Neoadjuvant Study Using Trastuzumab or Trastuzumab With Pertuzumab in Gastric or Gastroesophageal Junction Adenocarcinoma — INNOVATION  

Malignant Neoplasm of Stomach Clinical Trial

Official title: INtegratioN of Trastuzumab, With or Without Pertuzumab, Into periOperatiVe chemotherApy of HER-2 posiTIve stOmach caNcer: the INNOVATION-TRIAL

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Epidermal Growth Factor Receptor (EGFR) Protein Overexpression
• Malignant Neoplasm of Cardio-esophageal Junction of Stomach
• Malignant Neoplasm of Stomach
• Neoplasms
• Stomach Neoplasms

• NCT number: NCT02205047
• Study type: Interventional
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 15, 2015
• Completion date: December 31, 2028