ADSCaN: A Randomised Phase II study of Accelerated, Dose escalated, Sequential Chemo-radiotherapy in Non-Small Cell Lung Cancer (NSCLC)


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Claire Lawless1,Kathleen Boyd2,Corinne Faivre-Finn3,John Fenwick4,Tom Haswell5,David Landau6,Jason Lester7,Joe Maguire8,Elaine McCartney1,Jim Paul1,Matthew Hatton9

1CRUK Clinical Trials Unit, Beatson West of Scotland Cancer Centre, Glasgow, UK,2Health Economics & Health Technology Assessment, University of Glasgow, Glasgow, UK,3The Christie NHS Foundation Trust, Manchester, UK,4Gray Institute of Radiation Oncology & Biology, University of Oxford, Oxford, UK,5West of Scotland Cancer Research Consumer Panel, Glasgow, UK,6Guys & St Thomas NHS Trust, London, UK,7Velindre Cancer Centre, Cardiff, UK,8Clatterbridge Cancer Centre, Liverpool, UK,9Weston Park Hospital, Sheffield, UK

Abstract

Background

Lung cancer is the most common cause of cancer mortality in the UK, and 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 gold standard treatment (concurrent chemo-radiotherapy) due to performance status and comorbidities. Novel strategies integrating radiotherapy advances and radiobiological knowledge need to be evaluated in patients treated with sequential chemo-radiotherapy. Four separate accelerated dose escalated radiotherapy schedules have been completed in UK (CHART-ED{1}, IDEAL-CRT{2}, I-START{3} and Isotoxic IMRT{4}). ADSCaN will compare these schedules with a UK standard sequential chemo-radiotherapy schedule. A combined randomized phase II screening / ‘pick the winner’ approach will identify the best schedule to take into a randomised phase III study against conventionally fractionated radiotherapy.

Method

Suitable patients will have histologically / cytologically confirmed, stage III NSCLC and be able to undergo chemo-radiotherapy treatment. The study will recruit 360 patients; 130 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.

 

Logistic / capacity challenges make it impractical for sites to open all experimental trial arms; a novel trial design allows centres to select upfront the experimental arms they are able to participate in and all will offer the standard arm.

Results

Funding has been awarded by CRUK for this multicentre study which is being co-ordinated by the CRUK CTU Glasgow and includes a robust quality assurance programme led by the National RTTQA group.

Conclusion

The study opened to recruitment on 22/08/2017. 19/36 sites are currently activated to recruitment. 43 patients have been randomised on study to date.

 

 

Background

Lung cancer is the most common cause of cancer mortality in the UK, and 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 chemo-radiotherapy) due to performance status and comorbidities. Consequently novel strategies integrating radiotherapy advances and radiobiological knowledge need to be evaluated in patients treated with sequential chemo-radiotherapy. The UK strategy has been to develop separate dose escalation protocols for accelerated radiotherapy schedules (CHART-ED {1}, IDEAL-CRT {2}, I-START {3} and Isotoxic IMRT {4}).  This study will compare these schedules with a UK standard sequential chemo-radiotherapy schedule of 55Gy in 20 fractions over 4 weeks.  As it would be impossible to test all schedules in phase III study, the aim is to use a combined randomized phase II screening / ‘pick the winner’  approach to identify the best schedule to take into a randomised Phase III study against conventionally fractionated radiotherapy.

Method

Suitable patients will have histologically / cytologically confirmed, stage III NSCLC and are able to undergo chemo-radiotherapy treatment.  The study will recruit 390 patients; 130 patients on the standard arm and 65 on each experimental arm.  Patients will complete 3 cycles of a platinum based chemotherapy before being randomised on study to one of the radiotherapy schedules.

 

Results

Funding has been awarded by CRUK for this multicentre study which is being co-ordinated by the CRUK CTU Glasgow and includes a robust quality assurance programme led by the NRCI RTTQA group.

 

Conclusion

The study is in set up, with an anticipated start date of January 2016. Recruitment will last 3 years 8 months and subsequent follow-up of 12 months is required.   40-50 UK cancer centres will participate in this study.