Skip to main content
OpenTrials
Completed

NCT Number: NCT00807339

CyberKnife for Unresectable Renal Tumors

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Renal Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stereotactic Radiation

Radiation

Dose escalation three consecutive treatments

CyberKnife Robotic Radiosurgery System

Device

Primary outcomes

  1. To determine the maximum tolerated dose of CyberKnife radiation

    Time frame: 2 years

Secondary outcomes

  1. To evaluate local control, overall survival and late toxicity including preservation of renal function

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

CyberKnife Stereotactic Radiation for Unresectable Renal Tumors/PhaseI Study

Important dates

Study start
2006
Primary completion
2014
Study completion
2014
First posted
Dec 11, 2008
Registry last updated
Mar 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.