Extracranial Stereotactic Radiosurgery in Treating Patients With Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00311597|
Recruitment Status : Completed
First Posted : April 6, 2006
Last Update Posted : March 14, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Procedure: Radiosurgery||Phase 1 Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Dose-Escalation/Efficacy Study of Palliative Extracranial Radiosurgery Using the Elektra Stereotactic Body Frame System|
|Actual Study Start Date :||June 2002|
|Actual Primary Completion Date :||September 2007|
|Actual Study Completion Date :||March 2009|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|