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CyberKnife Stereotactic Radiation for Unresectable Renal Tumors/PhaseI Study


Phase 1
18 Years
95 Years
Open (Enrolling)
Both
Renal Cancer

Thank you

Trial Information

CyberKnife Stereotactic Radiation for Unresectable Renal Tumors/PhaseI 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose of CyberKnife radiation

Outcome Time Frame:

2 years

Safety Issue:

Yes

Authority:

United States: Institutional Review Board

Study ID:

2005P-00384

NCT ID:

NCT00807339

Start Date:

March 2006

Completion Date:

Related Keywords:

  • Renal Cancer
  • CyberKnife
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215