Accelerated, dose escalated, sequential chemoradiotherapy in non-small-cell lung cancer (ADSCaN): a protocol for a randomised phase II study

Hatton, M. Q.F. et al. (2019) Accelerated, dose escalated, sequential chemoradiotherapy in non-small-cell lung cancer (ADSCaN): a protocol for a randomised phase II study. BMJ Open, 9(1), e019903. (doi: 10.1136/bmjopen-2017-019903) (PMID:30700475) (PMCID:PMC6352760)

Abstract

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.

• Item Type: Articles
• Additional Information: This research is funded by Cancer Research UK’s (CRUK) Clinical Trials Awards and Advisory Committee (CTAAC). Grant reference number A16604.
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Paul, Mr James and McCartney, Miss Elaine and Lawless, Miss Claire and Shaw, Ms Ann and Boyd, Professor Kathleen
• Authors: Hatton, M. Q.F., Lawless, C. A., Faivre-Finn, C., Landau, D., Lester, J. F., Fenwick, J., Simoes, R., McCartney, E., Boyd, K., Haswell, T., Shaw, A., and Paul, J.
• College/School: College of Medical Veterinary and Life Sciences > School of Cancer Sciences; College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Health Economics and Health Technology Assessment
• Journal Name: BMJ Open
• Publisher: BMJ Publishing Group
• ISSN: 2044-6055
• ISSN (Online): 2044-6055
• Copyright Holders: Copyright © 2019 The Authors
• First Published: First published in BMJ Open 9(1):e019903
• Publisher Policy: Reproduced under a Creative Commons License