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BMC Cancer
Published in: BMC Cancer 1/2016

Open Access 01-12-2016 | Study protocol

A randomised phase II trial of Stereotactic Ablative Fractionated radiotherapy versus Radiosurgery for Oligometastatic Neoplasia to the lung (TROG 13.01 SAFRON II)

Authors: Shankar Siva, Tomas Kron, Mathias Bressel, Marion Haas, Tao Mai, Shalini Vinod, Giuseppe Sasso, Wenchang Wong, Hien Le, Thomas Eade, Nicholas Hardcastle, Brent Chesson, Daniel Pham, Morten Høyer, Rebecca Montgomery, David Ball

Published in: BMC Cancer | Issue 1/2016

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Abstract

Background

Stereotactic ablative body radiotherapy (SABR) is emerging as a non-invasive method for precision irradiation of lung tumours. However, the ideal dose/fractionation schedule is not yet known. The primary purpose of this study is to assess safety and efficacy profile of single and multi-fraction SABR in the context of pulmonary oligometastases.

Methods/Design

The TROG 13.01/ALTG 13.001 clinical trial is a multicentre unblinded randomised phase II study. Eligible patients have up to three metastases to the lung from any non-haematological malignancy, each < 5 cm in size, non-central targets, and have all primary and extrathoracic disease controlled with local therapies. Patients are randomised 1:1 to a single fraction of 28Gy versus 48Gy in four fractions of SABR. The primary objective is to assess the safety of each treatment arm, with secondary objectives including assessment of quality of life, local efficacy, resource use and costs, overall and disease free survival and time to distant failure. Outcomes will be stratified by number of metastases and origin of the primary disease (colorectal versus non-colorectal primary). Planned substudies include an assessment of the impact of online e-Learning platforms for lung SABR and assessment of the effect of SABR fractionation on the immune responses. A total of 84 patients are required to complete the study.

Discussion

Fractionation schedules have not yet been investigated in a randomised fashion in the setting of oligometastatic disease. Assuming the likelihood of similar clinical efficacy in both arms, the present study design allows for exploration of the hypothesis that cost implications of managing potentially increased toxicities from single fraction SABR will be outweighed by costs associated with delivering multiple-fraction SABR.

Trials registration

ACTRN12613001157​763, registered 17th October 2013
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Metadata
Title
A randomised phase II trial of Stereotactic Ablative Fractionated radiotherapy versus Radiosurgery for Oligometastatic Neoplasia to the lung (TROG 13.01 SAFRON II)
Authors
Shankar Siva
Tomas Kron
Mathias Bressel
Marion Haas
Tao Mai
Shalini Vinod
Giuseppe Sasso
Wenchang Wong
Hien Le
Thomas Eade
Nicholas Hardcastle
Brent Chesson
Daniel Pham
Morten Høyer
Rebecca Montgomery
David Ball
Publication date
01-12-2016
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2016
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/s12885-016-2227-z

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