To evaluate the safety and feasibility of pre-operative SABR of RCC IVC tumor thrombus. To evaluate the effect of pre-operative SABR in RCC IVC tumor thrombus on relapse free survival at one year.
Stereotactic Ablative Radiation Therapy (SABR): 5 fractions of 8 Gy or 3 fractions of 12Gy. The concept of stereotactic radiosurgery involves tightly conforming dose of therapeutic radiation confined to a small region of the body. This results in eradication or ablation of the target tumor with sparing of surrounding normal tissues. The largest experience with stereotactic radiosurgery is for the treatment of intracranial tumors Neoadjuvant treatment of IVC-TT with SABR may decrease local recurrences and lower the likelihood of embolic complications and systemic metastasis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
SABR
University of Texas Southwestern Medical Center
Dallas, Texas, United States
To determine the feasibility of neoadjuvant SABR followed immediately by IVC tumor thrombectomy
The treatment duration will be between 2-3 weeks depending on the fraction scheme chosen.
Time frame: 90 days
To determine the operative safety of neoadjuvant SABR followed immediately by IVC tumor thrombectomy
The treatment duration will be between 2-3 weeks depending on the fraction scheme chosen.
Time frame: 90 days
Survival at one year
Phase II To determine the relapse-free survival at one-year
Time frame: ONE YEAR
Peri-operative morbidity
To describe the associated peri-operative morbidity. Associated peri-operative morbidity is defined as grade\>2 side effects as assessed by NCI's CTCAE v4.0 toxicity within one year of surgery.
Time frame: 90 days
Adverse events post surgery
To determine the associated adverse events within one year of surgery. Associated adverse events are any toxicity as defined by NCI's CTCAE v4.0 toxicity criteria for the first year post- surgery.
Time frame: 1 year
Recurrence free survival (1 year)
To determine the 1 year recurrence free survival
Time frame: 1 year
Recurrence free survival overall
To determine the recurrence free survival
Time frame: 7 years
Recurrence
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To determine the median time to recurrence
Time frame: 7 years
Pulmonary emboli
To determine the rate of pulmonary emboli within one year of surgery. Pulmonary Emboli: Pulmonary embolus determined in patients that become symptomatic and as a result has radiographic evidence of pulmonary embolus on CT angio or V/Q scan.
Time frame: 1 year
Pulmonary metastasis
To determine the rate of pulmonary metastasis. Pulmonary Metastasis: Any evidence of new lung metastasis \>1.0 cm • New lung nodules \>0.5cm will also be reported.
Time frame: 7 years
Systemic metastasis
To determine the rate of systemic metastasis. Systemic Metastasis: Any evidence of new metastasis that is progressing on a second scan \> 6 weeks apart
Time frame: 7 years
Overall survival
The rate of overall survival. Overall Survival: Time to death from the date of treatment start.
Time frame: 7 years