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

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ClinicalTrials.gov Identifier: NCT03108703
Recruitment Status : Recruiting
First Posted : April 11, 2017
Last Update Posted : April 11, 2017
Sponsor:
Collaborator:
Dr. Anand Swaminanth (Co-Principal Investigator), Juravinski Cancer Centre
Information provided by (Responsible Party):
Dr. William Chu, Sunnybrook Health Sciences Centre

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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Radiation: SBRT Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2015
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Quality of Life [ Time Frame: Up to 5 years after treatment ]
    To evaluate quality of life scores


Secondary Outcome Measures :
  1. Cost-Effectiveness [ Time Frame: Up to 5 years after completion of treatment ]
    To assess health utility scores and correlate with QoL

  2. Oncologic Outcomes [ Time Frame: Up to 5 years after completion of treatment ]
    To evaluate local control

  3. Oncologic Outcomes [ Time Frame: Up to 5 years after completion of treatment ]
    To evaluate progression-free survival

  4. Oncologic Outcomes [ Time Frame: Up to 5 years after completion of treatment ]
    To evaluate overall survival

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03108703


Contacts
Contact: William Chu, MD 416-480-6100 ext 7086 william.chu@sunnybrook.ca
Contact: Darby Erler, MHSc 416-480-6100 ext 7844 darby.erler@sunnybrook.ca

Locations
Canada, Ontario
Juravinski Cancer Centre Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Anand Swaminath, MD    905-387-9711 ext 63123    swaminath@hhsc.ca   
Odette Cancer Centre, Sunnybrook Health Science Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: William Chu, MD    416-480-6100 ext 7086    william.chu@sunnybrook.ca   
Contact: Darby Erler, MHSx    416-480-6100 ext 7844    darby.erler@sunnybrook.ca   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Dr. Anand Swaminanth (Co-Principal Investigator), Juravinski Cancer Centre

Responsible Party: Dr. William Chu, Radiation Oncologist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT03108703     History of Changes
Other Study ID Numbers: 052-2015
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dr. William Chu, Sunnybrook Health Sciences Centre:
RCC
Stereotactic Body Radiotherapy
SBRT
Stereotactic Ablative Radiotherapy
SABR

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases