The purpose of this study is to find out whether either trastuzumab or the combination of trastuzumab and pertuzumab with standard chemotherapy shows more activity against gastro-oesophageal adenocarcinoma than standard chemotherapy given before and after surgery and it can be safely administered.
This is a randomized phase II trial with an internal control. The randomization will be a 1:2:2 randomization (control: experimental arm 1: experimental arm 2). Potentially eligible patients will be screened centrally for the HER-2 status. After confirmation of HER-2 positive disease, eligible patients will be centrally randomized through the EORTC randomization system. A minimization technique will be used for random treatment allocation between the three treatment arms. Stratification will be done by histological subtype (intestinal/non-intestinal); Korea versus Europe; stage II versus III; node positive versus node negative.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
172
University Hospital Gent
Ghent, Flanders, Belgium
North Estonia Medical Centre
Tallinn, Estonia
CHRU de Besancon - Hopital Jean Minjoz
Besançon, France
CHRU de Lille - Hopital Huriez
Lille, France
CHU de Bordeaux - Group Hospitalier Sud - Hopital Haut-Lévêque
Pessac, France
CHU de Reims - Hôpital Robert Debré
Near Complete Pathological Response Rate
To increase the major pathological response rate (\< 10% vital tumor cells) to neoadjuvant treatment by integrating both trastuzumab and pertuzumab into perioperative chemotherapy for HER-2 positive, resectable gastric cancer.
Time frame: After 3 cycles (21 days) of neoadjuvant chemotherapy
Locoregional failure
Time frame: At the time of surgery and at 5 years
R0 resection rate
Time frame: At the time of surgery
Distant failure
Time frame: At the time of surgery and at 5 years
Progression-free survival
Time frame: 5 years after LPI
Recurrence-free survival
Time frame: 5 years after LPI
Overall survival
Time frame: 5 years after LPI
Toxicity
Time frame: 5 years after LPI
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Reims, France
Institut Gustave Roussy
Villejuif, France
Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum
Berlin, Germany
Universitaetsklinikum Carl Gustav Carus
Dresden, Germany
Kliniken Essen-Mitte - Evang. Huyssens-Stiftung
Essen, Germany
...and 38 more locations