SABR for Renal Tumors

Phase II Study: Stereotactic Ablative Radiotherapy for Renal Tumors

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.

Study Overview

• Status: Recruiting
• Conditions: Renal Tumor
• Intervention / Treatment: Radiation: Stereotactic Ablative Radiotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrew McPartlin, MD; Phone Number: 4855 416-946-4501; Email: andrew.mcpartlin@rmp.uhn.ca

Study Locations

• Canada
  • Ontario
    • Barrie, Ontario, Canada, L4M 6M2
      • Not yet recruiting
      • Royal Victoria Regional Health Centre
    • Toronto, Ontario, Canada, M5G 2M9
      • Recruiting
      • University Health Network - Princess Margaret Cancer Centre
      • Sub-Investigator: Andrew Bayley, MD
      • Contact: Andrew McPartlin, MD; Phone Number: 4855 416-946-4501; Email: andrew.mcpartlin@rmp.uhn.ca
      • Principal Investigator: Andrew McPartlin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stereotactic Ablative Radiotherapy; Adult patients with Kidney mass (either primary or metastasis) amenable to SABR	Radiation: Stereotactic Ablative Radiotherapy; Stereotactic Ablative Radiotherapy to renal tumors with a dose of 27.5-40 Gy in 5 fractions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the radiation induced renal impairments in patients receiving SABR.	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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic Kidney Disease Stage Progression	Chronic kidney disease stage progression after SABR, assessed by the Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines	2 years
2-year Local recurrence rate	2 year local recurrence rate of kidney tumors treated with SABR, measured by assessing the change of irradiated kidney function on functional imaging.	2 years
Patient Reported Outcomes	The change in quality of life of patients treated with SABR, assessed through the use of NCCN FKSI-19 questionnaire.	2 years
Incidence of acute and late toxicities	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.	2 years

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Andrew McPartlin, MD, The Princess Margaret Cancer Foundation

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Anticipated): November 1, 2024
• Study Completion (Anticipated): November 1, 2024

Study Registration Dates

• First Submitted: November 1, 2018
• First Submitted That Met QC Criteria: November 15, 2018
• First Posted (Actual): November 20, 2018

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 7, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Radiation Therapy; Stereotactic Body Radiation Therapy; Renal Cell Carcinoma; RCC; SABR
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Kidney Neoplasms
• Other Study ID Numbers: 18-5481

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No