PALLIATIVE EOX & OMEGAVEN IN OESOPHAGO-GASTRIC CANCER PATIENTS

• Research type

  Research Study

• Full title

  PHASE II TRIAL OF PALLIATIVE EPIRUBICIN, OXALIPLATIN & CAPECITABINE (EOX) CHEMOTHERAPY COMBINED WITH OMEGA-3 FISH OIL INFUSION (OMEGAVEN) IN PATIENTS WITH OESOPHAGO-GASTRIC CARCINOMA

• IRAS ID

  86988

• Contact name

  David Bowrey

• Sponsor organisation

  University Hospitals of Leicester NHS Trust

• Eudract number

  2011-003950-24

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The prognosis for patients with advanced oesophago-gastric cancer is poor. Approximately 16,000 patients in the UK die from the disease. In spite of new chemotherapy regimens, the average survival for these patients is around 9 months from diagnosis. Omegaven is an infusion comprising omega-3 fish oils. There is evidence that omega-3 fish oil supplementation can improve general well being and quality of life in patients receiving palliative chemotherapy for a number of different cancer types. It has also been suggested that omega-3 fish oil supplementation may reduce the toxicity of chemotherapy. At our unit, we have previously used omega-3 fish oils to treat patients in similar circumstances with advanced pancreatic cancer, with promising early results in terms of prognosis and in particular, quality of life. This clinical trial aims to see whether the addition of Omegaven to EOX chemotherapy, the most widely used regimen for patients with advanced oesophago-gastric cancer, will make this drug regimen more effective at killing oesophago-gastric cancer cells, such that disease progression is delayed. Forty-five patients who have been diagnosed with advanced oesophago-gastric cancer will be recruited over a two year period to receive standard chemotherapy and omega-3 fish oil supplementation. If results suggest that the combination of EOX and Omegaven is sufficiently effective, tolerable and feasible then it will be the intention of the trial team to take the combination forward to treat patients with advanced oesophago-gastric cancer in a randomised study.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  11/EM/0412

• Date of REC Opinion

  13 Jan 2012

• REC opinion

  Further Information Favourable Opinion