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Trial of adjuvant 5FU infusional chemotherapy

Disease site: Breast cancer

Treatment modality: Chemotherapy

Status: Closed

Trial details

Randomised trial comparing the efficacy and toxicity of adjuvant chemotherapy (infusional 5FU, epirubicin and cisplatin) with conventional FEC (5FU, epirubicin and cyclophosphamide) in women requiring chemotherapy for poor prognosis breast cancer, irrespective of age and nodal status. 348 patients were randomised from 11 centres between May 1995 and January 2002 to receive either infusional 5-fluorouracil (5-FU) by daily 24 hour continuous infusion via a Hickman line for 18 weeks with epirubicin and cisplatin given as intravenous bolus injections, or 5FU, epirubicin and cyclophosphamide given as intravenous bolus injection. Both regimens were repeated 3 weekly for 6 courses. All patients were offered tamoxifen 20mg orally daily in addition to chemotherapy.

Chief Investigator: Professor I. Smith, Royal Marsden NHS Foundation Trust

ISRCTN: 83324925

Publications and presentations

Sirohi B, A'Hern R, Coombes G, Bliss JM, Hickish T, Perren T, Crawford M, O'Brien M, Iveson T, Ebbs S, Skene A, Laing R, Smith IE. A randomised comparative trial of infusional ECisF versus conventional FEC as adjuvant chemotherapy in early breast cancer: the TRAFIC trial. Ann. Oncol. 2010;21(8):1623-29

Clinical trials

Division of Clinical Studies

The division carries out or coordinates high-quality trials and translational research at both an early phase – typically to test new targeted drugs – and a later stage.