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

Study ID
STU 022015-058

Study Sites

  • Clements University Hospital

Contact
Patrick Brooks
214/645-2250
Patrick.Brooks@UTSouthwestern.edu

Principal Investigator
Raquibul Hannan, M.D., Ph.D.

Official Title

Safety Lead-in Phase II Trial of Neo-adjuvant SABR for IVC Tumor Thrombus in Newly Diagnosed RCC

Brief Overview

Stereotactic Ablative Radiation Therapy (SABR): 5 fractions of 8 Gy or 3 fractions of 12Gy fro kidney tumor and tumor thrombus

Description

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

Eligibility

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.