Neo-adjuvant SABR for IVC Tumor Thrombus in Newly Diagnosed RCC
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 99 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.