SCOPE1: a randomised phase II/III multicentre clinical trial of definitive chemoradiation, with or without cetuximab, in carcinoma of the oesophagus

<p>Abstract</p> <p>Background</p> <p>Chemoradiotherapy is the standard of care for patients with oesophageal cancer unsuitable for surgery due to the presence of co-morbidity or extent of disease, and is a standard treatment option for patients with squamous cell carcin...

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Main Authors: Staffurth John N, Gollins Simon, Al-Mokhtar Ruby, Griffiths Gareth O, Nixon Lisette S, Hurt Christopher N, Phillips Ceri J, Blazeby Jane M, Crosby Tom D
Format: Article
Language:English
Published: BMC 2011-10-01
Series:BMC Cancer
Online Access:http://www.biomedcentral.com/1471-2407/11/466
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spelling doaj-0dd6a66f021f43ab8f0f2134aae8701f2020-11-25T01:49:16ZengBMCBMC Cancer1471-24072011-10-0111146610.1186/1471-2407-11-466SCOPE1: a randomised phase II/III multicentre clinical trial of definitive chemoradiation, with or without cetuximab, in carcinoma of the oesophagusStaffurth John NGollins SimonAl-Mokhtar RubyGriffiths Gareth ONixon Lisette SHurt Christopher NPhillips Ceri JBlazeby Jane MCrosby Tom D<p>Abstract</p> <p>Background</p> <p>Chemoradiotherapy is the standard of care for patients with oesophageal cancer unsuitable for surgery due to the presence of co-morbidity or extent of disease, and is a standard treatment option for patients with squamous cell carcinoma of the oesophagus. Modern regimens of chemoradiotherapy can lead to significant long-term survival. However the majority of patients will die of their disease, most commonly with local progression/recurrence of their tumours. Cetuximab may overcome one of the principal mechanisms of tumour radio-resistance, namely tumour repopulation, in patients treated with chemoradiotherapy.</p> <p>The purpose of this research is first to determine whether the addition of cetuximab to definitive chemoradiotherapy for treatment of patients with non-metastatic carcinoma of the oesophagus is active (in terms of failure-free rate), safe, and feasible within the context of a multi-centre randomised controlled trial in the UK. If the first stage is successful then the trial will continue to accrue sufficient patients to establish whether the addition of cetuximab to the standard treatment improves overall survival.</p> <p>Methods/Design</p> <p>SCOPE1 is a two arm, open, randomised multicentre Phase II/III trial. Eligible patients will have histologically confirmed carcinoma of the oesophagus and have been chosen to receive definitive chemoradiotherapy by an accredited multidisciplinary team including a specialist Upper GI surgeon. 420 patients will be randomised to receive definitive chemoradiotherapy with or without cetuximab using a 1:1 allocation ratio.</p> <p>During Phase II of the study, the trial will assess safety (toxicity), activity (failure-free rate) and feasibility (recruitment rate and protocol dose modifications/delays) in 90 patients in the experimental arm. If the experimental arm is found to be active, safe, and feasible by the Independent Data Monitoring Committee then recruitment will continue into Phase III. This second stage will recruit a further 120 patients into each arm and compare the overall survival of both groups.</p> <p>All patients randomised into Phase II will contribute to the Phase III comparison of overall survival. In addition to overall survival, Phase III of the study will also assess toxicity, health related quality of life and cost effectiveness. A detailed radiotherapy protocol and quality assurance procedure has been incorporated into this trial.</p> <p>Trial registration</p> <p>ISRCTN: <a href="http://www.controlled-trials.com/ISRCTN47718479">ISRCTN47718479</a></p> http://www.biomedcentral.com/1471-2407/11/466
collection DOAJ
language English
format Article
sources DOAJ
author Staffurth John N
Gollins Simon
Al-Mokhtar Ruby
Griffiths Gareth O
Nixon Lisette S
Hurt Christopher N
Phillips Ceri J
Blazeby Jane M
Crosby Tom D
spellingShingle Staffurth John N
Gollins Simon
Al-Mokhtar Ruby
Griffiths Gareth O
Nixon Lisette S
Hurt Christopher N
Phillips Ceri J
Blazeby Jane M
Crosby Tom D
SCOPE1: a randomised phase II/III multicentre clinical trial of definitive chemoradiation, with or without cetuximab, in carcinoma of the oesophagus
BMC Cancer
author_facet Staffurth John N
Gollins Simon
Al-Mokhtar Ruby
Griffiths Gareth O
Nixon Lisette S
Hurt Christopher N
Phillips Ceri J
Blazeby Jane M
Crosby Tom D
author_sort Staffurth John N
title SCOPE1: a randomised phase II/III multicentre clinical trial of definitive chemoradiation, with or without cetuximab, in carcinoma of the oesophagus
title_short SCOPE1: a randomised phase II/III multicentre clinical trial of definitive chemoradiation, with or without cetuximab, in carcinoma of the oesophagus
title_full SCOPE1: a randomised phase II/III multicentre clinical trial of definitive chemoradiation, with or without cetuximab, in carcinoma of the oesophagus
title_fullStr SCOPE1: a randomised phase II/III multicentre clinical trial of definitive chemoradiation, with or without cetuximab, in carcinoma of the oesophagus
title_full_unstemmed SCOPE1: a randomised phase II/III multicentre clinical trial of definitive chemoradiation, with or without cetuximab, in carcinoma of the oesophagus
title_sort scope1: a randomised phase ii/iii multicentre clinical trial of definitive chemoradiation, with or without cetuximab, in carcinoma of the oesophagus
publisher BMC
series BMC Cancer
issn 1471-2407
publishDate 2011-10-01
description <p>Abstract</p> <p>Background</p> <p>Chemoradiotherapy is the standard of care for patients with oesophageal cancer unsuitable for surgery due to the presence of co-morbidity or extent of disease, and is a standard treatment option for patients with squamous cell carcinoma of the oesophagus. Modern regimens of chemoradiotherapy can lead to significant long-term survival. However the majority of patients will die of their disease, most commonly with local progression/recurrence of their tumours. Cetuximab may overcome one of the principal mechanisms of tumour radio-resistance, namely tumour repopulation, in patients treated with chemoradiotherapy.</p> <p>The purpose of this research is first to determine whether the addition of cetuximab to definitive chemoradiotherapy for treatment of patients with non-metastatic carcinoma of the oesophagus is active (in terms of failure-free rate), safe, and feasible within the context of a multi-centre randomised controlled trial in the UK. If the first stage is successful then the trial will continue to accrue sufficient patients to establish whether the addition of cetuximab to the standard treatment improves overall survival.</p> <p>Methods/Design</p> <p>SCOPE1 is a two arm, open, randomised multicentre Phase II/III trial. Eligible patients will have histologically confirmed carcinoma of the oesophagus and have been chosen to receive definitive chemoradiotherapy by an accredited multidisciplinary team including a specialist Upper GI surgeon. 420 patients will be randomised to receive definitive chemoradiotherapy with or without cetuximab using a 1:1 allocation ratio.</p> <p>During Phase II of the study, the trial will assess safety (toxicity), activity (failure-free rate) and feasibility (recruitment rate and protocol dose modifications/delays) in 90 patients in the experimental arm. If the experimental arm is found to be active, safe, and feasible by the Independent Data Monitoring Committee then recruitment will continue into Phase III. This second stage will recruit a further 120 patients into each arm and compare the overall survival of both groups.</p> <p>All patients randomised into Phase II will contribute to the Phase III comparison of overall survival. In addition to overall survival, Phase III of the study will also assess toxicity, health related quality of life and cost effectiveness. A detailed radiotherapy protocol and quality assurance procedure has been incorporated into this trial.</p> <p>Trial registration</p> <p>ISRCTN: <a href="http://www.controlled-trials.com/ISRCTN47718479">ISRCTN47718479</a></p>
url http://www.biomedcentral.com/1471-2407/11/466
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