The multidisciplinary approach to the development of precision medical systems for the treatment of high-risk rectal cancer: a phase II study

Yonsei University Health System, Severance Hospital0 个研究点目标入组 31 人开始时间: 待定最近更新: 2021年8月30日

试验速览

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•1. High-risk patients of rectal cancer on pretreatment MRI using the following risk stratification system
•? Location of the lower part of the tumor is measured below less than 10 cm on the anal verge and lower part of the tumor is located below the lower limit of the peritoneal reflection.
•? If there is more than one, classify as a high risk group
•? Positive CRM threatening:
•? 5mm ? Extramural depth
•? Positive EMVI.
•? Positive Lateral pelvic LN metastasis
•2. Between 19 and 80 years of age;
•3. Satisfactory performance status: ECOG?2
•4. American Society of Anesthesiologists (ASA) physical status classification system class I~III
•5. Adequate hematologic function: white blood cell(WBC) counts=4,000/mm3, neutrophils counts = 2,000/mm3, platelet counts = 1000,000/µL, hemoglobin = 9g/L;
•6. Adequate renal function: creatinine = 1.5×upper normal limit

•1. The evidenc of relapse of distant metastasis
•2. Receiving treatment of other anti-cancer drug or methods
•3. Patients have low compliance and are not able to complete the entire trial
•4. Presence of uncontrolled life-threatening diseases
•5. cT4 with infiltration of anterior organ on pretreatment MRI
•6. cT4 with infiltration of internal or external anal sphincter on pretreatment MRI

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