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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
85
Patients will have their tumour surgically removed by two-phase oesophagectomy and two-field lymphadenectomy.
Bristol Oncology and Haematology Centre
Bristol, United Kingdom
RECRUITINGValindre NHS
Cardiff, United Kingdom
RECRUITINGUniversity Hospitals Coventry and Warwickshire
Coventry, United Kingdom
RECRUITINGRoyal Derby Hospital
Derby, United Kingdom
NOT_YET_RECRUITINGSt James's Hospital
Leeds, United Kingdom
RECRUITINGLeicester Royal Infirmary
Leicester, United Kingdom
RECRUITINGSt Mary's Hopsital
London, United Kingdom
RECRUITINGThe Christie
Manchester, United Kingdom
RECRUITINGChurchill Hospital
Oxford, United Kingdom
RECRUITINGWeston Park Hospital
Sheffield, United Kingdom
RECRUITING...and 2 more locations
Efficacy
The efficacy of the trial treatment will be assessed by conducting analysis on the resected tumour specimen of participants undergoing surgery. This will be achieved by looking at the pathological complete response rate (pCR).
Time frame: 24 months
Feasibility of recruiting 62 patients within 18 months
Feasibility of recruiting to a pre-operative chemoradiotherapy trial in the UK will be determined by recruitment within 18 months.
Time frame: 18 months
Safety
The trial safety will be assessed by looking at the toxicity. Toxicities during treatment and at 6 and 12 months post-surgery will be recorded using the CTCAE version 4. SAEs will be collected in real time. The morbidity/mortality rate post surgery will also be assessed.
Time frame: 3 years
Efficacy
The efficacy will be measured as a secondary end point by assessing the median, 3 and 5 year overall survival.
Time frame: 5 years
Efficacy
The CRM (circumferential resection margin) which is a measurement of how successful the surgery was in removing all traces of tumour, will be assessed.
Time frame: 24 months
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