Phase II study of adjuvant chemotherapy with S-1 for cStage II and III thoracic esophageal cancer following neoadjuvant chemotherapy and curative esophagectomy - SUNSHINE Trial

Kitadani Junya0 个研究点目标入组 27 人开始时间: 2020年8月26日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•(1) Histologic confirmation of squamous cell carcinoma or adenocarcinoma
•orbasaloid carcinoma by endoscopic biopsy
•(2) Carcinoma are all localized in the thoracic esophagus
•(3) TMN clinical stage II, III
•(4) 20 years and older, under 80 years old
•(5) ECOG performance status 0-1
•(6) Patients who received more than 2 courses of docetaxel + cisplatin +
•S-1 (DCS therapy) as preoperative adjuvant chemotherapy
•(7) Patients who underwent curative esophagectomy (R0) with any surgical approach
•(8) Patients who can start adjuvant chemotherapy
•(9) Patients with normal oral intake
•(10) Laboratory values as follows
•1. Neutrophil count>=1,200/mm3
•2. Hemoglobin>=8.0 g/dL
•3. Platelet count>=75000/mm3
•4. Total bilirubin <=2.0 mg/dL
•5. AST<=100U/L
•6. ALT<=100 U/L
•7. Serum creatinine <=1.5 mg/dL
•8. Creatinine clearance>=40 mL/min
•(11) Informed consent has been obtained

•1)Patients with concurrent other primary cancer requiring treatment
•2)Patients whose recurrence has already been confirmed at the time of registration
•3)Pregnancy, possibly pregnant, or breast feeding
•4)Patients with psychosis or psychiatric symptoms
•5)Patients requiring systemic administration of steroids
•6)Positive HBs antigen
•7)Severe hypersensitivity to S-1
•8)Under treatment with flucytosine, phenytoin or warfarin
•9)Complication with interstitial pneumonia, pulmonary fibrosis, or severe emphysema
•10)Dementia
•11)Active infection
•12)History of myocardial infarction or unstable angina within 6 months before the date of registration
•13)Uncontrolled hypertension
•14)Uncontrolled diabetes mellitus
•15)Not recovering from postoperative complications by the time of registration
•16)Patients who are considered ineligible to enroll

发起方

Kitadani Junya