Phase I/II Study of Chemoradiotherapy with Paclitaxel for Elderly Stage IB-III Esophageal Cancer (elderly PTX-RT Phase I/II ) - elderly PTX-RT (elderly PTX-RT Phase I/II)

Hamamoto Yasuo0 个研究点目标入组 74 人开始时间: 2019年3月15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 squamous cell carcinoma, adenosquamous carcinoma or basaloid cell carcinoma.
•2) Primary tumor located in thoracic esophagus. Second tumors in cervical or abdominal esophagus which is indicated for EMR/ESD are also eligible.
•3) Clinical stages IB, II or III based on the 7th UICC-TNM classification.
•4) Patients who are amenable to 60Gy radiation therapy.
•5) >=70 years old.
•i) >=70 and <80 year-old-patient, PS (ECOG) of 0 or 1, and Creatinine>=1.5mg/dl.
•ii) >=70 and <80 year-old-patient, PS (ECOG) of 2.
•iii) >=80 year-old-patient, PS (ECOG) of 0 and 1.
•7) Patients have measurable and/or non-measurable disease according to RECIST ver1.1.
•8) No prior treatment against esophageal cancer except for endoscopic resection.
•9) No prior chemotherapy and radiation therapy.
•10) Sufficient organ functions.
•i) Neutrophil >= 1500/mm3
•ii) WBC < 12000/mm3
•iii) Platelet >= 100000/mm3
•iv) T.Bil =< 1.5mg/dL
•v) AST =< 100IU/L
•vi) ALT =< 100IU/L
•11) Refused esophagectomy.
•12) Written informed consent.

•1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy.
•2) Infectious disease with systemic therapy indicated.
•3) Severe psychiatric disease.
•4) Continuous systemic steroid therapy.
•5) Poorly controlled diabetes mellitus.
•6) Severe pulmonary fibrosis or emphysema.
•7) Unstable angina pectoris, or history of myocardial infarction within three months.
•8) Other conditions not suitable for this study.

发起方

Hamamoto Yasuo