ALTG 09/005 TROG 09.02 CHISEL: Phase III randomised trial of highly conformal hypfractionated image guided (“stereotactic”) radiotherapy vs conventionally fractionated radiotherapy for inoperable early stage I NSCLC
CHISEL is now closed to accrual. This phase III trial is a TROG study endorsed and co-badged by ALTG. Patients with T1 and T2A N0 non-small cell lung cancer are randomised to hypofractionated stereotactic ablative radiotherapy (either 54 Gy in 3 fractions or 48 Gy in 4 fractions) versus conventionally fractionated radiotherapy 66 Gy in 33 fractions or 50 Gy in 20 fractions. Randomisation is 2 to 1 in favour of the experimental hypofractionated arm. The accrual phase was completed on the 22nd of June 2015, with 101 patients randomised. There are 18 participating sites: Princess Alexandra (29 patients), Peter Mac Moorabbin (10), Peter Mac East Melbourne (27), Alfred (3), Peter Mac Bendigo (2), Peter Mac Box Hill (3), RPAH (0), RNSH (0), Calvary Mater (0), Austin (3), Liverpool (5), Prince of Wales (0), Canberra (4), Royal Adelaide (1), Royal Hobart (2), Christchurch (8), Auckland (3) and Palmerston North (1). The trial is currently in follow-up phase and will be completed in June 2017 (LPLV) with final analysis to follow.
Six serious adverse events have been reported to date including 3 events of exacerbation of COPD, bronchial infection, constipation, and Grade 3 dyspnoea, all of which are thought to be unrelated to the protocol therapy.
This trial has been funded by two grants through Cancer Australia’s Priority-driven Collaborative Cancer Research Scheme.
- Kron T, Clements N, Aarons Y, Dunn L, Chesson B, Miller J, Roozen, K, Ball, D. Radiochromic film for individual patient QA in extracranial stereotactic lung radiotherapy. Radiation 2011;46(12):1920-3.
- Clements N, Kron T, Franich R, Dunn L, Roxby P, Aarons Y, Siva S, Chesson B, Duplan D, Ball D. The effect of irregular breathing patterns on internal target volumes in four dimensional CT and cone-beam CT images in the context of stereotactic lung radiotherapy. Med Phys. 2013;40:021904.
- Siva, S., M. Shaw, B. Chesson, S. Gill and D. Ball (2012). “Analysis of the impact of chest wall constraints on eligibility for a randomized trial of stereotactic body radiotherapy of peripheral stage I non-small cell lung cancer.” J Med Imaging Radiat Oncol 2012; 56(6): 654-660.
Any further enquiries regarding this Trial should be directed to the principal investigator David Ball email@example.com or the central trial manager Janani Sivasuthan firstname.lastname@example.org