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.
Who can participate
Age range18 Years
SexALL
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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 …
What they're measuring
1
Near Complete Pathological Response Rate
Timeframe: After 3 cycles (21 days) of neoadjuvant chemotherapy
Trial details
NCT IDNCT02205047
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC