A Phase II Study of Cyberknife Radiosurgery for Renal Cell Carcinoma

Introduction

• Org Study ID: 12-235
• NTC ID: NCT01890590
• Lead Sponsor Name: Beth Israel Deaconess Medical Center
• Status: RECRUITING

Conditions

• Renal Cell Carcinoma

Brief Summary

CyberKnife Based Radiosurgery is a way to deliver large doses of radiation very accurately to a tumor. The ability of this technology to minimize radiation dose to organs adjacent to the target tumor allows a high dose to be delivered to the tumor, thus potentially increasing the efficacy of radiation treatment. Currently, radiosurgery is commonly used for brain metastases, Stage I lung cancer, spine tumors, and localized prostate cancer. The purpose of this protocol is to evaluate the role of Radiosurgery for the treatment of clinically localized primary renal cell carcinoma.

Eligibility Criteria

Inclusion Criteria:

* Participants must meet the following criteria on screening examination to be eligible to participate in the study:
* Participants must have histologically or radiological evidence of Stage I (T1N0M0) renal cell carcinoma with a size no larger than 8 cm in greatest dimension measured by MRI or CT Scan
* At least one (usually up to 3) gold fiducial placed in or around tumor, can be performed on the same day - after signing research informed consent.
* No irreversible coagulopathies
* Age ≥ 18 years old because no dosing or adverse event data are currently available on the use of Cyberknife Radiosurgery radiation in participants