CyberKnife for Unresectable Renal Tumors

NCT ID: NCT00807339

Last Updated: 2017-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2014-08-20

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.

Conditions

Renal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Phase I dose escalation

Group Type: EXPERIMENTAL

Stereotactic radiation

Intervention Type: RADIATION

Dose escalation three consecutive treatments

CyberKnife Robotic Radiosurgery System

Intervention Type: DEVICE

Interventions

Stereotactic radiation

Dose escalation three consecutive treatments

Intervention Type: RADIATION

CyberKnife Robotic Radiosurgery System

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Irving Kaplan

Assistant Professor of Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2005P00384

Identifier Type: -

Identifier Source: org_study_id