Assessment of QoL and Outcomes With SBRT for RCC (AQuOS-RCC)

December 5, 2023 updated by: William Chu, MD, MSc, FRCPC, Sunnybrook Health Sciences Centre

Assessment of Quality of Life and Outcomes in Patients Treated With Stereotactic Body Radiation Therapy (SBRT) for Primary Renal Cell Carcinoma (RCC) - AQuOS-RCC

Stereotactic body radiotherapy (SBRT) is an emerging radiotherapy technique that precisely delivers high doses of radiation to tumours. It has been investigated as definitive treatment for an increasing variety of primary tumours including lung, liver, prostate, and now renal cell carcinoma (RCC). The principal aims of this study are to prospectively assess quality of life (QoL) and oncologic outcomes in non-surgical patients who receive SBRT for the treatment of RCC.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

There is an evolving body of literature that shows high rates of tumour control and minimal associated toxicities with SBRT to treat RCC. However, the majority of published evidence is retrospective in nature, and there is a scarcity of data on the impact on quality of life and cost-effectiveness of kidney SBRT.

The principal aims of this multicentre study are to prospectively assess QoL and oncologic outcomes in non-surgical patients who receive SBRT for the treatment of primary renal cell carcinoma.

The study population will include 30 consecutive patients treated with kidney SBRT on a conventional linear accelerator (35-40 Gy in 5 fractions) at the Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto (OCC) and the Juravinski Cancer Center, Hamilton Health Sciences Centre, McMaster University (JCC).

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Juravinski Cancer Centre
      • Toronto, Ontario, Canada, M4N 3M5
        • Odette Cancer Centre, Sunnybrook Health Science Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients ≥18 years old
  • Medically inoperable or patient who refuses surgery
  • Histologic diagnosis of RCC where possible, or radiologic evidence of growth on surveillance
  • Lesion ≥2.5cm or recurrent lesion following local ablative therapy
  • Written informed consent
  • Participants must be able to understand the English-language or with the aid of a translator

Exclusion Criteria:

  • ECOG ≥3
  • Prior abdominal radiation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SBRT
RCC patients
Radiation: SBRT
35-40 Gy delivered in 5 fractions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Quality of Life
Time Frame: Up to 5 years after treatment
To evaluate quality of life scores
Up to 5 years after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-Effectiveness
Time Frame: Up to 5 years after completion of treatment
To assess health utility scores and correlate with QoL
Up to 5 years after completion of treatment
Oncologic Outcomes
Time Frame: Up to 5 years after completion of treatment
To evaluate local control
Up to 5 years after completion of treatment
Oncologic Outcomes
Time Frame: Up to 5 years after completion of treatment
To evaluate progression-free survival
Up to 5 years after completion of treatment
Oncologic Outcomes
Time Frame: Up to 5 years after completion of treatment
To evaluate overall survival
Up to 5 years after completion of treatment
Treatment-Related Toxicity
Time Frame: Up to 5 years after completion of treatment
To report number of participants with treatment-related toxicities as assessed by CTCAE v4.0
Up to 5 years after completion of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Collaborators

Juravinski Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

March 19, 2017

First Submitted That Met QC Criteria

April 5, 2017

First Posted (Actual)

April 11, 2017

Study Record Updates

Last Update Posted (Estimated)

December 7, 2023

Last Update Submitted That Met QC Criteria

December 5, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 052-2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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