CyberKnife for Unresectable Renal Tumors

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. Identifier: NCT00807339
Recruitment Status : Completed
First Posted : December 11, 2008
Last Update Posted : March 21, 2017
Information provided by (Responsible Party):
Irving Kaplan, Beth Israel Deaconess Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Renal Cancer Radiation: Stereotactic radiation Device: CyberKnife Robotic Radiosurgery System Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CyberKnife Stereotactic Radiation for Unresectable Renal Tumors/PhaseI Study
Actual Study Start Date : March 2006
Actual Primary Completion Date : January 1, 2014
Actual Study Completion Date : August 20, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer

Arm Intervention/treatment
Experimental: 1
Phase I dose escalation
Radiation: Stereotactic radiation
Dose escalation three consecutive treatments

Device: CyberKnife Robotic Radiosurgery System

Primary Outcome Measures :
  1. To determine the maximum tolerated dose of CyberKnife radiation [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. To evaluate local control, overall survival and late toxicity including preservation of renal function [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00807339

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center

Responsible Party: Irving Kaplan, Assistant Professor of Radiation Oncology, Beth Israel Deaconess Medical Center Identifier: NCT00807339     History of Changes
Other Study ID Numbers: 2005P00384
First Posted: December 11, 2008    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Irving Kaplan, Beth Israel Deaconess Medical Center:

Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type