JPRN-jRCTs031230182招募中2 期
JCOG2203: A randomized controlled phase II/III trial of neoadjuvant chemotherapy for Japanese patients with esophagogastric junction adenocarcinoma - NEO-JPEG
KUROKAWA Yukinori0 个研究点目标入组 460 人开始时间: 2023年6月27日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 460
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
- >= 18age old 至 <= 79age old（—）
- 性别
- All
入选标准
- •(1) Histologically proven esophagogastric junction adenocarcinoma
- •(2) Esophagogastric junction adenocarcinoma of Siewert type I or type II based on endoscopy
- •(3) clinical Stage III or IVA (except for T4b) based on the cervical/thoracic/abdominal/pelvic contrast-enhanced CT (UICC-TNM 8th edition)
- •(4) Neither Borrmann type 4 nor large (8cm or more) type 3
- •(5) No bulky lymph node metastasis by abdominal contrast-enhanced CT
- •(6) Judged that R0 resection is possible
- •(7) Age between 18 and 79 at registration
- •(8) Performance Status(ECOG) 0 or 1
- •(9) No prior treatment of endocrine therapy, chemotherapy, molecularly-targeted therapy, and immunotherapy against any other malignancies within 5 years
- •(10) No prior treatment of radiotherapy to cervical, thoracic, and upper abdominal against any other malignancies
- •(11) No prior surgery for stomach and esophagus except for the endoscopic resection by EMR/ESD
- •(12) Sufficient organ function
- •i) Neutrophil >= 1,500/mm3
- •ii) Platelet >= 10x10,000/mm3
- •iii) Hb >= 8.0g/dL
- •iv) T.Bil <= 1.5 mg/dL
- •v) AST <= 100 U/L
- •vi) ALT <= 100 U/L
- •vii) CCr >= 50 mL/min
- •viii) SpO2 >= 95%(room air)
- •(13) Written informed consent from patient
排除标准
- •(1) Synchronous or metachronous (within 5 years) malignancies.
- •(2) Infectious disease requiring systemic treatment.
- •(3) Body temperature of 38 degrees Celsius or higher.
- •(4) Female during pregnancy, within 28 days of postparturition, or during lactation.
- •(5) Psychological disorder difficult to participate in this clinical study.
- •(6) Receiving continuous systemic corticosteroid or immunosuppressant treatment.
- •(7) Under treatment with flucytosine, phenytoin, or warfarin.
- •(8) History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration.
- •(9) Uncontrolled valvular disease, dilated cardiomyopathy, and hypertrophic cardiomyopathy.
- •(10) Uncontrolled arterial hypertension.
- •(11) Uncontrolled diabetes mellitus.
- •(12) Severe emphysema, interstitial pneumonia, or pulmonary fibrosis based on chest CT.
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