EUCTR2014-000722-38-EE进行中（未招募）1 期
INtegratioN of trastuzumab, with or without pertuzumab, into periOperatiVe chemotherApy of HER-2 posiTIve stOmach caNcer: the INNOVATION-TRIAL - INNOVATIO
European Organisation for Research and Treatment of Cancer0 个研究点目标入组 215 人开始时间: 2015年3月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 215
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Registration
- •For the determination of the HER-2 status, European sites will have the
- •choice, patient by patient, between the two following options:
- •a) Assessment of the HER-2 status of the potentially eligible patient in the
- •central lab
- •b) Assessment of the HER-2 status by IHC only in the local lab and
- •mandatory confirmation of the HER-2 positive result in the central lab.
- •Important note:
- •Despite excellent pathologists and quality-controlled testing in local
- •pathology laboratories, potential discrepancies between the peripheral
- •and central lab in the interpretation of IHC results are well known. In
- •order not to lose potentially eligible patients for the trial it is mandatory
- •that the material from all patients with any HER-2 positivity (IHC 1+ or
- •more) in the local lab must be sent to the central pathology laboratory
- •as specified below:
- •? All patients (HER-2 positive and negative) should be registered in the trial asap after written informed consent for screening according to ICH/GCP & national/local regulations
- •? Histologically proven, gastric or GE-junction adenocarcinoma (Siewert I-III)
- •? Absence of distant metastases on CT scan of thorax & abdomen
- •? Patient medically fit for gastrectomy/oesophagectomy as decided by investigator
- •? Age = 18 years
- •? WHO performance status 0 – 1
- •2) RANDOMIZATION
- •? HER-2 overexpression, as determined by central testing using immunohistochemistry (IHC 3+) or the combination of IHC 2+ & HER-2 FISH positive (please see pathology guidelines)
- •? Amenable to gastrectomy/oesophagectomy with curative intent confirmed by multidisciplinary team discussion
- •? UICC tumor (7th edition) stage Ib to III, as defined by CT scan and/or MRI Endosonography (EUS) is recommended but not mandatory. EUS should especially be considered to distinguish T1&T2 tumors
- •&to evaluate local resectability. (In case of conflicting results of CT scan and/or MRI and endoscopic ultrasound, the final decision on which finding the staging is based should be taken by the multidisciplinary team
- •? The cardiac ejection fraction (LVEF) as determined by echocardiography,MUGA or cardiac MRI should be at least 55%
- •? Adequate organ function:
- •? White blood cell count (WBC) > 3 x 109/L
- •? Absolute neutrophil count (ANC) > 1.5 x 109/L
- •? Platelets = 100 x 109/L
- •? Hemoglobin = 9 g/dL (transfusions are permitted to reach this value)
- •? Estimated glomerular filtration rate (eGFR) according to MDRD should be > 50 ml/min (for patients treated with oxaliplatin-based regimens upfront)
- •NOTE: For patients that will receive CISPLATIN upfront a GFR > 60 ml/min is required
- •? Total bilirubin within normal limits (if the patient has documented Gilbert’s disease = 1.5 × ULN or direct bilirubin = ULN)
- •? Aspartate transaminase (AST) & alanine transaminase (ALT) = 2.5 × ULN
- •? Absence of preexisting neuropathy > grade I
- •? Investigator and patient have to agree to replace any oral anticoagulations by subcutaneous administration of low-molecular weight heparin (LMWH) in equivalent doses before treatment start, or if on oral anticoagulations &unwilling to switch to LMWH, patients have to be treated with mandatory 5-FU i.v. instead of capecitabine
- •? Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with study protocol & follow-up schedule; those conditions should be discussed with the patient before registration in trial
- •? For women who are not postmenopausal (> 12 months of non- therapy induced amenorrhea)or surgi
排除标准
- •2) Randomization
- •?Prior chemo- or antibody therapy
- •?History of significant cardiac disease defined as:
- •-Symptomatic CHF (NYHA classes II-IV, see Appendix D)
- •-High-risk uncontrolled arrhythmias, i.e. atrial tachycardia with a heart rate > 100/min at rest, significant ventricular arrhythmia (ventricular tachycardia) or higher-grade AV-block (second degree AV-block Type 2 [Mobitz 2] or third degree AV-block)
- •-History of myocardial infarction within 6 months prior to randomization
- •-Clinically significant valvular heart disease
- •?Central nervous system metastasis or leptomeningeal tumor spread. For patients without any neurological symptoms, a brain MRI is recommended, but not obligatory. For patients with any clinical symptoms, which may be attributed to brain metastases, a brain MRI is compulsory to rule out cerebral metastases.
- •?Known hypersensitivity to the components of trastuzumab, pertuzumab, oxaliplatin, docetaxel, 5-FU or capecitabine
- •?Patients with interstitial lung disease
- •?Known dihydropyrimidine dehydrogenase (DPD) deficiency (testing not required). In case of specific recommendations due to institutional and/or national guidelines please proceed accordingly
- •?Ongoing or concomitant use of the antiviral drug sorivudine or its chemically related analogs, such as brivudine
- •?Chronic treatment with high-dose intravenous corticosteroids (> 10 mg/day prednisone equivalents)
- •?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.
- •? Female patients should NOT be breast feeding
研究者
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