PERU Version 8.0

• Research type

  Research Study

• Full title

  A multicentre randomised phase II clinical study of UFT/leucovorin radiotherapy with or without cetuximab following induction gemcitabine plus capecitabine in patients with locally advanced pancreatic cancer

• IRAS ID

  13843

• Sponsor organisation

  The Royal Marsden Hospital NHS Trust London and Surrey

• Eudract number

  2008-000517-30

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The purpose of this study is to find out whether patients with advanced pancreatic cancer that is inoperable, but has not spread to other organs (locally advanced), benefit from the drugs UFT/leucovorin (LV) and cetuximab being added to their radiotherapy treatment.The standard treatment for patients with locally advanced pancreatic cancer is chemotherapy with gemcitabine alone, or gemcitabine plus capecitabine.. At some centres, patients that benefit from their chemotherapy (if a CT scan shows that the disease has stopped growing or reduced in size whilst on the chemotherapy) will go on to receive radiotherapy aiming to maintain the benefit of the chemotherapy. The radiotherapy is usually given with capecitabine chemotherapy tablets.,All patients who take part in this trial will receive chemotherapy with gemcitabine and capecitabine, initially for 3 months. For patients that benefit from the chemotherapy, the initial 3 months of chemotherapy will be followed by one further month of chemotherapy, then radiotherapy in combination with an oral chemotherapy drug similar to capecitabine, called UFT.. UFT is given with another tablet called leucovorin, which enhances the effect of the UFT. A potential advantage of UFT over capecitabine is that it appears to cause less "hand and foot syndrome"; a redness and soreness of the palms and soles that often develops with capecitabine or flurouracil.Cetuximab (Erbitux) is an antibody treatment which targets the epidermal growth factor receptor, which is involved in cancer cell growth. Studies have shown that cetuximab can benefit patients with advanced colorectal cancer and when given with radiotherapy, cetuximab provides a survival benefit in patients with localised cancers of the head and neck.This study aims to find out if adding cetuximab to the radiotherapy will improve the response to the radiotherapy and UFT chemotherapy. In this study, half the patients will receive UFT with radiotherapy and another half will receive UFT plus cetuximab with radiotherapy after the initial 4 months of chemotherapy. Once these treatments are completed, patients may receive further treatment with the gemcitabine and capecitabine combination chemotherapy.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  09/H0406/32

• Date of REC Opinion

  26 Mar 2009

• REC opinion

  Further Information Favourable Opinion