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CyberKnife for Unresectable Renal Tumors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Beth Israel Deaconess Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00807339
First received: December 10, 2008
Last updated: April 7, 2011
Last verified: April 2011

December 10, 2008
April 7, 2011
March 2006
October 2011   (final data collection date for primary outcome measure)
To determine the maximum tolerated dose of CyberKnife radiation [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Active, not recruiting
15
Not Provided
October 2011   (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
Both
18 Years to 95 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00807339
2005P-00384
Yes
Irving Kaplan, MD, Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
Not Provided
Not Provided
Beth Israel Deaconess Medical Center
April 2011

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