Oesophageal Cancer Clinical Trial
Official title:
A Randomised Phase II Study of Two Pre-operative Chemoradiotherapy Regimens (Oxaliplatin and Capecitabine Followed by Radiotherapy With Either Oxaliplatin and Capecitabine or Paclitaxel and Carboplatin) for Resectable Oesophageal Cancer
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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