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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Roswell Park Cancer Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01892930
First received: June 20, 2013
Last updated: August 6, 2014
Last verified: August 2014

June 20, 2013
August 6, 2014
July 2013
August 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01892930 on ClinicalTrials.gov 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 ] [ Designated as safety issue: Yes ]
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.

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

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

TERTIARY OBJECTIVES:

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

OUTLINE:

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
Interventions:
  • Radiation: stereotactic body radiation therapy
  • Procedure: therapeutic conventional surgery
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
Not Provided
August 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
Both
18 Years and older
No
United States
 
NCT01892930
I 212712, NCI-2013-01201, P30CA016056
Yes
Roswell Park Cancer Institute
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Principal Investigator: Thomas Schwaab Roswell Park Cancer Institute
Roswell Park Cancer Institute
August 2014

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