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Multicenter, explorative phase II study of perioperative 5-FU, leucovorin, docetaxel, and oxaliplatin (FLOT) in combination with Trastuzumab in patients with HER2-positive, locally advanced resectable...

Update Il y a 4 ans
Reference: EUCTR2011-001507-13

Multicenter, explorative phase II study of perioperative 5-FU, leucovorin, docetaxel, and oxaliplatin (FLOT) in combination with Trastuzumab in patients with HER2-positive, locally advanced resectable adenocarcinoma of the gastroesophageal junction or stomach (HerFLOT) Multizentrische, Explorative Phase II Studie mit perioperativer Gabe von 5-FU, Leucovorin, Docetaxel und Oxaliplatin (FLOT) in Kombination mit Trastuzumab bei Patienten mit HER2-positivem, lokal fortgeschrittenem, resektablem Adenokarzinom des gastroösophagealen Übergangs oder des Magens

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Extract

Primary objective of the study is to estimate the efficacy of the trastuzumab/FLOT combination consisting of 5-FU/leucovorin, oxaliplatin, docetaxel and the antibody in locoregional cancer of the stomach or gastroesophageal junction, based on the rate of complete pathological responses (percentage of patients with pCR referring to the total number of enrolled and eligible patients), as evaluated centrally by a reference pathologists.

Inclusion criteria

  • HER2-positive, locally advanced, resectable adenocarcinoma of the gastroesophageal junction or stomch

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