JCOG2204: A randomized phase II study to compare the pathological responses of neoadjuvant chemotherapy for type 4 or large type 3 gastric cancer: 5-FU, Oxaliplatin and Docetaxel (FLOT) versus Docetaxel, Oxaliplatin and S-1 (DOS) - SCIRRHOUS FLOT/DOS

OHASHI Manabu0 个研究点目标入组 76 人开始时间: 2023年7月14日最近更新: 2024年5月27日

适应症

试验速览

暂无简介。

•(1) Pathologically proven adenocarcinoma with endoscopic biopsy specimen.
•(2) The macroscopic tumor type is either Borrmann type 4 (linitis plastica) or large (>=8 cm) type 3.
•(3) No distant metastasis based on contrast-enhanced thoracic, abdominal, and pelvic CT.
•(4) No non-curable factors other than positive lavage cytology (CY1) or peritoneal dissemination localized around the stomach (P1a) were revealed in a staging laparoscopy before registration.
•(5) No esophageal invasion or an invasion of less than 2 cm.
•(6) No residual stomach cancer.
•(7) Ages between 18 and 79 years.
•(8) Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
•(9) No prior chemotherapy, radiotherapy, or immunotherapy for any malignancies.
•(10) No history of any surgical treatment for gastric cancer other than endoscopic mucosal resection.
•(11) No obvious hemorrhage nor gastrointestinal obstruction due to the primary tumor.
•(12) Sufficient oral intake.
•(13) Sufficient organ function as follows:
•i) Neutrophil >= 1,500/mm3
•ii) Hemoglobin >= 8.0 g/dL
•iii) Platelet >= 75,000/mm3
•iv) Total bilirubin <= 2.0 mg/dL
•v) AST <= 100 IU/L
•vi) ALT <= 100 IU/L
•vii) Creatinine clearance (CCr) >= 50 mL/min/body
•(14) Written informed consent.

•(1) Synchronous or metachronous (within 5 years) malignancies except for cancer with a 5-year relative survival rate of >= 95%, such as carcinoma in situ, intramucosal tumor, or early-stage cancers.
•(2) Infectious disease that needs systemic treatment.
•(3) Body temperature is 38 degrees centigrade or higher at registration.
•(4) Females during pregnancy, within 28 days of post parturition, or during lactation, or males who expect a partner's pregnancy.
•(5) Severe psychiatric disease affecting daily life.
•(6) Receiving continuous systemic corticosteroid or immunosuppressive treatment.
•(7) Under flucytosine, phenytoin, or warfarin treatments
•(8) History of unstable angina pectoris within 3 weeks or myocardial infarction within 6 months before registration.
•(9) Uncontrollable valvular heart disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy.
•(10) Uncontrollable hypertension.
•(11) Uncontrollable diabetes mellitus.
•(12) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema diagnosed by chest CT.

发起方

OHASHI Manabu