JCOG1507: A phase III trial to confirm S-1 adjuvant chemotherapy for pathological stage II/III vulnerable elderly gastric cancer patients who underwent gastric resection - BIRDIE

YOSHIDA Kazuhiro0 个研究点目标入组 170 人开始时间: 2019年3月13日最近更新: 2023年11月20日

适应症

试验速览

暂无简介。

•1) Histologically proven gastric adenocarcinoma
•2) Pathological stage II/III defined by 14th edition of Japanese Classification of Gastric Carcinoma
•3) Received R0 gastrectomy with D1+ or D2 lymphadenectomy
•4) Either of the following surgery performed;
•i) Open laparotomy regardless of clinical stage and type of gastrectomy
•ii) Laparoscopic or laparoscope-assisted gastrectomy regardless of clinical stage and type of gastrectomy
•5) Either of the followings:
•i) Weight loss < 15% and 30 mL/min <= Ccr for the patients received total gastrectomy
•ii) Weight loss < 15% and 30 mL/min <= Ccr < 80 mL/min for the patients not received total gastrectomy
•6) Within 5 to 12 weeks after surgery
•7) Aged 80 years old or older
•8) Performance status of 0 or 1
•9) No gastric stump cancer
•10) No previous treatment of chemotherapy, radiation therapy, or molecular-target therapy for any neoplasms. (History of hormone therapy more than one year ago is eligible.)
•11) Enough oral intake
•12) No dementia, or dementia with family support to continue protocol treatment or examinations
•13) Sufficient organ functions
•14) No ischemic change on ECG
•15) Written informed consent

•1) Synchronous double/multiple cancer or metachronous double/multiple cancer with progression free period of 5 years or shorter
•2) Infectious disease requiring systemic treatment
•3) Body temperature of 38 degrees Celsius or higher
•4) Severe mental disease
•5) Requiring systemic steroid medication (>= 5 mg/day of prednisolone)
•6) Under treatment by flucytosine, phenytoin, or warfarin potassium
•7) Uncontrolled diabetes mellitus
•8) Uncontrolled hypertension
•9) Unstable angina pectoris (angina developed or attack worsened within recent 3 weeks) or previous myocardial infarction within 6 months
•10) Positive for HBs antigen
•11) Severe interstitial pneumonia, severe lung fibrosis, or severe emphysema
•12) Surgical morbidity such as infection, leakage, intestinal bleeding, pancreatic fistula, and so on is not improved

发起方

YOSHIDA Kazuhiro