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Assessment of QoL and Outcomes With SBRT for RCC

NCT ID: NCT03108703

Last Updated: 2023-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2025-12-31

Brief Summary

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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

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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).

Conditions

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Renal Cell Carcinoma

Keywords

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RCC Stereotactic Body Radiotherapy SBRT Stereotactic Ablative Radiotherapy SABR

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SBRT

RCC patients

Group Type EXPERIMENTAL

SBRT

Intervention Type RADIATION

35-40 Gy delivered in 5 fractions

Interventions

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SBRT

35-40 Gy delivered in 5 fractions

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Juravinski Cancer Center

OTHER

Sponsor Role collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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William Chu, MD, MSc, FRCPC

Radiation Oncologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Juravinski Cancer Centre

Hamilton, Ontario, Canada

Site Status

Odette Cancer Centre, Sunnybrook Health Science Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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052-2015

Identifier Type: -

Identifier Source: org_study_id