This phase II trial studies how well stereotactic body radiation therapy works in treating patients with kidney cancer that has spread to other places in the body (metastatic). Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.
PRIMARY OBJECTIVES: I. To evaluate the feasibility definitive radiation therapy (RT) (such as stereotactic body radiation therapy \[SBRT\]) as a treatment strategy for oligometastatic renal cell carcinoma (RCC) in lieu of systemic therapy. II. To estimate the progression free survival (PFS) after study enrollment utilizing a strategy of definitive local treatment to all sites of disease in oligometastatic and low metastatic burden RCC as measured by Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1). III. To determine the systemic therapy free survival after study enrollment SECONDARY OBJECTIVES: I. To determine the effect of definitive RT (SBRT) on cellular replication and death, measured by ki-67 staining and others. (Required in Cohort A, but optional in Cohort B) II. To estimate the overall survival at 12 months after study enrollment. III. To estimate the freedom from new lesion development at 12 months. IV. To determine the treatment related toxicities associated with definitive RT as part of definitive local therapy for oligometastatic and low volume metastatic RCC. EXPLORATORY OBJECTIVE: I. To determine the association of translational biomarkers including peripheral blood markers and tissue markers with patient outcomes. OUTLINE: Patients undergo SBRT over 1 day to 3 weeks based on the judgment of the treating radiation oncologist. If the disease spreads to a new lesion that can be treated with local therapy, patients may repeat SBRT over 1 day to 3 weeks based on the judgment of the treating radiation oncologist. Patients may undergo blood sample collection throughout the trial, as well as a tumor biopsy on study. Patients also undergo computed tomography (CT), positron emission tomography (PET)/CT, and/or magnetic resonance imaging (MRI) throughout the trial. After completion of study treatment, patients are followed up every 12 weeks for 1 year, and then every 18 weeks thereafter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
Undergo tumor biopsy
Undergo blood sample collection
Undergo CT and/or PET/CT
M D Anderson Cancer Center
Houston, Texas, United States
Feasibility of incorporating definitive radiation therapy (RT) (such as stereotactic body radiation therapy [SBRT]) into treatment plan for oligometastatic renal cell carcinoma (RCC) in lieu of systemic therapy
Defined as successful completion of all protocol-related treatment with \< 7 days of unplanned radiation treatment delays within 3 years of protocol activation.
Time frame: Up to 12 months
Feasibility of incorporating definitive RT (such as SBRT) as a treatment strategy for low metastatic burden RCC in lieu of systemic therapy
Defined as successful completion of all protocol-related treatment with \< 7 days of unplanned radiation treatment delays within 3 years of protocol approval.
Time frame: Up to 12 months
Progression-free survival (PFS) in oligometastatic RCC per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Serial assessment with radiographic imaging will be evaluated. The probabilities of participants remaining alive and progression free will be estimated using the Kaplan Meier method with corresponding 95% confidence intervals.
Time frame: At 12 months
PFS in low metastatic burden RCC per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Serial assessment with radiographic imaging will be evaluated. The probabilities of participants remaining alive and progression free will be estimated using the Kaplan Meier method with corresponding 95% confidence intervals.
Time frame: Up to 12 months
Systemic therapy free survival
The probabilities of patients remaining off systemic therapy at 12 months will be estimated utilizing the Kaplan Meier and model it as a function of potential prognostic factors using Cox proportional hazards regression.
Time frame: At 12 months
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TREATMENT
Masking
NONE
Enrollment
123
Undergo MRI
Undergo PET/CT
Undergo SBRT
Reduction in cellular replication as measured by ki-67 staining (Cohort A)
The number of cells with ki-67 staining per 10 high powered fields will be calculated in pre- and post SBRT samples. The percent difference in in ki-67 staining will be calculated by dividing the difference in pre- and post- ki67 staining by the pretreatment ki-67. Will estimate the median relative change with 95% confidence interval.
Time frame: Baseline up to 12 months
Overall survival
The probabilities of participants remaining alive will be estimated utilizing the Kaplan Meier method with corresponding 95% confidence intervals.
Time frame: At 12 months
Freedom from new lesion development
A participant will be considered to have a new lesion when standard radiographic imaging identifies a new lesion that is non-contiguous with any other lesions measured at baseline. The probabilities of patients remaining free from new lesions will be estimated utilizing the Kaplan Meier method with corresponding 95% confidence intervals.
Time frame: At 12 months
Treatment related toxicities associated with SBRT
The frequency of grade 2 and higher toxicities attributable to study treatment will be reported for all patients at all follow up visits.
Time frame: Up to 12 months