NCT02205047: INNOVATION

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

Completed Phase 2 Last updated 31 July 2025

What this trial tests

Phase 2 trial testing Cisplatin in Malignant Neoplasm of Stomach in 172 participants. Completed in 31 December 2024.

Timeline

15 July 2015

Primary endpoint
22 December 2022

31 December 2024

Quick facts

Lead sponsor	European Organisation for Research and Treatment of Cancer - EORTC
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	172
Start date	15 July 2015
Primary completion	22 December 2022
Estimated completion	31 December 2024
Sites	48 locations across France, Italy, Netherlands, Belgium, Estonia, United Kingdom, Germany, Norway

Drugs / interventions tested

• Cisplatin (cisplatin) — full drug profile →
• 5-fluorouracil or Capecitabine — full drug profile →
• Trastuzumab (trastuzumab) — full drug profile →
• Pertuzumab (pertuzumab) — full drug profile →
• gastrectomy

Conditions studied

• Malignant Neoplasm of Stomach — all drugs for Malignant Neoplasm of Stomach →
• Malignant Neoplasm of Cardio-esophageal Junction of Stomach — all drugs for Malignant Neoplasm of Cardio-esophageal Junction of Stomach →
• Epidermal Growth Factor Receptor (EGFR) Protein Overexpression — all drugs for Epidermal Growth Factor Receptor (EGFR) Protein Overexpression →

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC — full company profile →

Who can join

18 and older, any sex, with Malignant Neoplasm of Stomach or Malignant Neoplasm of Cardio-esophageal Junction of Stomach. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical impact of tumour biology in the management of gastroesophageal cancer.
   Lordick F, Janjigian YY. · · 2016 · cited 119× · PMID 26925958 · DOI 10.1038/nrclinonc.2016.15
2. Epidermal Growth Factor Receptor Family and its Role in Gastric Cancer.
   Arienti C, Pignatta S, Tesei A. · · 2019 · cited 97× · PMID 31850207 · DOI 10.3389/fonc.2019.01308
3. EORTC-1203-GITCG - the "INNOVATION"-trial: Effect of chemotherapy alone versus chemotherapy plus trastuzumab, versus chemotherapy plus trastuzumab plus pertuzumab, in the perioperative treatment of HER2 positive, gastric and gastroesophageal junction adenocarcinoma on pathologic
   Wagner AD, Grabsch HI, Mauer M, Marreaud S, et al · · 2019 · cited 81× · PMID 31126258 · DOI 10.1186/s12885-019-5675-4
4. Perioperative chemotherapy for resectable gastric cancer: MAGIC and beyond.
   Choi AH, Kim J, Chao J. · · 2015 · cited 76× · PMID 26139980 · DOI 10.3748/wjg.v21.i24.7343
5. Perspectives of HER2-targeting in gastric and esophageal cancer.
   Gerson JN, Skariah S, Denlinger CS, Astsaturov I. · · 2017 · cited 68× · PMID 28387541 · DOI 10.1080/13543784.2017.1315406
6. Perioperative Treatment in Resectable Gastric Cancer: Current Perspectives and Future Directions.
   Petrillo A, Pompella L, Tirino G, Pappalardo A, et al · · 2019 · cited 49× · PMID 30901943 · DOI 10.3390/cancers11030399
7. The genomics and therapeutics of HER2-positive gastric cancer-from trastuzumab and beyond.
   Kelly CM, Janjigian YY. · · 2016 · cited 47× · PMID 27747089 · DOI 10.21037/jgo.2016.06.10
8. Progress and challenges in HER2-positive gastroesophageal adenocarcinoma.
   Zhao D, Klempner SJ, Chao J. · · 2019 · cited 46× · PMID 31101074 · DOI 10.1186/s13045-019-0737-2