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CyberKnife for Unresectable Renal Tumors

Sponsor
Beth Israel Deaconess Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00807339
Collaborator
(none)
17
Enrollment
1
Location
1
Arm
101.7
Actual Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Radiation: Stereotactic radiation
  • Device: CyberKnife Robotic Radiosurgery System
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
N/A
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 :
Mar 1, 2006
Actual Primary Completion Date :
Jan 1, 2014
Actual Study Completion Date :
Aug 20, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Phase I dose escalation

Radiation: Stereotactic radiation
Dose escalation three consecutive treatments

Device: CyberKnife Robotic Radiosurgery System

Outcome Measures

Primary Outcome Measures

  1. To determine the maximum tolerated dose of CyberKnife radiation [2 years]

Secondary Outcome Measures

  1. To evaluate local control, overall survival and late toxicity including preservation of renal function [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 95 Years
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215

Sponsors and Collaborators

  • Beth Israel Deaconess Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Irving Kaplan, Assistant Professor of Radiation Oncology, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00807339
Other Study ID Numbers:
  • 2005P00384
First Posted:
Dec 11, 2008
Last Update Posted:
Mar 21, 2017
Last Verified:
Mar 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
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, Assistant Professor of Radiation Oncology, Beth Israel Deaconess Medical Center
CyberKnife
Additional relevant MeSH terms:
Kidney Neoplasms

Study Results

No Results Posted as of Mar 21, 2017