Dallas, Texas 75239


Purpose:

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


Study summary:

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


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.


NCT ID:

NCT02473536


Primary Contact:

Principal Investigator
Raquibul Hannan, MD
UTSW

Raquibul Hannan, MD
Phone: 214-645-8525


Backup Contact:

Jean Wu, RN, MSN, OCN
Phone: 214-645-8525


Location Contact:

Dallas, Texas 75239
United States

Raquibul Hannan, MD
Phone: 214-645-8525

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 21, 2017

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