A prospective study to verify the effectiveness of a element supplement Elental for patients who are administered TS-1 after surgical resection of pancreatic cancer - Elental adjuvant S-1 trial

Toyama Hirochika0 个研究点目标入组 35 人开始时间: 2019年2月19日最近更新: 2023年11月20日

适应症

试验速览

The number of compatible cases was extremely small and could not be analyzed.

•Eligebility Criteria during hospital state
•1)patients 20 years old or more
•2)proven pancreatic cancer histlogecally
•3)confirmed by R0 or R1 surgery
•4)PS (ECOG) between 0 and 2
•5)wityout any prior chemotherapy and/or radiation therapy
•6)with good oral intake
•7)written informed consent to participate in this study
•8)without any severe diseases and with a good condition of important organs for administration of TS-1
•a)WBC >= 2,500/mm3
•b)neutrophil >= 1,200/mm3
•c)platelet >=75,000/mm3
•d)hemoglobin >= 8.0g/L
•e)total bilirubin <= 1.5mg/dL
•f)AST/ALT <= 100 IU/L
•g)Creatinin clearance >= 40ml/min
•CC by Cockcroft-Gault method is avilable

•Exclusion Criteria during hospital stay
•1)with active double cancer (*)
•*Simultaneous double cancer or sequential double cancer whose interstitial period is shorter than 5 years.
•Carcinoma in situ or cancers localized in membranous layer are not included to double cancer.
•Cancers removed by EMR/ESD are included.
•2)with a history of allergy against TS-1 and/or Elental
•3)with active infection diseases
•4)with uncontrollable hypertension
•5)with uncontrollable DM
•6)with severe heart diseases clinically
•7)with severe lung diseases (interstitial pneumonitis,pulmonary fibrosis, or pulmonary emphysema)
•8)with psychologic diseases and/or psychological symptpms
•9)women pregnant and/or nursing or women who like to be pregnant
•10)patient registered to the other study whose endpoints are same to This study.
•11)patients whom doctor decide not to register to this study

发起方

Toyama Hirochika