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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.

Competing Interests: Competing interests: None declared.

Titel:	Accelerated, Dose escalated, Sequential Chemoradiotherapy in Non-small-cell lung cancer (ADSCaN): a protocol for a randomised phase II study.
Autor/in / Beteiligte Person:	Hatton, MQF ; Lawless, CA ; Faivre-Finn, C ; Landau, D ; Lester, JF ; Fenwick, J ; Simões, R ; McCartney, E ; Boyd, KA ; Haswell, T ; Shaw, A ; Paul, J
Link:	Full Text Finder (Volltext)
Zeitschrift:	BMJ open, Jg. 9 (2019-01-29), Heft 1, S. e019903
Veröffentlichung:	[London] : BMJ Publishing Group Ltd, 2011-, 2019
Medientyp:	academicJournal
ISSN:	2044-6055 (electronic)
DOI:	10.1136/bmjopen-2017-019903
Schlagwort:	Carcinoma, Non-Small-Cell Lung mortality Carcinoma, Non-Small-Cell Lung pathology Clinical Trials, Phase II as Topic Dose-Response Relationship, Radiation Humans Lung Neoplasms mortality Lung Neoplasms pathology Multicenter Studies as Topic Randomized Controlled Trials as Topic Survival Analysis Treatment Outcome United Kingdom Carcinoma, Non-Small-Cell Lung therapy Chemoradiotherapy methods Dose Fractionation, Radiation Lung Neoplasms therapy
Sonstiges:	Nachgewiesen in: MEDLINE Sprachen: English Publication Type: Clinical Trial Protocol; Journal Article; Research Support, Non-U.S. Gov't Language: English [BMJ Open] 2019 Jan 29; Vol. 9 (1), pp. e019903. <i>Date of Electronic Publication: </i>2019 Jan 29. MeSH Terms: Dose Fractionation, Radiation* ; Carcinoma, Non-Small-Cell Lung / therapy ; Chemoradiotherapy / methods ; Lung Neoplasms / *therapy ; Carcinoma, Non-Small-Cell Lung / mortality ; Carcinoma, Non-Small-Cell Lung / pathology ; Clinical Trials, Phase II as Topic ; Dose-Response Relationship, Radiation ; Humans ; Lung Neoplasms / mortality ; Lung Neoplasms / pathology ; Multicenter Studies as Topic ; Randomized Controlled Trials as Topic ; Survival Analysis ; Treatment Outcome ; United Kingdom References: Clin Oncol (R Coll Radiol). 2009 May;21(4):343-60. (PMID: 19231143) ; J Thorac Oncol. 2018 Mar;13(3):426-435. (PMID: 29326090) ; Int J Radiat Oncol Biol Phys. 2016 Aug 1;95(5):1367-1377. (PMID: 27296040) ; Lancet. 1997 Jul 19;350(9072):161-5. (PMID: 9250182) ; Ann Oncol. 2009 Jan;20(1):98-102. (PMID: 18718891) ; J Clin Oncol. 2010 May 1;28(13):2181-90. (PMID: 20351327) ; J Clin Oncol. 2012 Aug 1;30(22):2788-97. (PMID: 22753901) ; Radiother Oncol. 2016 Mar;118(3):471-7. (PMID: 26687902) ; Lancet Oncol. 2015 Feb;16(2):187-99. (PMID: 25601342) ; J Clin Oncol. 2005 Oct 1;23(28):7199-206. (PMID: 16192604) ; Thorax. 2010 Oct;65 Suppl 3:iii1-27. (PMID: 20940263) ; J Clin Oncol. 2010 Mar 10;28(8):1380-6. (PMID: 20142596) ; Clin Oncol (R Coll Radiol). 2009 Apr;21(3):161-7. (PMID: 19111452) ; Biometrics. 1999 Jun;55(2):580-4. (PMID: 11318217) ; Clin Oncol (R Coll Radiol). 2012 Oct;24(8):e127. (PMID: 22578886) ; J Thorac Oncol. 2014 Nov;9(11):1598-608. (PMID: 25436795) ; BMJ Open. 2016 Apr 15;6(4):e010457. (PMID: 27084277) Grant Information: 16604 United Kingdom CRUK_ Cancer Research UK; A16604 United Kingdom CRUK_ Cancer Research UK Contributed Indexing: Keywords: chemo-radiotherapy; non-small cell lung cancer; radiotherapy; sequential Molecular Sequence: ISRCTN ISRCTN47674500 Entry Date(s): Date Created: 20190201 Date Completed: 20200129 Latest Revision: 20240210 Update Code: 20240210 PubMed Central ID: PMC6352760

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Accelerated, Dose escalated, Sequential Chemoradiotherapy in Non-small-cell lung cancer (ADSCaN): a protocol for a randomised phase II study.