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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

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dc.contributor.author라선영-
dc.date.accessioned2019-12-18T01:14:07Z-
dc.date.available2019-12-18T01:14:07Z-
dc.date.issued2019-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/173428-
dc.description.abstractBACKGROUND: 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.statementOfResponsibilityopen-
dc.languageEnglish-
dc.publisherBioMed Central-
dc.relation.isPartOfBMC CANCER-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.titleEORTC-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.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
dc.contributor.googleauthorAnna Dorothea Wagner-
dc.contributor.googleauthorHeike I. Grabsch-
dc.contributor.googleauthorMurielle Mauer-
dc.contributor.googleauthorSandrine Marreaud-
dc.contributor.googleauthorCarmela Caballero-
dc.contributor.googleauthorPeter Thuss-Patience-
dc.contributor.googleauthorLothar Mueller-
dc.contributor.googleauthorAnnelie Elme-
dc.contributor.googleauthorMarkus Hermann Moehler-
dc.contributor.googleauthorUwe Martens-
dc.contributor.googleauthorYoon-Koo Kang-
dc.contributor.googleauthorSun Young Rha-
dc.contributor.googleauthorAnnemieke Cats-
dc.contributor.googleauthorMasanori Tokunaga-
dc.contributor.googleauthorFlorian Lordick-
dc.identifier.doi10.1186/s12885-019-5675-4-
dc.contributor.localIdA01316-
dc.relation.journalcodeJ00351-
dc.identifier.eissn1471-2407-
dc.identifier.pmid31126258-
dc.subject.keywordGastric cancer-
dc.subject.keywordGastro-esophageal junction cancer-
dc.subject.keywordHER2-
dc.subject.keywordPerioperative chemotherapy-
dc.subject.keywordPertuzumab-
dc.subject.keywordTrastuzumab-
dc.contributor.alternativeNameRha, Sun Young-
dc.contributor.affiliatedAuthor라선영-
dc.citation.volume19-
dc.citation.number1-
dc.citation.startPage494-
dc.identifier.bibliographicCitationBMC CANCER, Vol.19(1) : 494, 2019-
dc.identifier.rimsid64156-
dc.type.rimsART-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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