dc.contributor.author | Nutting, CM | |
dc.contributor.author | Griffin, CL | |
dc.contributor.author | Sanghera, P | |
dc.contributor.author | Foran, B | |
dc.contributor.author | Beasley, M | |
dc.contributor.author | Bernstein, D | |
dc.contributor.author | Cosgrove, V | |
dc.contributor.author | Fisher, S | |
dc.contributor.author | West, CM | |
dc.contributor.author | Sibtain, A | |
dc.contributor.author | Palaniappan, N | |
dc.contributor.author | Urbano, TG | |
dc.contributor.author | Sen, M | |
dc.contributor.author | Soe, W | |
dc.contributor.author | Rizwanullah, M | |
dc.contributor.author | Wood, K | |
dc.contributor.author | Ramkumar, S | |
dc.contributor.author | Junor, E | |
dc.contributor.author | Cook, A | |
dc.contributor.author | Roques, T | |
dc.contributor.author | Scrase, C | |
dc.contributor.author | Bhide, SA | |
dc.contributor.author | Gujral, D | |
dc.contributor.author | Harrington, KJ | |
dc.contributor.author | Mehanna, H | |
dc.contributor.author | Miah, A | |
dc.contributor.author | Emson, M | |
dc.contributor.author | Gardiner, D | |
dc.contributor.author | Morden, JP | |
dc.contributor.author | Hall, E | |
dc.contributor.author | ART DECO Trial Management Group, | |
dc.date.accessioned | 2021-07-12T16:00:26Z | |
dc.date.available | 2021-07-12T16:00:26Z | |
dc.date.issued | 2021-08-01 | |
dc.identifier.citation | European Journal of Cancer, 2021, 153 pp. 242 - 256 | |
dc.identifier.issn | 0959-8049 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/4680 | |
dc.identifier.doi | 10.1016/j.ejca.2021.05.021 | |
dc.description.abstract | BACKGROUND: Radical (chemo)radiotherapy offers potentially curative treatment for patients with locally advanced laryngeal or hypopharyngeal cancer. We aimed to show that dose-escalated intensity-modulated radiotherapy (DE-IMRT) improved locoregional control. METHODS: We performed a phase III open-label randomised controlled trial in patients with laryngeal or hypopharyngeal cancer (AJCC III-IVa/b, TNM 7). Patients were randomised (1:1) to DE-IMRT or standard dose IMRT (ST-IMRT) using a minimisation algorithm, balancing for centre, tumour site, nodal status and chemotherapy use. DE-IMRT was 67.2 gray (Gy) in 28 fractions (f) to the primary tumour and 56Gy/28f to at-risk nodes; ST-IMRT was 65Gy/30f to primary tumour and 54Gy/30f to at-risk nodes. Suitable patients received 2 cycles of concomitant cisplatin and up to 3 cycles of platinum-based induction chemotherapy. The primary end-point was time to locoregional failure analysed by intention-to-treat analysis using competing risk methodology. FINDINGS: Between February 2011 and October 2015, 276 patients (138 ST-IMRT; 138 DE-IMRT) were randomised. A preplanned interim futility analysis met the criterion for early closure. After a median follow-up of 47.9 months (interquartile range 37.5-60.5), there were locoregional failures in 38 of 138 (27.5%) ST-IMRT patients and 42 of 138 (30.4%) DE-IMRT patients; an adjusted subhazard ratio of 1.16 (95% confidence interval: 0.74-1.83, p = 0.519) indicated no evidence of benefit with DE-IMRT. Acute grade 2 pharyngeal mucositis was reported more frequently with DE-IMRT than with ST-IMRT (42% vs. 32%). No differences in grade ≥3 acute or late toxicity rates were seen. CONCLUSION: DE-IMRT did not improve locoregional control in patients with laryngeal or hypopharyngeal cancer. The trial is registered: ISRCTN01483375. | |
dc.format.extent | 242 - 256 | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | ELSEVIER SCI LTD | |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/4.0 | |
dc.title | Dose-escalated intensity-modulated radiotherapy in patients with locally advanced laryngeal and hypopharyngeal cancers: ART DECO, a phase III randomised controlled trial. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2021-05-09 | |
rioxxterms.version | AM | |
rioxxterms.versionofrecord | 10.1016/j.ejca.2021.05.021 | |
rioxxterms.licenseref.uri | https://creativecommons.org/licenses/by-nc-nd/4.0 | |
rioxxterms.type | Journal Article/Review | |
dc.relation.isPartOf | European Journal of Cancer | |
pubs.notes | Not known | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Clinical Trials & Statistics Unit | |
pubs.publication-status | Accepted | |
pubs.volume | 153 | |
pubs.embargo.terms | Not known | |
icr.researchteam | Clinical Trials & Statistics Unit | |
dc.contributor.icrauthor | Griffin, Clare | |
dc.contributor.icrauthor | Bhide, Shreerang | |
dc.contributor.icrauthor | Harrington, Kevin | |
dc.contributor.icrauthor | Emson, Marie | |
dc.contributor.icrauthor | Hall, Emma | |