EORTC 40091/ BOS-2

• Research type

  Research Study

• Full title

  Randomized phase II trial evaluating the efficacy of FOLFOX alone, FOLFOX plus bevacizumab and FOLFOX plus panitumumab as perioperative treatment in patients with resectable liver metastases from wild type KRAS and NRAS colorectal cancer

• IRAS ID

  118499

• Contact name

  Robert Glynne-Jones

• Contact email

  Rob.glynnejones@nhs.net

• Sponsor organisation

  European Organisation for Research and Treatment of Cancer

• Eudract number

  2010-019238-29

• Clinicaltrials.gov Identifier

  NCT01508000

• Research summary

  The aim of the trial is to detect an increase in progression free survival rate at 1 year in each experimental arm (standard treatment, which is mFOLFOX6 + the study drugs, either bevacizumab or panitumumab) compared to mFOLFOX6 alone arm as perioperative treatment for liver metastasis that can be surgically removed from a specific type of cancer [wild type Kirsten rat sarcoma viral oncogene homolog (KRAS) colorectal cancer(CRC)] that originates in the rectum or the colon.
  For patients who can participate in the trial the treating doctor considers it possible to safely remove the liver cancer that originated from the tumour in the colon or rectum. Complete surgical removal of all the parts of the liver affected by the tumour represents the best currently available treatment to be offered to patients with this type of cancer. Despite complete surgical removal, the disease may recur after surgery. Therefore, it is worthwhile to try and identify a better treatment approach to reduce the risk of recurrence. Administration of drugs before or after surgery may decrease the chances of recurrence.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  13/LO/1797

• Date of REC Opinion

  24 Feb 2014

• REC opinion

  Further Information Favourable Opinion