Back to resultsCyberKnife for Unresectable Renal Tumors
Primary Purpose
Renal Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stereotactic radiation
CyberKnife Robotic Radiosurgery System
Sponsored by
About this trial
This is an interventional treatment trial for Renal Cancer focused on measuring CyberKnife
Eligibility 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
Sites / Locations
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Phase I dose escalation
Outcomes
Primary Outcome Measures
To determine the maximum tolerated dose of CyberKnife radiation
Secondary Outcome Measures
To evaluate local control, overall survival and late toxicity including preservation of renal function
Full Information
NCT ID
NCT00807339
First Posted
December 10, 2008
Last Updated
March 20, 2017
Sponsor
Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00807339
Brief Title
CyberKnife for Unresectable Renal Tumors
Official Title
CyberKnife Stereotactic Radiation for Unresectable Renal Tumors/PhaseI Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2006 (Actual)
Primary Completion Date
January 1, 2014 (Actual)
Study Completion Date
August 20, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cancer
Keywords
CyberKnife
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Phase I dose escalation
Intervention Type
Radiation
Intervention Name(s)
Stereotactic radiation
Intervention Description
Dose escalation three consecutive treatments
Intervention Type
Device
Intervention Name(s)
CyberKnife Robotic Radiosurgery System
Primary Outcome Measure Information:
Title
To determine the maximum tolerated dose of CyberKnife radiation
Time Frame
2 years
Secondary Outcome Measure Information:
Title
To evaluate local control, overall survival and late toxicity including preservation of renal function
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
CyberKnife for Unresectable Renal Tumors
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