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

STATUS

Recruiting
End date

Dec 30, 2022
participants needed

29
sponsor

University of Texas Southwestern Medical Center

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Updated on 5 January 2022

See if I qualify

cancer

tubal ligation

metastasis

kidney tumor

kidney cancer

nephrectomy

Summary

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.

Description

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.

Details

Condition	Renal Cell Carcinoma
Treatment	Stereotactic ablative radiation therapy
Clinical Study Identifier	NCT02473536
Sponsor	University of Texas Southwestern Medical Center
Last Modified on	5 January 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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
	analysis(12)
	• Significant predictor of mortality in univariate but not multivariate
	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
	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)
	1 A female of childbearing potential is any woman (regardless of sexual
	Ability to understand and the willingness to sign a written informed consent
	Subjects must be able to undergo either MRI or CT
	orientation, marital status, having undergone a tubal ligation, or remaining
	Has not undergone a hysterectomy or bilateral oophorectomy; or
	celibate by choice) who meets the following criteria
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
	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

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