TROG 15.03 phase II clinical trial of Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney - FASTRACK II 11 Medical and Health Sciences 1103 Clinical Sciences 11 Medical and Health Sciences 1112 Oncology and Carcinogenesis

Siva, S; Chesson, B; Bressel, M; Pryor, D; Higgs, B; Reynolds, HM; Hardcastle, N; Montgomery, R; Vanneste, B; Khoo, V; Ruben, J; Lau, E; Hofman, MS; De Abreu Lourenco, R; Sridharan, S; Brook, NR; Martin, J; Lawrentschuk, N; Kron, T; Foroudi, F

TROG 15.03 phase II clinical trial of Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney - FASTRACK II 11 Medical and Health Sciences 1103 Clinical Sciences 11 Medical and Health Sciences 1112 Oncology and Carcinogenesis

Siva, S Chesson, B Bressel, M Pryor, D Higgs, B Reynolds, HM Hardcastle, N Montgomery, R Vanneste, B Khoo, V Ruben, J Lau, E Hofman, MS De Abreu Lourenco, R

Sridharan, S Brook, NR Martin, J Lawrentschuk, N Kron, T Foroudi, F

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Publication Type:: Journal Article
Citation:: BMC Cancer, 2018, 18 (1)
Issue Date:: 2018-10-23

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Field	Value	Language
dc.contributor.author	Siva, S	en_US
dc.contributor.author	Chesson, B	en_US
dc.contributor.author	Bressel, M	en_US
dc.contributor.author	Pryor, D	en_US
dc.contributor.author	Higgs, B	en_US
dc.contributor.author	Reynolds, HM	en_US
dc.contributor.author	Hardcastle, N	en_US
dc.contributor.author	Montgomery, R	en_US
dc.contributor.author	Vanneste, B	en_US
dc.contributor.author	Khoo, V	en_US
dc.contributor.author	Ruben, J	en_US
dc.contributor.author	Lau, E	en_US
dc.contributor.author	Hofman, MS	en_US
dc.contributor.author	De Abreu Lourenco, R https://orcid.org/0000-0002-5978-8774	en_US
dc.contributor.author	Sridharan, S	en_US
dc.contributor.author	Brook, NR	en_US
dc.contributor.author	Martin, J	en_US
dc.contributor.author	Lawrentschuk, N	en_US
dc.contributor.author	Kron, T	en_US
dc.contributor.author	Foroudi, F	en_US
dc.date.available	2018-10-08	en_US
dc.date.issued	2018-10-23	en_US
dc.identifier.citation	BMC Cancer, 2018, 18 (1)	en_US
dc.identifier.uri	http://hdl.handle.net/10453/134457
dc.description.abstract	© 2018 The Author(s). 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.	en_US
dc.relation.ispartof	BMC Cancer	en_US
dc.relation.isbasedon	10.1186/s12885-018-4916-2	en_US
dc.subject.classification	Oncology & Carcinogenesis	en_US
dc.subject.mesh	Humans	en_US
dc.subject.mesh	Carcinoma, Renal Cell	en_US
dc.subject.mesh	Kidney Neoplasms	en_US
dc.subject.mesh	Treatment Outcome	en_US
dc.subject.mesh	Radiosurgery	en_US
dc.subject.mesh	Adult	en_US
dc.subject.mesh	Multicenter Studies as Topic	en_US
dc.title	TROG 15.03 phase II clinical trial of Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney - FASTRACK II 11 Medical and Health Sciences 1103 Clinical Sciences 11 Medical and Health Sciences 1112 Oncology and Carcinogenesis	en_US
dc.type	Journal Article
utslib.citation.volume	1	en_US
utslib.citation.volume	18	en_US
utslib.for	1112 Oncology and Carcinogenesis	en_US
utslib.for	1117 Public Health and Health Services	en_US
pubs.embargo.period	Not known	en_US
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Business
pubs.organisational-group	/University of Technology Sydney/Strength - CHERE - Centre for Health Economics Research and Evaluation
utslib.copyright.status	open_access
pubs.issue	1	en_US
pubs.publication-status	Published	en_US
pubs.volume	18	en_US

Abstract:

© 2018 The Author(s). 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.

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http://hdl.handle.net/10453/134457