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| ID | Type | Description | Link |
|---|---|---|---|
| CCCWFU-99502 | |||
| CCCWFU-BG02-187 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a phase I dose-escalation study followed by a phase II open-label study. Patients are stratified according to tumor size.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single fractionated radiation adjusted for tumor size | Experimental | Single fractionated radiation adjusted for volume of tumor tissue encompassed by desired isodose line |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiosurgery | Procedure | single fractionated radiation therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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DISEASE CHARACTERISTICS:
Presence of well-circumscribed tumor on contrast-enhanced CT scan or MRI
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| James Urbanic, MD | Wake Forest University Health Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157-1096 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Stieber VW, Hinson W, Kearns W, et al.: A phase I/II dose-escalation/efficacy study of palliative stereotactic body radiosurgery, including bioanatomic imaging to assess response. [Abstract] Int J Radiat Oncol Biol Phys 60 (1 Suppl 1): A-2381, S563-4, 2004. |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| Cause of death as assessed by medical records and autopsy at time of death | variable, survival of the patient |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |