for up to 2 years [ Time Frame: day 1 to 2 years ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
- Cause of death as assessed by medical records and autopsy at time of death [ Time Frame: variable, survival of the patient ] [ Designated as safety issue: No ]
|Study Start Date:||June 2002|
|Estimated Study Completion Date:||November 2016|
|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||Comprehensive Cancer Center of Wake Forest University|