Randomised trial testing dose escalated, intensity-modulated radiotherapy for women treated by breast conservation surgery and appropriate systemic therapy for early breast cancer
Disease site: Breast cancer
Treatment modality: Radiotherapy
Status: In follow up
Protocol and planning packs
IMPORT HIGH is a phase III, prospective, randomised controlled trial to test whether dose escalated, intensity-modulated radiotherapy after conservation surgery for early breast cancer could reduce radiotherapy side effects, whilst maintaining or increasing cancer cure, in women with higher than average local recurrence risk.
IMPORT HIGH closed to recruitment in September 2015 after recruiting 2,621 patients from UK hospitals. Participants were randomised to one of three groups. Those allocated to either of the two treatment arms received varying doses of radiotherapy across the breast with a concomitant boost dose to the tumour bed, while patients in the control arm received standard radiotherapy. Participants are now being followed up for a further 10 years.
Chief Investigator: Dr Charlotte Coles, University of Cambridge
ICR-CTSU Scientific Lead: Professor Judith Bliss
Trial management contact: [email protected]
Sponsor: The Institute of Cancer Research
Funding: Cancer Research UK (CRUK/06/003) and the Department of Health
Further information including recruitment progress is available from the UK Clinical Trials Gateway.
A plain English summary is available from Cancer Research UK.
Publications and presentations
Y Tsang, L Ciurlionis, A Kirby, I Locke, J Yarnold, J Titley, J Bliss, C Coles and on behalf of the IMPORT trial management group Clinical Impact of IMPORT HIGH trial (CRUK/06/003) on breast radiotherapy practices in the United Kingdom. Br J Radiol 2015; 88: 20150453
Harris E, Mukesh M, Jena R, Baker A, Bartelink H, Brooks C, Dean J, Donovan E, Collette S, Eagle S, Fenwick J, Graham P, Haviland J, Kirby A, Mayles H. A multicentre observational study evaluating image-guided radiotherapy for more accurate partial-breast intensity-modulated radiotherapy: comparison with standard imaging technique. Efficacy Mech Eval. 2014; 1(3).
Tsang Y, Ciurlionis L, Kirby A, Venables K, Yarnold J, Coles C. Clinical impact of IMPORT HIGH trial (CRUK/06/003) on breast radiotherapy in the United Kingdom. Poster presented at: ESTRO 33; 2014 April 4-8; Vienna, Austria.
Donovan EM, Ciurlionis L, Fairfoul J, James H, Mayles H, Manktelow S, Raj S, Tsang Y, Tywman N, Yarnold J, Coles C. Planning with IMRT and tomotherapy to modulate dose across the breast to reflect recurrence risk (the IMPORT HIGH trial). Int J Radiat Oncol Biol Phys. 2011; 79(4): 1064-72.
Cole CE, Harris EJ, Donovan EM, Bliss P, Evans PM, Fairfoul J, Mackenzie C, Rawlings C, Syndikus I, Twyman N, Vasconcelos J, Vowler SL, Wilkinson JS, Wilks R, Wishart GC, Yarnold J. Evaluation of implanted gold seeds for breast radiotherapy planning and on treatment verification: a feasibility study on behalf of the IMPORT trialists. Radiother Oncol. 2011; 100: 276-81.
J Titley, C Ciurlionis, Y Tsang, K Venables, G Sumo, C Coles, J Yarnold, J Bliss; on behalf of the IMPORT Trial Management Group. Implementation of new radiotherapy delivery techniques on a national scale – the IMPORT HIGH trial. Poster presented at: 6th National Cancer Research Institute Cancer Conference; 2010 Nov 7-10; Liverpool, UK: #B121.
Harris EJ, Donovan EM, Yarnold JR, Coles CE, Evans PM; on behalf of the IMPORT Trial Management Group. Characterisation of target volume changes during breast radiotherapy using implanted fiducial markers and portal imaging. Int J Radiat Oncol Biol Phys. 2009; 73(3): 958-66.
Tsang Y, Coles C, Donovan E, Bliss J, Ciurlionis L, Haviland J, Titley J, Yarnold J; IMPORT Trial Management Group. IMPORT HIGH: development of comprehensive and practical radiotherapy planning solutions to facilitate trial recruitment. Poster session presented at: 5th National Cancer Research Institute Cancer Conference; 2009 Oct 4-7; Birmingham, UK.
Titley J, Bliss J, Coles C, Donovan E, Evans P, Haviland J, Sydenham M, Yarnold J; IMPORT Trial Management Group. IMPORT HIGH: introduction of image guided breast radiotherapy via a national breast trial. Poster session presented at: 4th National Cancer Research Institute Cancer Conference; 2008 Oct 5-8; Birmingham, UK.
Conway L, Tsang Y; on behalf of the IMPORT Trial Management Group. A forward-planning solution for the IMPORT HIGH breast IMRT trial. Clin Oncol (R Coll Radiol). 2007; 19(3): S15.
Coles CE, Wishart G, Donovan E, Harris E, Poynter A, Twyman N, Routsis D, Wilkinson J, Yarnold J; on behalf of the IMPORT Working Party. The IMPORT Gold Seed Study: evaluation of tumour bed localisation and image-guided radiotherapy for breast cancer. Clin Oncol (R Coll Radiol). 2007; 19(3): S26–S27.