EPOC B

• Research type

  Research Study

• Full title

  An exploratory study to investigate the optimal scheduling of chemotherapy in patients with operable colorectal liver metastases

• IRAS ID

  80339

• Sponsor organisation

  University Hospital Southampton NHS Foundation Trust

• Eudract number

  2011-003052-40

• ISRCTN Number

  n/a

• Research summary

  This is a multicentre randomised control trial in patients who have operable liver metastases from colorectal cancer as determined by the regional hepatobiliary multidisciplinary team.Patients will receive either 24 weeks of standard chemotherapy treatment (either mFOLFOX, mFOLFIRI or CAPOX) after surgery or 12 weeks before and 12 weeks after surgery. After completion of study treatment patients will be followed up every 3 months for 2 years, and every 6 months thereafter for a further 3 years or until progression of disease. The primary aim of this study aims is to determine whether it is feasible to recruit patients to such a trial. In addition we will compare the proportion of chemotherapy, the side effects following surgery and chemotherapy, the quality of life and the survival between the 2 arms. This will tell us whether it is possible to conduct a larger study to determine which strategy is better for patients.Eligible patients are those with confirmed colorectal adenocarcinoma, resectable colorectal cancer liver metastases (without metastases beyond the liver that cannot be completely resected), 18 years of age or older, fit for chemotherapy and surgery, adequate blood tests and no prior chemotherapy for metastatic disease.78 Patients will be recruited from sites in the UK.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  11/SC/0293

• Date of REC Opinion

  7 Sep 2011

• REC opinion

  Further Information Favourable Opinion