Accelerated, dose escalated, sequential chemoradiotherapy in non-small-cell lung cancer (ADSCaN): a protocol for a randomised phase II study.
Authors
Hatton, MLawless, C
Faivre-Finn, Corinne
Landau, D
Lester, J
Fenwick, J
Simoes, R
McCartney, E
Boyd, K
Haswell, T
Shaw, A
Paul, J
Affiliation
Department of Clinical Oncology, Weston Park Hospital, Sheffield, UKIssue Date
2019
Metadata
Show full item recordAbstract
INTRODUCTION: Lung cancer is the most common cause of cancer mortality in the UK, and non-small-cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancers. Most patients present with inoperable disease; therefore, radiotherapy plays a major role in treatment. However, the majority of patients are not suitable for the gold standard treatment (concurrent chemoradiotherapy) due to performance status and comorbidities. Novel strategies integrating radiotherapy advances and radiobiological knowledge need to be evaluated in patients treated with sequential chemoradiotherapy. Four separate dose escalation accelerated radiotherapy schedules have been completed in UK (CHART-ED, IDEAL-CRT, I-START and Isotoxic IMRT). This study will compare these schedules with a UK standard sequential chemoradiotherapy schedule of 55 Gy in 20 fractions over 4 weeks. As it would be impossible to test all schedules in a phase III study, the aim is to use a combined randomised phase II screening/'pick the winner' approach to identify the best schedule to take into a randomised phase III study against conventionally fractionated radiotherapy. METHODS AND ANALYSIS: Suitable patients will have histologically/cytologically confirmed, stage III NSCLC and are able to undergo chemoradiotherapy treatment. The study will recruit 360 patients; 120 on the standard arm and 60 on each experimental arm. Patients will complete 2-4 cycles of platinum-based chemotherapy before being randomised to one of the radiotherapy schedules. The primary endpoint is progression-free survival, with overall survival, time to local-regional failure, toxicity and cost-effectiveness as secondary objectives. ETHICS AND DISSEMINATION: The study has received ethical approval (research ethics committee (REC) reference: 16/WS/0165) from the West of Scotland REC 1. The trial is conducted in accordance with the Declaration of Helsinki and Good Clinical Practice. Trial results will be published in a peer-reviewed journal and presented internationally. TRIAL REGISTRATION NUMBER: ISRCTN47674500.Citation
Hatton MQF, Lawless CA, Faivre-Finn C, Landau D, Lester JF, Fenwick J, et al. Accelerated, dose escalated, sequential chemoradiotherapy in non-small-cell lung cancer (ADSCaN): a protocol for a randomised phase II study. BMJ Open. 2019 Jan 29;9(1):e019903.Journal
BMJ OpenDOI
10.1136/bmjopen-2017-019903PubMed ID
30700475Additional Links
https://dx.doi.org/10.1136/bmjopen-2017-019903Type
ArticleLanguage
enae974a485f413a2113503eed53cd6c53
10.1136/bmjopen-2017-019903
Scopus Count
Collections
Related articles
- Protocol for the isotoxic intensity modulated radiotherapy (IMRT) in stage III non-small cell lung cancer (NSCLC): a feasibility study.
- Authors: Haslett K, Franks K, Hanna GG, Harden S, Hatton M, Harrow S, McDonald F, Ashcroft L, Falk S, Groom N, Harris C, McCloskey P, Whitehurst P, Bayman N, Faivre-Finn C
- Issue date: 2016 Apr 15
- Protocol for the CONVERT trial-Concurrent ONce-daily VErsus twice-daily RadioTherapy: an international 2-arm randomised controlled trial of concurrent chemoradiotherapy comparing twice-daily and once-daily radiotherapy schedules in patients with limited stage small cell lung cancer (LS-SCLC) and good performance status.
- Authors: Faivre-Finn C, Falk S, Ashcroft L, Bewley M, Lorigan P, Wilson E, Groom N, Snee M, Fournel P, Cardenal F, Bezjak A, Blackhall F
- Issue date: 2016 Jan 20
- SOCCAR: A randomised phase II trial comparing sequential versus concurrent chemotherapy and radical hypofractionated radiotherapy in patients with inoperable stage III Non-Small Cell Lung Cancer and good performance status.
- Authors: Maguire J, Khan I, McMenemin R, O'Rourke N, McNee S, Kelly V, Peedell C, Snee M
- Issue date: 2014 Nov
- Continuous hyperfractionated accelerated radiotherapy - Escalated dose (CHART-ED): A phase I study.
- Authors: Hatton MQ, Hill R, Fenwick JD, Morgan SA, Wilson PC, Atherton PJ, Dickson J, Murray KE, Paul J
- Issue date: 2016 Mar
- Primary lung tumour stereotactic body radiotherapy followed by concurrent mediastinal chemoradiotherapy and adjuvant immunotherapy for locally advanced non-small-cell lung cancer: a multicentre, single-arm, phase 2 trial.
- Authors: Heinzerling JH, Mileham KF, Robinson MM, Symanowski JT, Induru RR, Brouse GM, Corso CD, Prabhu RS, Haggstrom DE, Moeller BJ, Bobo WE, Fasola CE, Thakkar VV, Pal SE, Gregory JM, Norek SL, Begic XJ, Kesarwala AH, Burri SH, Simone CB 2nd
- Issue date: 2025 Jan