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

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Kidney Cancer Radiation: stereotactic radiosurgery Procedure: Renal Biopsy Procedure: Serum Blood Markers Not Applicable

Detailed Description:



  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of a Radio-Surgical Approach for the Treatment of Kidney Tumors in Poor Surgical Candidates
Actual Study Start Date : February 20, 2007
Estimated Primary Completion Date : July 17, 2018
Estimated Study Completion Date : July 17, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer

Arm Intervention/treatment
Experimental: Stereotactic radiosurgery 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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: at 36 months from start of therapy ]
    Number of patients still alive after study completion

  2. Disease-free survival [ Time Frame: at 36 months from start of therapy ]
  3. Time to local progression [ Time Frame: at 36 months from start of therapy ]
  4. Time to distant failure (Phase II) [ Time Frame: at 36 months from start of therapy ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00458484

United States, Ohio
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
UH-Chagrin Highlands
Orange Village, Ohio, United States, 44122
Westlake, Ohio, United States, 44145
Sponsors and Collaborators
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

Responsible Party: Case Comprehensive Cancer Center Identifier: NCT00458484     History of Changes
Other Study ID Numbers: CASE12806
P30CA043703 ( U.S. NIH Grant/Contract )
CASE12806 ( Other Identifier: Case Comprehensive Cancer Center )
NCI-2010-01064 ( Other Identifier: NCI/CTRP )
First Posted: April 11, 2007    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018

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

Keywords provided by Case Comprehensive Cancer Center:
stage I renal cell cancer
stage II renal cell cancer
stage III renal cell cancer
stage IV renal cell cancer

Additional relevant MeSH terms:
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases