Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Kidney Cancer Undergoing Surgery

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: NCT01892930
Recruitment Status : Completed
First Posted : July 8, 2013
Last Update Posted : February 10, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

June 20, 2013
July 8, 2013
February 10, 2017
July 11, 2013
December 30, 2015   (Final data collection date for primary outcome measure)
Feasibility of conducting a partial nephrectomy in patients with no prior stereotactic radiation for kidney cancer [ Time Frame: Up to 30 days post-treatment ]
Changes in immune parameters such as CD4 and CD8 t cells, T-regulatory cells, natural killer cells, monocytes, macrophage, dendritic cells, and myeloid derived suppressor cells [ Time Frame: Baseline to 30 days ]
Complete list of historical versions of study NCT01892930 on Archive Site
Toxicity analysis assessed by the CTEP Version 4 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: Up to 30 days post-treatment ]
Not Provided
Not Provided
Not Provided
Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Kidney Cancer Undergoing Surgery
Immunologic Impact of Stereotactic Body Radiation Therapy (SBRT) in Renal Cell Carcinoma
This pilot clinical trial studies stereotactic body radiation therapy in treating patients with metastatic kidney cancer undergoing surgery. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.


I. Assess the impact of stereotactic body radiation therapy (SBRT) on the immune system in patients with metastatic renal cell carcinoma (RCC).


I. Assess changes in immune parameters prior to radiation, post radiation and post nephrectomy.


I. Assess surgical parameters for partial or radical nephrectomy post SBRT.


Patients undergo SBRT on day 1 and undergo partial or radical nephrectomy on day 29.

After completion of study treatment, patients are followed up at 30 days.

Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Recurrent Renal Cell Cancer
  • Stage IV Renal Cell Cancer
  • Radiation: stereotactic body radiation therapy
    Undergo SBRT
    Other Names:
    • SBRT
    • stereotactic radiation therapy
    • stereotactic radiotherapy
  • Procedure: therapeutic conventional surgery
    Undergo partial or radical nephrectomy
  • Other: laboratory biomarker analysis
    Correlative studies
Experimental: Treatment (SBRT, nephrectomy)
Patients undergo SBRT on day 1 and undergo partial or radical nephrectomy on day 29.
  • Radiation: stereotactic body radiation therapy
  • Procedure: therapeutic conventional surgery
  • Other: laboratory biomarker analysis
Singh AK, Winslow TB, Kermany MH, Goritz V, Heit L, Miller A, Hoffend NC, Stein LC, Kumaraswamy LK, Warren GW, Bshara W, Odunsi K, Matsuzaki J, Abrams SI, Schwaab T, Muhitch JB. A Pilot Study of Stereotactic Body Radiation Therapy Combined with Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma. Clin Cancer Res. 2017 Sep 1;23(17):5055-5065. doi: 10.1158/1078-0432.CCR-16-2946. Epub 2017 Jun 19.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 30, 2016
December 30, 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have metastatic RCC with primary tumor in place
  • Must be surgical candidates as deemed fit by surgeon
  • Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria present
  • Patients of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
  • Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

  • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Radiation to primary tumor prior to enrollment in this study
  • Pregnant or nursing female patients
  • Unwilling or unable to follow protocol requirements
  • Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive treatment
  • Received an investigational agent within 30 days prior to enrollment
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
I 212712
NCI-2013-01201 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA016056 ( U.S. NIH Grant/Contract )
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Roswell Park Cancer Institute
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Principal Investigator: Thomas Schwaab Roswell Park Cancer Institute
Roswell Park Cancer Institute
February 2017

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