CyberKnife for Unresectable Renal Tumors

CyberKnife Stereotactic Radiation for Unresectable Renal Tumors/PhaseI Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00807339

Enrollment

Registered

2008-12-11

Start date

2006-03-31

Completion date

2014-08-20

Last updated

2017-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Cancer

Keywords

CyberKnife

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.

Interventions

RADIATIONStereotactic radiation

Dose escalation three consecutive treatments

DEVICECyberKnife Robotic Radiosurgery System

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 95 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To determine the maximum tolerated dose of CyberKnife radiation	2 years

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026