JCOG1509: Phase III trial to evaluate the efficacy of neoadjuvant chemotherapy with S-1 plus oxaliplatin followed by D2 gastrectomy with adjuvant S-1 in locally advanced gastric cancer. - NAGISA trial

TERASHIMA Masanori0 个研究点目标入组 470 人开始时间: 2019年3月18日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) Histologically proven gastric adenocarcinoma.
•2) Clinical T3/T4 by imaging.
•3) No tumor invasion to pancreas head from primary tumor and/or metastatic lymph node
•4) Enlarged lymph node (>=8mm in minor axis or >=10mm in major axis) by contrast-enhanced abdominal computed tomography (CT).
•5) No bulky lymph nodes (>=3 cm x 1 or >=1.5 cm x 2 in major axis) along the celiac, splenic, common or proper hepatic arteries, or the superior mesenteric vein by contrast-enhanced abdominal computed tomography.
•6) No distant metastasis based on contrast-enhanced thoracic/abdominal/pelvic CT.
•7) The macroscopic tumor type is neither Borrmann type 4 (linitis plastica) nor large (8 cm or more) type 3.
•8) No esophageal invasion or an invasion of 3 cm or less.
•9) No gastric stump cancer.
•10) When a staging laparoscopy is performed before registration, non-curable factors other than positive lavage cytology are not revealed.
•11) Sufficient oral intake.
•12) No prior chemotherapy, radiotherapy, or endocrine therapy for any malignancies within five years.
•13) Aged between 20 and 79 years old.
•14) Eastern Cooperative Oncology Group performance status of 0 or 1.
•15) Sufficient organ function.
•i. Neutrophil >= 1,500/mm3
•ii. Hb >= 8.0 g/dL
•iii. Platelet >= 100,000/mm3
•iv. T.Bil <= 2.0 mg/dL
•v. AST <= 100 IU/L
•vi. ALT <= 100 IU/L
•vii. Creatinine <= 1.3 mg/dL
•viii. CCr >= 60mL/min/body
•16) Written informed consent.

•1) Synchronous or metachronous (within 5 years) malignancies.
•2) Infectious disease requiring systemic treatment.
•3) Body temperature of 38 degrees Celsius or higher.
•4) During pregnancy, within 28 days of postparturition, or during lactation.
•5) Severe mental disease.
•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) Poorly controlled diabetes.
•10) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema based on chest CT.

发起方

TERASHIMA Masanori