CyberKnife for Unresectable Renal Tumors

Renal Cancer Clinical Trial

Official title:

CyberKnife Stereotactic Radiation for Unresectable Renal Tumors/PhaseI Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00807339
• Other study ID #: 2005P00384
• Status: Completed
• Phase: N/A
• First received: December 10, 2008
• Last updated: March 20, 2017
• Start date: March 2006
• Est. completion date: August 20, 2014

Study information

• Verified date: March 2017
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: August 20, 2014
• Est. primary completion date: January 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Neoplasms
• Renal Cancer

Intervention

Radiation:
• Stereotactic radiation
Dose escalation three consecutive treatments

Device:
• CyberKnife Robotic Radiosurgery System

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the maximum tolerated dose of CyberKnife radiation		2 years
Secondary	To evaluate local control, overall survival and late toxicity including preservation of renal function		2 years