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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 : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief Summary:
Stereotactic Ablative Radiation Therapy (SABR): 5 fractions of 8 Gy or 3 fractions of 12Gy fro kidney tumor and tumor thrombus

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Radiation: Stereotactic ablative radiation therapy Phase 1 Phase 2

Detailed Description:
Neoadjuvant treatment of IVC-TT with SABR may decrease local recurrences and lower the likelihood of embolic complications and systemic metastasis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 2019
Estimated Study Completion Date : December 30, 2020


Arm Intervention/treatment
Experimental: Stereotactic ablative radiation therapy
SABR
Radiation: Stereotactic ablative radiation therapy
SABR




Primary Outcome Measures :
  1. 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 ]
  2. survival: Phase II: relapse-free survival [ Time Frame: one year ]

Secondary Outcome Measures :
  1. pulmonary emboli assessed by the rate of pulmonary emboli [ Time Frame: 5 years ]
  2. recurrence assessed by median time to recurrence [ Time Frame: 5 years ]
  3. pulmonary metastasis [ Time Frame: 5 years ]
    the rate of pulmonary metastasis

  4. systemic metastasis [ Time Frame: 5 years ]
    the rate of systemic metastasis

  5. overall survival [ Time Frame: 5 years ]
    the rate of overall survival

  6. morbidity [ Time Frame: 90 days ]
    numbers of associated peri-operative morbidity



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Raquibul Hannan, MD 214-645-8525
Contact: Satish Veerla, MS 214-648-1895 satish.veerla@UTSouthwestern.edu

Locations
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United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75239
Contact: Raquibul Hannan, MD    214-645-8525      
Contact: Jean Wu, MSN    214-645-8525      
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Raquibul Hannan, MD UTSW

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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02473536    
Other Study ID Numbers: STU 022015-058
First Posted: June 16, 2015    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases