ST03: A randomized trial of perioperative epirubicin, cisplatin plus capecitabine (ECX) with or without bevacizumab (B) in patients (pts) with operable gastric, oesophagogastric junction (OGJ) or lower oesophageal adenocarcinoma
2012
TPS4143 Background: Perioperative ECX chemotherapy is a standard of care for localised gastric/OGJ/lower oesophageal adenocarcinoma (Cunningham NEJM 2006). B is a monoclonal antibody targeting VEGF-A, and in combination with chemotherapy results in improved response rates (RR) and progression free survival in advanced gastric cancer (Ohtsu JCO 2011). The aim of ST03 is to assess the safety and feasibility (stage I, first 200 pts) and efficacy (stage II) of the addition of B to perioperative ECX chemotherapy. Methods: ST03 is a multicentre, open-label, phase II/III randomised trial ongoing at 92 UK centres; sites in Germany will open in 2012. Eligibility criteria are histologically proven, untreated, resectable, lower oesophageal, OGJ or gastric adenocarcinoma; age ≥18 years; WHO PS 0-1; and adequate cardiac ejection fraction (EF). Exclusion criteria are TIA/CVA or MI ≤1 year; uncontrolled hypertension; ≥Grade II NYHA heart failure; recent gastrointestinal inflammatory conditions or major surgery/trauma/op...
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