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BMC Cancer
Published in: BMC Cancer 1/2018

Open Access 01-12-2018 | Study protocol

TROG 15.03 phase II clinical trial of Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney - FASTRACK II

Authors: Shankar Siva, Brent Chesson, Mathias Bressel, David Pryor, Braden Higgs, Hayley M. Reynolds, Nicholas Hardcastle, Rebecca Montgomery, Ben Vanneste, Vincent Khoo, Jeremy Ruben, Eddie Lau, Michael S. Hofman, Richard De Abreu Lourenco, Swetha Sridharan, Nicholas R. Brook, Jarad Martin, Nathan Lawrentschuk, Tomas Kron, Farshad Foroudi

Published in: BMC Cancer | Issue 1/2018

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Abstract

Background

Stereotactic ablative body radiotherapy (SABR) is a non-invasive alternative to surgery to control primary renal cell cancer (RCC) in patients that are medically inoperable or at high-risk of post-surgical dialysis. The objective of the FASTRACK II clinical trial is to investigate the efficacy of SABR for primary RCC.

Methods

FASTRACK II is a single arm, multi-institutional phase II study. Seventy patients will be recruited over 3 years and followed for a total of 5 years. Eligible patients must have a biopsy confirmed diagnosis of primary RCC with a single lesion within a kidney, have ECOG performance ≤2 and be medically inoperable, high risk or decline surgery. Radiotherapy treatment planning is undertaken using four dimensional CT scanning to incorporate the impact of respiratory motion. Treatment must be delivered using a conformal or intensity modulated technique including IMRT, VMAT, Cyberknife or Tomotherapy. The trial includes two alternate fractionation schedules based on tumour size: for tumours ≤4 cm in maximum diameter a single fraction of 26Gy is delivered; and for tumours > 4 cm in maximum diameter 42Gy in three fractions is delivered. The primary outcome of the study is to estimate the efficacy of SABR for primary RCC. Secondary objectives include estimating tolerability, characterising overall survival and cancer specific survival, estimating the distant failure rate, describing toxicity and renal function changes after SABR, and assessment of cost-effectiveness of SABR compared with current therapies.

Discussion

The present study design allows for multicentre prospective validation of the efficacy of SABR for primary RCC that has been observed from prior single institutional and retrospective series. The study also allows assessment of treatment related toxicity, overall survival, cancer specific survival, freedom from distant failure and renal function post therapy.

Trial registration

Clinicaltrials.​gov NCT02613819, registered Nov 25th 2015.
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Metadata
Title
TROG 15.03 phase II clinical trial of Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney - FASTRACK II
Authors
Shankar Siva
Brent Chesson
Mathias Bressel
David Pryor
Braden Higgs
Hayley M. Reynolds
Nicholas Hardcastle
Rebecca Montgomery
Ben Vanneste
Vincent Khoo
Jeremy Ruben
Eddie Lau
Michael S. Hofman
Richard De Abreu Lourenco
Swetha Sridharan
Nicholas R. Brook
Jarad Martin
Nathan Lawrentschuk
Tomas Kron
Farshad Foroudi
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2018
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/s12885-018-4916-2

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