TY - JOUR
T1 - Accelerated, Dose escalated, Sequential Chemoradiotherapy in Non-small-cell lung cancer (ADSCaN)
T2 - A protocol for a randomised phase II study
AU - Hatton, Matthew Q.F.
AU - Lawless, Claire Anne
AU - Faivre-Finn, Corinne
AU - Landau, David
AU - Lester, Jason F.
AU - Fenwick, John
AU - Simões, Rita
AU - McCartney, Elaine
AU - Boyd, Kathleen Anne
AU - Haswell, Tom
AU - Shaw, Ann
AU - Paul, James
PY - 2019/1
Y1 - 2019/1
N2 - 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.
AB - 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.
KW - chemo-radiotherapy
KW - non-small cell lung cancer
KW - radiotherapy
KW - sequential
UR - http://www.scopus.com/inward/record.url?scp=85060950350&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2017-019903
DO - 10.1136/bmjopen-2017-019903
M3 - Article
C2 - 30700475
AN - SCOPUS:85060950350
SN - 2044-6055
VL - 9
JO - BMJ Open
JF - BMJ Open
IS - 1
M1 - e019903
ER -