A Feasibility Study of Chemo-radiotherapy to Treat Operable Oesophageal Cancer
NCT01843829
Interventional
Phase 2
Unknown status
NeoSCOPE
About 7500 patients are diagnosed with oesophageal cancer each year in the UK of which less
than a quarter have resectable disease at diagnosis. There is a general lack of consistency
in the standard of care for patients across UK hospitals. Patients are either treated with a)
chemotherapy followed by surgical removal of the tumour, or b) chemoradiotherapy followed by
removal of the tumour by surgery, as part of their standard of care. Recent research supports
the latter treatment, as chemoradiotherapy maybe more effective at shrinking the tumour and
preventing the disease from spreading than taking chemotherapy alone. However, there is no
definitive way of identifying which treatment is best without a clinical trial.
Evidence suggests that the effect of the chemoradiotherapy currently used as standard
practice may be improved and the side effects reduced by using a different chemoradiotherapy
combination. In this trial, eligible patients will receive 2 cycles of the same chemotherapy
before being randomised to receive two different chemoradiotherapy regimens (carboplatin and
paclitaxel verses oxaliplatin and capecitabine) both of which have shown promising results in
previous studies. Patients will then have their tumour removed. The best chemoradiotherapy
regimen will then be taken forward to a Phase III trial in which chemoradiotherapy will be
compared with chemotherapy alone.
The efficacy of the regimens will be measured by counting the number of patients who i)
remain free from cancer, ii)have local or distant spread of their cancer, iii) are
successfully recruited and iv) experience toxicities. A specific set of toxicity criteria
will be used to monitor any treatment induced side-effects and provide justification for any
necessary dose modifications or withdrawal of treatment.
Oct 31,2013
All
18 Years
N/A
18 Years
N/A
85