Trials / Completed
CompletedNCT02205047
Neoadjuvant Study Using Trastuzumab or Trastuzumab With Pertuzumab in Gastric or Gastroesophageal Junction Adenocarcinoma
INtegratioN of Trastuzumab, With or Without Pertuzumab, Into periOperatiVe chemotherApy of HER-2 posiTIve stOmach caNcer: the INNOVATION-TRIAL
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 172 (actual)
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC · Network
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
- Malignant Neoplasm of Stomach
- Malignant Neoplasm of Cardio-esophageal Junction of Stomach
- Epidermal Growth Factor Receptor (EGFR) Protein Overexpression
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cisplatin | |
| DRUG | 5-fluorouracil or Capecitabine | |
| DRUG | Trastuzumab | |
| DRUG | Pertuzumab | |
| PROCEDURE | gastrectomy | D2 gastrectomy |
Timeline
- Start date
- 2015-07-15
- Primary completion
- 2022-12-22
- Completion
- 2024-12-31
- First posted
- 2014-07-31
- Last updated
- 2025-07-31
Locations
48 sites across 13 countries: Belgium, Estonia, France, Germany, Italy, Netherlands, Norway, Portugal, Singapore, South Korea, Spain, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT02205047. Inclusion in this directory is not an endorsement.