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