NL-OMON53087招募中2 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 in Treatment of Cancer (EORTC)0 个研究点目标入组 3 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •* All patients (HER-2 positive and negative) should be registered in the
- •trial as soon as possible after written informed consent for screening
- •according to ICH/GCP, and national/local regulations.
- •* Histologically proven, gastric or GE-junction adenocarcinoma (Siewert I-III)
- •* Absence of distant metastases on CT scan of thorax and abdomen
- •* Patient medically fit for gastrectomy/oesophagectomy as decided by the
- •investigator
- •* Age >= 18 years
- •* WHO performance status 0 - 1,
- •Randomization:
- •- HER-2 overexpression, as determined by central testing using
- •immunohistochemistry (IHC 3+) or the combination of IHC 2+ and HER-2 FISH
- •* Amenable to gastrectomy/oesophagectomy with curative intent as confirmed by a
- •multidisciplinary team discussion
- •* UICC (7th edition) tumor 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 and T2 tumors and 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
- •* Total bilirubin within normal limits (if the patient has documented Gilbert*s
- •disease <= 1.5 × ULN or direct bilirubin <= ULN)
- •* Aspartate transaminase (AST) and 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
- •- Absence of any psychological, familial, sociological or geographical
- •condition potentially hampering compliance with study protocol & follow-up
- •- For women who are not postmenopausal (> 12 months of nontherapy 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 treatment period &for at
- •least 7 months after last
- •treatment dose
- •- Negative serum pregnancy test
- •- For men: agreement to remain abstinent or use a condom plus additional
- •contraceptive method that together result in a failure rate of < 1% per year
- •during the treatment period &for at least 7
- •months after last dose of study treatment.
排除标准
- •* No prior chemo- or antibody therapy
- •* No 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
- •* No 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.
- •* No known hypersensitivity to the components of trastuzumab, pertuzumab,
- •cisplatin, oxaliplatin, docetaxel, 5-FU or capecitabine
- •- no patients with interstitial lung disease
- •* Absence of preexisting neuropathy > grade I
- •* No known dihydropyrimidine dehydrogenase (DPD) deficiency (testing not
- •required). In case of specific recommendations due to institutional and/or
- •national guidelines please proceed accordingly.
- •* No ongoing or concomitant use of the antiviral drug sorivudine or its
- •chemically related analogs, such as brivudine
- •* No chronic treatment with high-dose intravenous corticosteroids (> 10 mg/day
- •prednisone equivalents)
- •* No 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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