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

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, 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

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.

Keywords: Ablation; Adrenal; Kidney; Metastases; Nephrectomy; RCC; SABR; SBRT.

Conflict of interest statement

Ethics approval and consent to participate

Ethical approval has been obtained for the clinical sites currently recruiting to this multicentre study at the time of writing;

Princess Alexandra Hospital, Peter MacCallum Cancer Centre, Royal Adelaide Hospital, Royal North Shore Hospital, Alfred Health, Calvary Mater Newcastle.

Royal Brisbane and Women’s Hospital, South Western Sydney Local Health District (Liverpool and Campbelltown Hospitals).

Consent for publication

Not applicable as this protocol publication does not include patient information.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Axial 3D conformal treatment plan of SABR for right kidney (A) and 3D reconstruction (B) showing multiple beam angles resulting in high-doses wrapping tightly around the target

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Source: PubMed

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