Randomized phase III trial comparing combined systemic and intraperitoneal chemotherapy versus systemic chemotherapy as adjuvant or perioperative chemotherapy in patients with type 4 advanced gastric cancer - PHOENIX-GC2 trial

Ishigami Hironori0 个研究点目标入组 262 人开始时间: 2020年8月17日最近更新: 2023年10月17日

试验速览

暂无简介。

•Confirmation before temporary registration
•1)Pathologically diagnosed as gastric adenocarcinoma of the general type.
•2)The naked eye type is type 4 (diffuse infiltration type)
•3)Suspected invasion of the primary lesion to the subserosal layer(cT3-4) by diagnostic imaging
•4)No Bulky N lymph node metastasis on CT.
•5)No clear distant metastasis on image diagnosis.
•6)Age >=20, <75
•7)ECOG Performance Status:0 or 1
•8)No chemotherapy or radiation for gastric cancer.
•9)Adequate function of important organs (within 14 days before registration)
•1.NEU >=1,500/mm3
•2.Hemoglobin >=8.0g/dL
•3.Platelet >=100,000/mm3
•4.AST <=100U/L, ALT <=100U/L
•5.T-Bilirubin <=2.0mg/dL
•6.Creatinine clearance >=50mL/min
•10)Possible to oral intake.
•11)Written informed consent.
•Confirmation before main registration
•12)Examination Laparoscopy does not show gross peritoneal dissemination
•13)Regarding the residual tumor after peritoneal lavage cytology and surgery, one of the following applies.
•1.Peritoneal lavage cytology was negative (CY0) and gross curative resection (R0-1) was performed.
•2.Peritoneal lavage cytology is positive (CY1) and macroscopic curative resection (R0-1) is considered possible.

•1)Simultaneously active double cancer.
•2)Severe complication (interstitial pneumonia, pulmonary fibrosis, uncontrollable diabetes, uncontrolled hypertension, heart failure, renal failure, cirrhosis, liver failure, etc.)
•3)Contraindication to tegafur, gimeracil, oteracil potassium(S-1), docetaxel hydrate(docetaxel), paclitaxel or oxaliplatin.
•4)Pregnancy, breast feeding or intention to become pregnant.
•5)Judged inappropriate for this trial for other reasons.

发起方

Ishigami Hironori