A phase I study of the safety and efficacy of SOX therapy after preoperative chemoradiotherapy in lower advanced rectal cancer

Fujiwara Yoshiyuki0 个研究点目标入组 12 人开始时间: 2021年6月22日最近更新: 2023年10月17日

试验速览

暂无简介。

•1) Ages from 20 to 80 years old
•2) Stage II or III lower rectal cancer proven to be adenocarcinoma
•3) Eastern Cooperative Oncology Group performance status 0, 1
•4) Patients who underwent preoperative chemoradiation therapy for stage II or III lower advanced rectal cancer
•5) Patients with a S-1 dose intensity of 70% or higher during chemoradiation therapy
•6) White blood cell 3000/l or more, neutrophil 1500/l or more, hemoglobin 9.0g/dl or more, platelet 100,000 or more, AST/ALT less than twice the upper limit of normal, total bilirubin 1.5mg/dl or less, eGFR 60 ml/min/1.73m2 or more
•7) Patients who was obtained informed consent

•1) Previous radiation therapy for pelvis
•2) Involvement of adjacent organs
•3) Patients who have received chemotherapy for any malignancy within the past 6 months
•4) Patients with contraindications to S-1 or oxaliplatin
•5) Patients with serious complications (interstitial pneumonia, pulmonary fibrosis, uncontrolled diabetes, poorly controlled hypertension, heart failure, renal failure, liver cirrhosis, liver failure, etc.)
•6) Pregnant or lactating women and patients with the possibility (intent) of pregnancy
•7) Patients who participated in other clinical trials or clinical research and used unapproved or uninsured drugs within 3 months prior to enrollment
•8) Patients judged to be inappropriate for this study

发起方

Fujiwara Yoshiyuki