Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Kidney Cancer Undergoing Surgery
- Conditions
- Stage IV Renal Cell CancerRecurrent Renal Cell Cancer
- Interventions
- Radiation: stereotactic body radiation therapyProcedure: therapeutic conventional surgeryOther: laboratory biomarker analysis
- Registration Number
- NCT01892930
- Lead Sponsor
- Roswell Park Cancer Institute
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment (SBRT, nephrectomy) therapeutic conventional surgery Patients undergo SBRT on day 1 and undergo partial or radical nephrectomy on day 29. Treatment (SBRT, nephrectomy) stereotactic body radiation therapy Patients undergo SBRT on day 1 and undergo partial or radical nephrectomy on day 29. Treatment (SBRT, nephrectomy) laboratory biomarker analysis Patients undergo SBRT on day 1 and undergo partial or radical nephrectomy on day 29.
- Primary Outcome Measures
Name Time Method Feasibility of conducting a partial nephrectomy in patients with no prior stereotactic radiation for kidney cancer Up to 30 days post-treatment
- Secondary Outcome Measures
Name Time Method Toxicity analysis assessed by the CTEP Version 4 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) Up to 30 days post-treatment
Trial Locations
- Locations (1)
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States