Stereotactic Ablative Body Radiation Therapy for Patients With Primary Renal Cancer

Overview

The goal of this phase II clinical trial is to evaluate the efficacy of the completely non-invasive treatment option of stereotactic radiation therapy for the treatment of biopsy proven and growing small renal tumors.

Full Title of Study: “A Phase II Trial of Stereotactic Ablative Body Radiation Therapy (SABR) for Patients With Primary Renal Cancer (RCC)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2019

Detailed Description

Current treatment options for primary renal cancer include surgery or ablative techniques—all are invasive or minimally invasive options. The completely noninvasive treatment option of stereotactic radiation therapy (SABR), which has become standard of care in many cancer sites, has not been explored for primary renal cancer. With multiple technological advances, it is now feasible to safely treat a moving intra-abdominal tumor such as that in a kidney. This proposed clinical trial evaluates the efficacy of SABR in treating patients with early renal cancers. Growing renal masses will first be biopsied to confirm the diagnosis of renal cancer. Patients will then undergo treatment with SABR of 3-5 fractions completing within three weeks. Treatment response will be evaluated using sequential MRI scans and a second tumor biopsy one year after treatment. Monitoring of treatment toxicity and kidney function will also be performed.

Interventions

  • Radiation: Stereotactic Ablative Radiation Therapy
    • Stereotactic Ablative Body Radiation Therapy (SABR): 3 fractions of 12Gy, or 4 fractions of 10Gy or 5 fractions of 8 Gy

Arms, Groups and Cohorts

  • Experimental: Stereotactic Ablative Radiation Therapy
    • Stereotactic Ablative Radiation Therapy (SABR)

Clinical Trial Outcome Measures

Primary Measures

  • Eliminate its growth and tumor viability.
    • Time Frame: 2 years
    • To evaluate if SABR to small renal tumors is able to eliminate its growth and viable tumor.

Secondary Measures

  • Adverse events
    • Time Frame: 2 years
    • To describe the adverse events associated with the administration of SABR to renal tumors.
  • growth rate of renal tumors
    • Time Frame: 2 years
    • To measure the growth rate of renal tumors after SABR treatment.
  • Renal function
    • Time Frame: 2 years
    • To measure the changes in kidney function, creatinine levels, renal perfusion and GFR after SABR treatment
  • Tumor Viability
    • Time Frame: one year
    • To measure tumor viability pathologically one year after SABR treatment.
  • progression of disease
    • Time Frame: 2 years
    • To assess local, regional and systemic progression of disease after SABR to renal tumors

Participating in This Clinical Trial

Inclusion Criteria

  • Age ≥ 18 years.
  • Renal mass ≤ 3cm
  • Biopsy proven Renal neoplasm
  • All histology of renal cancers are included including oncocytoma
  • Growth of renal mass >4mm in radiographic scans or >2mm in two different scans must be demonstrated within a one year period.
  • Ability to understand and the willingness to sign a written informed consent.
  • No clinical evidence of metastatic disease

Exclusion Criteria

  • Subjects may not have received any treatment for the renal mass before such as RFA or cryoablation.
  • Subjects must not have received previous abdominal radiation
  • Subjects must be able to undergo either an MRI or administration of contrast agent for CT.
  • Subjects unable to undergo either of the imaging study will be excluded.
  • Subjects enrolled on the study and then became unable to undergo either of the imaging study will be either replaced or decided on an individual basis by the investigator (please see section 5.5)
  • Subjects must not be pregnant during the course of SABR.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Texas Southwestern Medical Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Raquibul Hannan, MD, PhD, Principal Investigator, UTSW
  • Overall Contact(s)
    • Raquibul Hannan, MD, PhD, 214-645-8525

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