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Trial record 1 of 1 for:    Safety Lead-in Phase II Trial of Neo-adjuvant SABR for IVC Tumor Thrombi in Newly Diagnosed RCC
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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 9, 2020
Sponsor:
Information provided by (Responsible Party):
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 9, 2020
Actual Study Start Date  ICMJE June 2015
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 2, 2019)
  • 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 days ]
  • survival: Phase II: relapse-free survival [ Time Frame: 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: 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
Original Secondary Outcome Measures  ICMJE Same as current
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 Stereotactic Ablative Radiation Therapy (SABR): 5 fractions of 8 Gy or 3 fractions of 12Gy fro kidney tumor and tumor thrombus
Detailed Description 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 Intervention Model: Single Group Assignment
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: June 15, 2015)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2024
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Radiographic evidence of renal cancer with IVC tumor thrombus
  • Tumor thrombus must be ≥ level II
  • 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 the Phase II, metastatic patients will be allowed only if all sites of metastasis has been treated either surgically or radio-surgically
  • Age ≥ 18 years.
  • Performance status ECOG 0-2
  • Any serum Albumin is allowed, but ≥ 3.4 g/dL is strongly encouraged
  • Any serum AST is allowed but serum AST ≤ 34 IU/L is strongly encouraged
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign a written informed consent.
  • Subjects must be able to undergo either a contrast enhanced MRI or CT.

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.
  • Surgery or SABR of metastatic site concurrently or at any time is allowed
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Raquibul Hannan, MD 214-645-8525
Contact: Satish Veerla, MS 214-648-1895 satish.veerla@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 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 January 2020

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