Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epidermal Growth Factor Receptor (EGFR) Protein Overexpression | — | UNRESOLVED | — |
| Malignant Neoplasm of Cardio-esophageal Junction of Stomach | Gastric Neoplasm | PROBABILISTIC | 0.70 |
| Malignant Neoplasm of Stomach | Malignant Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluorouracil or Capecitabine | Drug | — | UNRESOLVED |
| Cisplatin | Drug | Cisplatin | ALIAS |
| gastrectomy | Procedure | — | UNRESOLVED |
| Pertuzumab | Drug | Pertuzumab | ALIAS |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Standard chemotherapy
- description
- Cisplatin/capecitabine or cisplatin/5-fluorouracil
- interventionNames
- Drug: Cisplatin
- Drug: 5-fluorouracil or Capecitabine
- Procedure: gastrectomy
- type
- EXPERIMENTAL
- label
- Experimental arm 1
- description
- Cisplatin/capecitabine plus trastuzumab or cisplatin/5-fluorouracil plus trastuzumab
- interventionNames
- Drug: Cisplatin
- Drug: 5-fluorouracil or Capecitabine
- Drug: Trastuzumab
- Procedure: gastrectomy
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven, gastric or gastroesophageal (GE)-junction adenocarcinoma (Siewert I-III) * Patient medically fit for gastrectomy/oesophagogastrectomy as decided by the investigator * Age ≥ 18 years * WHO performance status 0 - 1 * HER-2 overexpression * Amenable to gastrectomy/oesophagectomy * The cardiac ejection fraction (LVEF), as determined by echocardiography, multiple gated acquisition scan (MUGA) or cardiac MRI should be at least 50 % * Adequate organ function * written informed consent * For women who are not postmenopausal (\> 12 months of non-therapy induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of \< 1% per year during the treatment period and for at least 12 months after the last treatment dose * For men: agreement to remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \< 1% per year during the treatment period and for at least 12 months after the last dose of study treatment. Abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g. calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods for contraception. Exclusion Criteria: * Absence of distant metastases on CT scan of thorax and abdomen * prior chemo- or antibody therapy * history of significant cardiac disease * current uncontrolled hypertension * known hypersensitivity to the components of trastuzumab, pertuzumab, cisplatin, 5-follow-up or capecitabine * known dihydropyrimidine dehydrogenase (DPD) deficiency * ongoing or concomitant use of the antiviral drug sorivudine or its chemically related analogs, such as brivudine * chronic treatment with high-dose intravenous corticosteroids * previous malignancy within the last 5 years, with the exception of adequately treated cervical carcinoma in situ, localized non-melanoma skin cancer, or other curatively treated cancer without impact on the patient's overall prognosis according to the judgment of the investigator. * psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * pregnant or breast feeding
References
Publications (2)
- DERIVEDWagner 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. PMID 31126258
- DERIVEDIntegration 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. PMID 27486629