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

Korábbi kezelés

• 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

Más betegség

• Subjects with a history of pulmonary embolism is excluded
• Subjects with a history of pulmonary hypertension is excluded

Laborértékek

• 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. Patients with one or more of these contraindications but eligible to undergo contrast-enhanced CT can participate in this study and will not receive an MRI

Egyéb

• Subjects with brain metastases should be excluded from this clinical trial unless all the metastasis are treated surgically or radio-surgically
• Subjects must not be pregnant due to the potential for congenital abnormalities.

• Radiographic evidence of renal cancer with IVC tumor thrombus
• Tumor thrombus must be ≥ level II (As per Mayo classification, it would be ≥ level I [Refer to NEVES, R. and ZINCKE, H. (1987), Surgical Treatment of Renal Cancer with Vena Cava Extension. British Journal of Urology, 59: 390-395. doi:10.1111/j.1464-410X.1987.tb04832.x])
• 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 Phase II, metastatic patients will be allowed only if all sites of metastasis has been treated either surgically or radio-surgically (If limited sites of metastasis are present, all of which can be resected during the nephrectomy, then the patient can be eligible)
• Age ≥ 18 years.
• Performance status ECOG 0-2
• Any serum Albumin is allowed, but ≥ 3.4 g/dL is strongly encouraged
  • Serum albumin <3.4 is a significant predictor of peri-operative mortality(12)
• Any serum AST is allowed but serum AST ≤ 34 IU/L is strongly encouraged
  • Significant predictor of mortality in univariate but not multivariate analysis(12)
• Women of childbearing potential and men must agree to use adequate contraception (hormonal such as birth control pills, patch or ring; Depo-Provera, Implanon or barrier method, such as condom or diaphragm used with a spermicide of birth control; abstinence) prior to study entry, for the duration of study treatment, and for 90 days following completion of radiation therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • 10.1 A female of childbearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
  • Has not undergone a hysterectomy or bilateral oophorectomy; or
  • Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
• Ability to understand and the willingness to sign a written informed consent.
• Subjects must be able to undergo either MRI or CT.