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

Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02473536
• Other study ID #: STU 022015-058
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: June 2015
• Est. completion date: January 2025

Study information

• Verified date: January 2024
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Radiographic evidence of renal cancer with IVC tumor thrombus

2. 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])

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

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

5. 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)

6. Age = 18 years.

7. Performance status ECOG 0-2

8. 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)

9. 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)

10. 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).

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

12. Subjects must be able to undergo either MRI or CT.

Exclusion Criteria:

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

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

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

4. Subjects with a history of pulmonary embolism is excluded

5. Subjects with a history of pulmonary hypertension is excluded

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

7. 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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Radiation:
• Stereotactic ablative radiation therapy
SABR

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the feasibility of neoadjuvant SABR followed immediately by IVC tumor thrombectomy	The treatment duration will be between 2-3 weeks depending on the fraction scheme chosen.	90 days
Primary	To determine the operative safety of neoadjuvant SABR followed immediately by IVC tumor thrombectomy	The treatment duration will be between 2-3 weeks depending on the fraction scheme chosen.	90 days
Primary	Survival at one year	Phase II To determine the relapse-free survival at one-year	ONE YEAR
Secondary	Peri-operative morbidity	To describe the associated peri-operative morbidity. Associated peri-operative morbidity is defined as grade>2 side effects as assessed by NCI's CTCAE v4.0 toxicity within one year of surgery.	90 days
Secondary	Adverse events post surgery	To determine the associated adverse events within one year of surgery. Associated adverse events are any toxicity as defined by NCI's CTCAE v4.0 toxicity criteria for the first year post- surgery.	1 year
Secondary	Recurrence free survival (1 year)	To determine the 1 year recurrence free survival	1 year
Secondary	Recurrence free survival overall	To determine the recurrence free survival	7 years
Secondary	Recurrence	To determine the median time to recurrence	7 years
Secondary	Pulmonary emboli	To determine the rate of pulmonary emboli within one year of surgery. Pulmonary Emboli: Pulmonary embolus determined in patients that become symptomatic and as a result has radiographic evidence of pulmonary embolus on CT angio or V/Q scan.	1 year
Secondary	Pulmonary metastasis	To determine the rate of pulmonary metastasis. Pulmonary Metastasis: Any evidence of new lung metastasis >1.0 cm; • New lung nodules >0.5cm will also be reported.	7 years
Secondary	Systemic metastasis	To determine the rate of systemic metastasis. Systemic Metastasis: Any evidence of new metastasis that is progressing on a second scan > 6 weeks apart	7 years
Secondary	Overall survival	The rate of overall survival. Overall Survival: Time to death from the date of treatment start.	7 years