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Integration of Trastuzumab with or without Pertuzumab into the perioperative chemotherapy in HER2-positive gastric cancer: the Innovation study

Laufzeit: 01.01.2015 - 31.12.2022

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Kurzfassung


This is a randomized phase II study with internal control. The randomization takes place in the ratio 1:2:2 (control: Experimental Group 1: Experimental Group 2). Potentially appropriate patients are being examined centrally with regard to their HER2 status.  After confirmation of the HER2-positive disease, the participating patients are centrally randomized with the EORTC system of randomization. A minimization technique is used for the random assignment to the three treatment groups....This is a randomized phase II study with internal control. The randomization takes place in the ratio 1:2:2 (control: Experimental Group 1: Experimental Group 2). Potentially appropriate patients are being examined centrally with regard to their HER2 status.  After confirmation of the HER2-positive disease, the participating patients are centrally randomized with the EORTC system of randomization. A minimization technique is used for the random assignment to the three treatment groups. The layering (stratification) is done according to histological subtype (intestinal/non-intestinal); Korea versus Europe; Tumor localisation in gastro-esophageal transition (GET) versus residual stomach (non-GET) and HER2 IHC 3 + versus IHC2 +/fish +.
 
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