Neo-adjuvant SABR for IVC Tumor Thrombus in Newly Diagnosed RCC

Neoadjuvant treatment of IVC-TT with SABR may decrease local recurrences and lower the
likelihood of embolic complications and systemic metastasis.

Inclusion Criteria:

- Radiographic evidence of renal cancer with IVC tumor thrombus

- Tumor thrombus must be ≥ level II

- Patient eligible for SABR to the IVC tumor thrombus as decided by the treating
radiation oncologist

- Patient eligible for IVC tumor thrombectomy as decided by the treating urologist

- Any number of metastatic disease is allowed in the Pilot phase of the trial

- For the Phase II, metastatic patients will be allowed only if all sites of
metastasis has been treated either surgically or radio-surgically

- Age ≥ 18 years.

- Performance status ECOG 0-2

- Any serum Albumin is allowed, but ≥ 3.4 g/dL is strongly encouraged

- Any serum AST is allowed but serum AST ≤ 34 IU/L is strongly encouraged

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry, for
the duration of study participation, and for 90 days following completion of therapy.
Should a woman become pregnant or suspect she is pregnant while participating in this
study, she should inform her treating physician immediately.

- Ability to understand and the willingness to sign a written informed consent.

- Subjects must be able to undergo either a contrast enhanced MRI or CT.

Exclusion Criteria:

- Subjects who have had radiotherapy to a target within 3 cm of the IVC tumor thrombus.

- Subjects may have received any other investigational agents or chemotherapy as long as
they are eligible for SABR and surgery

- Subjects with brain metastases should be excluded from this clinical trial unless all
the metastasis are treated surgically or radio-surgically

- Subjects with a history of pulmonary embolism is excluded

- Subjects with a history of pulmonary hypertension is excluded

- Subjects must not be pregnant due to the potential for congenital abnormalities.

- Surgery or SABR of metastatic site concurrently or at any time is allowed

- Contraindication for contrast-enhanced MRI as defined by the standard operating
procedures of the Department of Radiology at UT Southwestern. Briefly, these include
medically unstable; cardiac pacemaker; intracranial clips, metal implants; metal in
the eyes; pregnant or nursing; claustrophobia; and impairment of the renal function
with estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2.