Radiosurgery in Treating Patients With Kidney Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00458484
Recruitment Status : Active, not recruiting
First Posted : April 11, 2007
Last Update Posted : January 24, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

April 9, 2007
April 11, 2007
January 24, 2018
February 20, 2007
July 17, 2018   (Final data collection date for primary outcome measure)
Maximum tolerated dose of radiosurgery (Phase I) [ Time Frame: once every 4 weeks ]
Acute Radiation Toxicity ≥ grade 3 in the Gastrointestinal and renal/genitourinary categories of the common terminology criteria for adverse events 4.0 (CTCAE) will be considered dose limiting. The maximum tolerated dose will be one dose level below which the adverse event, as described above, occurred.
Maximum tolerated dose of radiosurgery
Complete list of historical versions of study NCT00458484 on Archive Site
  • Overall survival [ Time Frame: at 36 months from start of therapy ]
    Number of patients still alive after study completion
  • Disease-free survival [ Time Frame: at 36 months from start of therapy ]
  • Time to local progression [ Time Frame: at 36 months from start of therapy ]
  • Time to distant failure (Phase II) [ Time Frame: at 36 months from start of therapy ]
  • Overall survival
  • Disease-free survival
  • Time to local progression
  • Time to distant failure
Not Provided
Not Provided
Radiosurgery in Treating Patients With Kidney Tumors
Evaluation of a Radio-Surgical Approach for the Treatment of Kidney Tumors in Poor Surgical Candidates

RATIONALE: Radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: This phase I/II trial studies the side effects and best dose of giving stereotactic radiosurgery and to see how well it works in treating patients with kidney tumors who are poor candidates for surgery.



  • To evaluate and compare the clinical safety of utilizing four different schemes of radiosurgical ablative techniques for treating poor surgical candidates with renal tumors.


  • To evaluate and compare the clinical and radiographic efficacy of four different schemes of radiosurgical ablation of renal tumors in poor surgical candidates.

Serum Blood Marker Objective:

  • To determine if serum markers collected before and after radiation may give a predictive indication of tumor response.

OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.

Patients undergo placement of 2-3 fiducial markers in or near the renal tumor. Patients then undergo 4 fractions of stereotactic radiosurgery in the absence of disease progression or unacceptable toxicity. Treatment may repeat at 6 months if tumor is still present.

After radio-surgery, follow-up will be done at 1 , 3 and 6 months and then every 6 months post radiosurgery for a total of 36 months.

PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.

Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Kidney Cancer
  • Radiation: stereotactic radiosurgery

    Series I: Radiation will be delivered in 4 fractions. The initial dose level will be 6 Gy per fraction to a total dose of 24 Gy in 4 fractions. Doses will be escalated at 2 Gy per fraction increments to 12 Gy per fraction to a total dose of 48 Gy. The radiation treatment planning and evaluation details are appended.

    Series II: The initial dose level will be 48 Gy to the target volume (tumor) in 3 fractions of 16 Gy per fraction. If acute toxicity is acceptable, then the next four patients will be escalated to 54 Gy in 3 fractions of 18 Gy. Finally if a dose limit has not been reached, the last group of four patients will be treated to 60 Gy in 3 fractions of 20 Gy each.

  • Procedure: Renal Biopsy
    At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
  • Procedure: Serum Blood Markers
    ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.
Experimental: Stereotactic radiosurgery
  • Radiation: stereotactic radiosurgery
  • Procedure: Renal Biopsy
  • Procedure: Serum Blood Markers
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
Same as current
July 17, 2018
July 17, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient is considered a poor surgical candidate for removal of renal mass as determined by anesthesiology pre-operative assessment or the surgical team, medical team. (No major psychiatric illnesses.)
  • Patient is able to give and sign study specific informed consent
  • No prior radiation to the treatment field
  • Negative serum or urine pregnancy test within 72 hours prior to registration for women of childbearing potential
  • Patient has a radiologically and /or pathologically confirmed diagnosis of a renal tumor
  • Karnofsky status of ≥ 60%
  • Signed study-specific informed consent prior to study entry

Exclusion Criteria:

  • Any patient not meeting the eligibility criteria.
  • Any patient with active connective tissue disease such as lupus, dermatomyositis.
  • Any patient with active Crohn's disease or active ulcerative colitis.
  • Major psychiatric illness, which would prevent completion of treatment or interfere with follow-up.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
P30CA043703 ( U.S. NIH Grant/Contract )
CASE12806 ( Other Identifier: Case Comprehensive Cancer Center )
NCI-2010-01064 ( Other Identifier: NCI/CTRP )
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Not Provided
Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Rodney Ellis, MD University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP