NeoSCOPE: Neo-adjuvant Study of Chemoradiotherapy in OesoPhagEal Cance

• Research type

  Research Study

• Full title

  A randomised Phase II study of two pre-operative chemoradiotherapy regimes (oxaliplatin and capecitabine followed by radiotherapy with either oxaliplatin and capecitabine or paclitaxel and carboplatin) for resectable oesophageal cancer.

• IRAS ID

  96426

• Contact name

  Tom Crosby

• Sponsor organisation

  Velindre NHS Trust

• Eudract number

  2012-000640-10

• ISRCTN Number

  to be registered

• Research summary

  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)chemo-radiotherapy followed by surgical removal of the tumour, as part of their standard of care. Recent research supports the latter treatment regimen, as chemo-radiotherapy 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 chemo-radiotherapy currently used as standard practice may be improved and the side effects reduced by using a different chemo-radiotherapy combination. In this trial, eligible patients will receive 2 cycles of the same chemotherapy before being randomised to receive two different chemo-radiotherapy 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 chemo-radiotherapy regimen will then be taken forward to a Phase III trial in which chemo-radiotherapy 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 recurrence/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.

• REC name

  Wales REC 2

• REC reference

  12/WA/0345

• Date of REC Opinion

  26 Nov 2012

• REC opinion

  Favourable Opinion