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CyberKnife for Unresectable Renal Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00807339
First Posted: December 11, 2008
Last Update Posted: March 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Irving Kaplan, Beth Israel Deaconess Medical Center
December 10, 2008
December 11, 2008
March 21, 2017
March 2006
January 1, 2014   (Final data collection date for primary outcome measure)
To determine the maximum tolerated dose of CyberKnife radiation [ Time Frame: 2 years ]
Same as current
Complete list of historical versions of study NCT00807339 on ClinicalTrials.gov Archive Site
To evaluate local control, overall survival and late toxicity including preservation of renal function [ Time Frame: 2 years ]
Same as current
Not Provided
Not Provided
 
CyberKnife for Unresectable Renal Tumors
CyberKnife Stereotactic Radiation for Unresectable Renal Tumors/PhaseI Study
This is a dose escalation study using the CyberKnife radiotherapy device for small surgical or medically untreatable renal tumors. Patients with renal tumors 5cms or less in diameter will be accrued onto this study. The ability of CyberKnife to ablate these renal tumors and maintain renal function with dose escalation will be assessed.
The CyberKnife Robotic Radiosurgery System is a unique radiosurgical system capable of treating tumors anywhere in the body noninvasively and with sub-millimeter accuracy. The CyberKnife System delivers radiation using a precise targeting methodology allowing a focal treatment margin around the target, thus limiting the volume of adjacent tissue receiving high doses radiation. This in turn allows the delivery of high doses of radiation to the prostate over a short series of treatments.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Renal Cancer
  • Radiation: Stereotactic radiation
    Dose escalation three consecutive treatments
  • Device: CyberKnife Robotic Radiosurgery System
Experimental: 1
Phase I dose escalation
Interventions:
  • Radiation: Stereotactic radiation
  • Device: CyberKnife Robotic Radiosurgery System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
August 20, 2014
January 1, 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Tumor size 5 cm or less
  • Radiographic evidence of malignancy or Histologically verified primary renal malignancy.
  • If the kidney biopsy is inconclusive but the radiologist determines that the tumor based on the CT/MRI is highly suspicious for cancer, you may participate
  • Patients with highly suspicious lesions on CT or MRI
  • One -three gold fiducials placed in or around tumor
  • Contradiction or patient refusal to partial or complete nephrectomy
  • Age 18 or greater
  • KPS score 70 or greater

Exclusion Criteria:

  • Irreversible coagulopathies that preclude fiducial placement
Sexes Eligible for Study: All
18 Years to 95 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00807339
2005P00384
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Irving Kaplan, Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
Not Provided
Not Provided
Beth Israel Deaconess Medical Center
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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