SCOPE1: a randomised phase II/III multicentre clinical trial of definitive
chemoradiation, with or without cetuximab, in carcinoma of the oesophagus.
Author(s): Hurt CN, Nixon LS, Griffiths GO, Al-Mokhtar R, Gollins S, Staffurth JN, Phillips
CJ, Blazeby JM, Crosby TD.
Affiliation(s): Wales Cancer Trials Unit, School of Medicine, Cardiff University, Cardiff, UK.
hurtcn@cardiff.ac.uk
Publication date & source: 2011, BMC Cancer. , 11:466
BACKGROUND: 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.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.
METHODS/DESIGN: 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.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.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. TRIAL REGISTRATION: ISRCTN: ISRCTN47718479.
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