Neo-adjuvant SABR for IVC Tumor Thrombus in Newly Diagnosed RCC
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|ClinicalTrials.gov Identifier: NCT02473536|
Recruitment Status : Recruiting
First Posted : June 16, 2015
Last Update Posted : March 8, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma||Radiation: Stereotactic ablative radiation therapy||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||6 for Lead-in phase; 23 for phase II|
|Masking:||None (Open Label)|
|Official Title:||Safety Lead-in Phase II Trial of Neo-adjuvant SABR for IVC Tumor Thrombus in Newly Diagnosed RCC|
|Actual Study Start Date :||June 2015|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 30, 2021|
Experimental: Stereotactic ablative radiation therapy
Radiation: Stereotactic ablative radiation therapy
- To determine the feasibility of neoadjuvant SABR followed immediately by IVC tumor thrombectomy [ Time Frame: 90 days ]The treatment duration will be between 2-3 weeks depending on the fraction scheme chosen.
- To determine the operative safety of neoadjuvant SABR followed immediately by IVC tumor thrombectomy [ Time Frame: 90 days ]The treatment duration will be between 2-3 weeks depending on the fraction scheme chosen.
- Survival at one year [ Time Frame: ONE YEAR ]Phase II To determine the relapse-free survival at one-year
- Peri-operative morbidity [ Time Frame: 90 days ]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.
- Adverse events post surgery [ Time Frame: 1 year ]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.
- Recurrence free survival (1 year) [ Time Frame: 1 year ]To determine the 1 year recurrence free survival
- Recurrence free survival overall [ Time Frame: 5 years ]To determine the recurrence free survival
- Recurrence [ Time Frame: 5 years ]To determine the median time to recurrence
- Pulmonary emboli [ Time Frame: 1 year ]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.
- Pulmonary metastasis [ Time Frame: 5 years ]
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.
- Systemic metastasis [ Time Frame: 5 years ]To determine the rate of systemic metastasis. Systemic Metastasis: Any evidence of new metastasis that is progressing on a second scan > 6 weeks apart
- Overall survival [ Time Frame: 5 years ]The rate of overall survival. Overall Survival: Time to death from the date of treatment start.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02473536
|Contact: Sandra Morones||2146458525||Sandra.Morones@UTSouthwestern.edu|
|Contact: Sarah Hardeefirstname.lastname@example.org|
|United States, Texas|
|University of Texas Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75239|
|Contact: Raquibul Hannan, MD 214-645-8525|
|Contact: Sarah Hardee, MS 2146458525 Sarah.Hardee@UTSouthwestern.edu|
|Principal Investigator:||Raquibul Hannan, MD||UTSW|