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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000722-38 | EudraCT Number | ||
| MO28922 | Other Grant/Funding Number | Roche |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard chemotherapy | Active Comparator | Cisplatin/capecitabine or cisplatin/5-fluorouracil |
|
| Experimental arm 1 | Experimental | Cisplatin/capecitabine plus trastuzumab or cisplatin/5-fluorouracil plus trastuzumab |
|
| Experimental arm 2 | Experimental | cisplatin/capecitabine plus trastuzumab and pertuzumab or cisplatin/5-fluorouracil plus trastuzumab and pertuzumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin | Drug |
| ||
| 5-fluorouracil or Capecitabine |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After 3 cycles (21 days) of neoadjuvant chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Locoregional failure | At the time of surgery and at 5 years | |
| R0 resection rate | At the time of surgery | |
| Distant failure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Dorothea Wagner, MD | Centre hospitalier universitaire vaudois, Lausanne | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Gent | Ghent | Flanders | 9000 | Belgium | ||
| North Estonia Medical Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31126258 | Derived | Wagner AD, Grabsch HI, Mauer M, Marreaud S, Caballero C, Thuss-Patience P, Mueller L, Elme A, Moehler MH, Martens U, Kang YK, Rha SY, Cats A, Tokunaga M, Lordick F. 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 response rate: a randomized phase II-intergroup trial of the EORTC-Gastrointestinal Tract Cancer Group, Korean Cancer Study Group and Dutch Upper GI-Cancer group. BMC Cancer. 2019 May 24;19(1):494. doi: 10.1186/s12885-019-5675-4. | |
| 27486629 |
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| Drug |
|
| Trastuzumab | Drug |
|
| Pertuzumab | Drug |
|
| gastrectomy | Procedure | D2 gastrectomy |
|
| At the time of surgery and at 5 years |
| Progression-free survival | 5 years after LPI |
| Recurrence-free survival | 5 years after LPI |
| Overall survival | 5 years after LPI |
| Toxicity | 5 years after LPI |
| Tallinn |
| 13419 |
| Estonia |
| CHRU de Besancon - Hopital Jean Minjoz | Besançon | 25030 | France |
| CHRU de Lille - Hopital Huriez | Lille | 59037 | France |
| CHU de Bordeaux - Group Hospitalier Sud - Hopital Haut-Lévêque | Pessac | 33075 | France |
| CHU de Reims - Hôpital Robert Debré | Reims | 51092 | France |
| Institut Gustave Roussy | Villejuif | France |
| Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum | Berlin | 13353 | Germany |
| Universitaetsklinikum Carl Gustav Carus | Dresden | 01307 | Germany |
| Kliniken Essen-Mitte - Evang. Huyssens-Stiftung | Essen | 45136 | Germany |
| Universitaetsmedizin Goettingen - Georg-August Universitaet | Göttingen | 37075 | Germany |
| Asklepios Kliniken GmbH - Asklepios Klinik Barmbek | Hamburg | 22291 | Germany |
| SLK-Kliniken Heilbronn GmbH | Heilbronn | 74078 | Germany |
| Onkologische Unter-Ems (Leer-Papenburg-Emden) | Leer | 26789 | Germany |
| Universitaetsklinikum Leipzig | Leipzig | Germany |
| Johannes Gutenberg Universitaetskliniken - Mainz University Medical Center | Mainz | 55101 | Germany |
| Ludwig-Maximilians-Universitaet München - Campus Grosshadern | München | 81377 | Germany |
| Technische Universität München - Klinikum Rechts der Isar | München | Germany |
| Azienda Ospedaliera Papa Giovanni XXIII | Bergamo | 24127 | Italy |
| Istituto Europeo di Oncologia | Milan | 20141 | Italy |
| Azienda Ospedaliera Ordine Mauriziano di Torino | Torino | Italy |
| The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis | Amsterdam | 1066 CX | Netherlands |
| Academisch Medisch Centrum - UMC Universiteit van Amsterdam - site: VUMC | Amsterdam | 1081 HV | Netherlands |
| Oslo University Hospital - Radiumhospitalet | Oslo | 0379 | Norway |
| Instituto Portugues de Oncologia de Lisboa Francisco Gentil | Lisbon | Portugal |
| Instituto Portugues De Oncologia - Centro Do Porto | Porto | 4200-072 | Portugal |
| National Cancer Centre Singapore | Singapore | 169610 | Singapore |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Gangnam Severance Hospital | Seoul | 135-720 | South Korea |
| Hallym University Sacred Heart Hospital | Seoul | 14068 | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Gangnam Severance Hospital | Seoul | South Korea |
| Hallym University Sacred Heart Hospital | Seoul | South Korea |
| Severance Hospital YUCM | Seoul | South Korea |
| Severance Hospital, Yonsei University Health System (YUCM) | Seoul | South Korea |
| The Catholic University of Korea-St. Vincent's Hospital | Suwon-Si Gyeonggi-do | 16247 | South Korea |
| Institut Catala d'Oncologia - ICO L'Hospitalet | L'Hospitalet de Llobregat | Barcelona | 08908 | Spain |
| ICO Badalona (Institut Catala d'Oncologia) - Hospital Germans Trias i Pujol | Badalona | 08916 | Spain |
| Hospital Universitari Vall d'Hebron - Institut Oncologia | Barcelona | 08035 | Spain |
| ICO Girona - Hospital Dr Josep Trueta (Institut Catala d'Oncologia) | Girona | 17007 | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital Clinico Universitario De Valencia | Valencia | 46010 | Spain |
| Hôpitaux Universitaires de Genève - HUG | Geneva | 1211 | Switzerland |
| Centre Hospitalier Universitaire Vaudois | Lausanne | Switzerland |
| University Hospitals Birmingham NHS - UHB-Queen Elisabeth MC | Birmingham | B15 2TH | United Kingdom |
| University College London Hospitals (UCLH) - NHS Foundation Trust | London | United Kingdom |
| The Christie NHS Foundation Trust | Manchester | United Kingdom |
| Royal Marsden Hospital - site: Sutton, Surrey | Sutton | SM2 5PT | United Kingdom |
| Derived |
| Integration of Trastuzumab, with or without Pertuzumab, into Perioperative Chemotherapy of HER2- Positive Stomach Cancer: The INNOVATION Trial (EORTC-1203-GITCG). Oncol Res Treat. 2016;39(3):153-4; discussion 155. doi: 10.1159/000444702. No abstract available. |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D005472 | Fluorouracil |
| D000069287 | Capecitabine |
| D000068878 | Trastuzumab |
| C485206 | pertuzumab |
| D005743 | Gastrectomy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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