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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
Sponsor:
Information provided by (Responsible Party):
Raquibul Hannan, University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE June 12, 2015
First Posted Date  ICMJE June 16, 2015
Last Update Posted Date March 8, 2021
Actual Study Start Date  ICMJE June 2015
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2020)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: June 15, 2015)
  • safety: Phase I: numbers of grade 4-5 adverse events experienced within the 90 days of the surgery that is attributable to the addition of SABR [ Time Frame: 90 daus ]
  • survival: Phase II: relapse-free survival [ Time Frame: ONE YEAR ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2020)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2015)
  • pulmonary emboli assessed by the rate of pulmonary emboli [ Time Frame: 5 years ]
  • recurrence assessed by median time to recurrence [ Time Frame: 5 years ]
  • Pulmonary metastasis [ Time Frame: 5 years ]
    The rate of pulmonary metastasis
  • Systemic metastasis [ Time Frame: 5 years ]
    the rate of systemic metastasis
  • Overall survival [ Time Frame: 5 years ]
    The rate of overall survival
  • Morbidity [ Time Frame: 90 days ]
    Numbers of associated peri-operative morbidity
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neo-adjuvant SABR for IVC Tumor Thrombus in Newly Diagnosed RCC
Official Title  ICMJE Safety Lead-in Phase II Trial of Neo-adjuvant SABR for IVC Tumor Thrombus in Newly Diagnosed RCC
Brief 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.

Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
6 for Lead-in phase; 23 for phase II
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Renal Cell Carcinoma
Intervention  ICMJE Radiation: Stereotactic ablative radiation therapy
SABR
Study Arms  ICMJE Experimental: Stereotactic ablative radiation therapy
SABR
Intervention: Radiation: Stereotactic ablative radiation therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 14, 2020)
29
Original Estimated Enrollment  ICMJE
 (submitted: June 15, 2015)
30
Estimated Study Completion Date  ICMJE December 30, 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sandra Morones 2146458525 Sandra.Morones@UTSouthwestern.edu
Contact: Sarah Hardee 2146458525 sarah.hardee@utsouthwestern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02473536
Other Study ID Numbers  ICMJE STU 022015-058
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Raquibul Hannan, University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Raquibul Hannan, MD UTSW
PRS Account University of Texas Southwestern Medical Center
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP