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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
DC Field | Value | Language |
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dc.contributor.author | 라선영 | - |
dc.date.accessioned | 2019-12-18T01:14:07Z | - |
dc.date.available | 2019-12-18T01:14:07Z | - |
dc.date.issued | 2019 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/173428 | - |
dc.description.abstract | BACKGROUND: 10-20% of patients with gastric cancer (GC) have HER2+ tumors. Addition of trastuzumab (T) to cisplatin/fluoropyrimidine-based chemotherapy (CT) improved survival in metastatic, HER2+ GC. When pertuzumab (P) was added to neoadjuvant T and CT, a significant increase in histopathological complete response rate was observed in HER2+ breast cancer. This study aims to investigate the added benefit of using both HER2 targeting drugs (T alone or the combination of T + P), in combination with perioperative CT for localized HER2+ GC. METHODS: This is a prospective, randomized, open-label, phase II trial. HER2 status from patients with resectable GC (UICC TNM7 tumor stage Ib-III) will be centrally determined. Two hundred and-fifteen patients from 52 sites in 14 countries will be centrally randomized (1:2:2 ratio) to one of the following treatment arms: 1. Standard: CT alone. CT regimens will be FLOT (5-FU, leucovorin, oxaliplatin, taxotere) CapOx (capecitabine, oxaliplatin) or FOLFOX (5-FU, leucovorin, oxaliplatin) according to investigator's choice in Europe, and cisplatin/capecitabine in Asia. 2. Experimental arm 1: CT as in control group, plus T (8 mg/kg loading dose, followed by 6 mg/kg every 3 weeks) at day 1, independent of CT chosen for 3 cycles of 3 weeks before and after surgery. 3. Experimental arm 2: CT plus T as in experimental arm 1, plus P (840 mg every 3 weeks) on day 1. Adjuvant treatment with T or T + P will continue for 17 cycles in total. Stratification factors are: histology (intestinal/non-intestinal); region (Asia vs Europe); location (GEJ vs non-GEJ); HER2 immunohistochemistry score (IHC 3+ vs IHC 2+/FISH+) and chemotherapy regimen. Primary objective is to detect an increase in the major pathological response rate from 25 to 45% either with CT plus T alone, or with CT plus the combination of T and P. DISCUSSION: Depending on the results of the INNOVATION trial, the addition of HER2 targeted treatment with either T or T and P to CT may inform future study designs or become a standard in the perioperative management HER2+ GC. TRIAL REGISTRATION: This article reports a health care intervention on human participants and was registered on July 10, 2014 under ClinicalTrials.gov identifier: NCT02205047 ; EudraCT: 2014-000722-38. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | BioMed Central | - |
dc.relation.isPartOf | BMC CANCER | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.title | 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 | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Anna Dorothea Wagner | - |
dc.contributor.googleauthor | Heike I. Grabsch | - |
dc.contributor.googleauthor | Murielle Mauer | - |
dc.contributor.googleauthor | Sandrine Marreaud | - |
dc.contributor.googleauthor | Carmela Caballero | - |
dc.contributor.googleauthor | Peter Thuss-Patience | - |
dc.contributor.googleauthor | Lothar Mueller | - |
dc.contributor.googleauthor | Annelie Elme | - |
dc.contributor.googleauthor | Markus Hermann Moehler | - |
dc.contributor.googleauthor | Uwe Martens | - |
dc.contributor.googleauthor | Yoon-Koo Kang | - |
dc.contributor.googleauthor | Sun Young Rha | - |
dc.contributor.googleauthor | Annemieke Cats | - |
dc.contributor.googleauthor | Masanori Tokunaga | - |
dc.contributor.googleauthor | Florian Lordick | - |
dc.identifier.doi | 10.1186/s12885-019-5675-4 | - |
dc.contributor.localId | A01316 | - |
dc.relation.journalcode | J00351 | - |
dc.identifier.eissn | 1471-2407 | - |
dc.identifier.pmid | 31126258 | - |
dc.subject.keyword | Gastric cancer | - |
dc.subject.keyword | Gastro-esophageal junction cancer | - |
dc.subject.keyword | HER2 | - |
dc.subject.keyword | Perioperative chemotherapy | - |
dc.subject.keyword | Pertuzumab | - |
dc.subject.keyword | Trastuzumab | - |
dc.contributor.alternativeName | Rha, Sun Young | - |
dc.contributor.affiliatedAuthor | 라선영 | - |
dc.citation.volume | 19 | - |
dc.citation.number | 1 | - |
dc.citation.startPage | 494 | - |
dc.identifier.bibliographicCitation | BMC CANCER, Vol.19(1) : 494, 2019 | - |
dc.identifier.rimsid | 64156 | - |
dc.type.rims | ART | - |
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