SABR for Renal Tumors

Overview

Renal Cell Carcinoma (RCC) is the most common type of kidney cancer. The usual treatment for this type of cancer is surgery. Considering the most common patients are an average age of 65 and some are not suitable candiates for surgery, there is great interest in non-surgical alternatives for kidney cancer treatments. This study will investigate the use of Stereotactic Ablative Radiosurgery (SABR) for renal tumors. SABR is a non-invasive alternative, which involves delivery of high doses of radiation to the target, while minimizing the risk of injury to the surrounding organs. Patients will be seen before and end of treatmetn and will be followed at 4 month intervals for up to 2 years. During the follow ups, patients will be asked to complete a quality of life questionnaire and will have standard of care imaging.

Full Title of Study: “Phase II Study: Stereotactic Ablative Radiotherapy for Renal Tumors”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2020

Interventions

  • Radiation: Stereotactic Ablative Radiotherapy
    • Stereotactic Ablative Radiotherapy to renal tumors with a dose of 27.5-40 Gy in 5 fractions.

Arms, Groups and Cohorts

  • Experimental: Stereotactic Ablative Radiotherapy
    • Adult patients with Kidney mass (either primary or metastasis) amenable to SABR

Clinical Trial Outcome Measures

Primary Measures

  • To evaluate the radiation induced renal impairments in patients receiving SABR.
    • Time Frame: 2 years
    • The prevalence of nephron toxicity in patients treated with SABR, measured by the change in Glomerular Filtration Rate (GFR) every 4 months over 2 years.

Secondary Measures

  • Chronic Kidney Disease Stage Progression
    • Time Frame: 2 years
    • Chronic kidney disease stage progression after SABR, assessed by the Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines
  • 2-year Local recurrence rate
    • Time Frame: 2 years
    • 2 year local recurrence rate of kidney tumors treated with SABR, measured by assessing the change of irradiated kidney function on functional imaging.
  • Patient Reported Outcomes
    • Time Frame: 2 years
    • The change in quality of life of patients treated with SABR, assessed through the use of NCCN FKSI-19 questionnaire.
  • Incidence of acute and late toxicities
    • Time Frame: 2 years
    • The incidence of acute (≤3 months) and late complication of interest (GI or GU complications, high blood pressure and adrenal insufficiency) as assessed by CTCAE version 5.0.

Participating in This Clinical Trial

Inclusion Criteria

  • Solid Kidney Mass (primary RCC or metastasis) amenable to SABR ≤6cm
  • Histological or radiological diagnosis of renal tumor
  • Inoperable: High risk for surgery or declined surgery
  • ECOG performance status of 0-3

Exclusion Criteria

  • ≥5 active metastases
  • Sysstemic therapy (except endocrine therapy) wthin 6 days prior to SABR
  • Prior abdominal radiotherapy with fields overlap resulting in excessive doses to the involved kidney
  • Patients with end stage renal failure > 4(KDOQI guidelines)
  • Familial Syndrome: Von Hippel-Lindau disease, Polycystic Kidney Disease, Hereditary Papillary RCC or Tuber Sclerosis

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Health Network, Toronto
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Joelle Helou, MD, Principal Investigator, University Health Network–Princess Margaret Cancer Centre
  • Overall Contact(s)
    • Joelle Helou, MD, 416-946-4501, joelle.helou@rmp.uhn.ca

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