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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
History of Changes
  Purpose

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 Intervention Phase
Renal Cancer
 Radiation: Stereotactic radiation
Device: CyberKnife Robotic Radiosurgery System
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CyberKnife Stereotactic Radiation for Unresectable Renal Tumors/PhaseI Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • To determine the maximum tolerated dose of CyberKnife radiation [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate local control, overall survival and late toxicity including preservation of renal function [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: March 2006
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Phase I dose escalation
 Radiation: Stereotactic radiation
Dose escalation three consecutive treatments
Device: CyberKnife Robotic Radiosurgery System

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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00807339

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

No publications provided

Responsible Party: Irving Kaplan, MD, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00807339     History of Changes
Other Study ID Numbers: 2005P-00384
Study First Received: December 10, 2008
Last Updated: April 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
CyberKnife

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

ClinicalTrials.gov processed this record on May 16, 2013