CyberKnife for Unresectable Renal Tumors

Beth Israel Deaconess Medical Center17 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Renal Cancer

Interventions

Stereotactic radiationRADIATION

Dose escalation three consecutive treatments

CyberKnife Robotic Radiosurgery SystemDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 95 Years

Medical Language ↔ Plain English

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

Locations (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Outcomes

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

Data from ClinicalTrials.gov

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