This trial is active, not recruiting.

Condition renal cancer
Treatments stereotactic radiation, cyberknife robotic radiosurgery system
Phase phase 1
Sponsor Beth Israel Deaconess Medical Center
Start date March 2006
End date October 2011
Trial size 15 participants
Trial identifier NCT00807339, 2005P-00384


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Phase I dose escalation
stereotactic radiation
Dose escalation three consecutive treatments
cyberknife robotic radiosurgery system

Primary Outcomes

To determine the maximum tolerated dose of CyberKnife radiation
time frame: 2 years

Secondary Outcomes

To evaluate local control, overall survival and late toxicity including preservation of renal function
time frame: 2 years

Eligibility Criteria

Male or female participants from 18 years up to 95 years old.

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

Additional Information

Official title CyberKnife Stereotactic Radiation for Unresectable Renal Tumors/PhaseI Study
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2011.
Information provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center.