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

Primary Purpose

Renal Cell Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
SBRT
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring RCC, Stereotactic Body Radiotherapy, SBRT, Stereotactic Ablative Radiotherapy, SABR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Juravinski Cancer Centre
  • Odette Cancer Centre, Sunnybrook Health Science Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SBRT

Arm Description

RCC patients

Outcomes

Primary Outcome Measures

Patient Quality of Life
To evaluate quality of life scores

Secondary Outcome Measures

Cost-Effectiveness
To assess health utility scores and correlate with QoL
Oncologic Outcomes
To evaluate local control
Oncologic Outcomes
To evaluate progression-free survival
Oncologic Outcomes
To evaluate overall survival
Treatment-Related Toxicity
To report number of participants with treatment-related toxicities as assessed by CTCAE v4.0

Full Information

First Posted
March 19, 2017
Last Updated
December 15, 2020
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Juravinski Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03108703
Brief Title
Assessment of QoL and Outcomes With SBRT for RCC
Acronym
AQuOS-RCC
Official Title
Assessment of Quality of Life and Outcomes in Patients Treated With Stereotactic Body Radiation Therapy (SBRT) for Primary Renal Cell Carcinoma (RCC) - AQuOS-RCC
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Juravinski Cancer Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
RCC, Stereotactic Body Radiotherapy, SBRT, Stereotactic Ablative Radiotherapy, SABR

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SBRT
Arm Type
Experimental
Arm Description
RCC patients
Intervention Type
Radiation
Intervention Name(s)
SBRT
Intervention Description
35-40 Gy delivered in 5 fractions
Primary Outcome Measure Information:
Title
Patient Quality of Life
Description
To evaluate quality of life scores
Time Frame
Up to 5 years after treatment
Secondary Outcome Measure Information:
Title
Cost-Effectiveness
Description
To assess health utility scores and correlate with QoL
Time Frame
Up to 5 years after completion of treatment
Title
Oncologic Outcomes
Description
To evaluate local control
Time Frame
Up to 5 years after completion of treatment
Title
Oncologic Outcomes
Description
To evaluate progression-free survival
Time Frame
Up to 5 years after completion of treatment
Title
Oncologic Outcomes
Description
To evaluate overall survival
Time Frame
Up to 5 years after completion of treatment
Title
Treatment-Related Toxicity
Description
To report number of participants with treatment-related toxicities as assessed by CTCAE v4.0
Time Frame
Up to 5 years after completion of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Odette Cancer Centre, Sunnybrook Health Science Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Assessment of QoL and Outcomes With SBRT for RCC

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