A single center, phase 2 study to evaluate safety and efficacy of total neoadjuvant treatment of short course radiotherapy followed by cheMotherapy, capecitabine combined with oxaliplatin (CAPOX) for locally advanced rectal cancer - ENSEMBLE

Kagawa Yoshinori0 个研究点目标入组 27 人开始时间: 2021年1月19日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1)Written informed consent obtained
•2)Histological diagnosis of primary colorectal adenocarcinoma.
•3)No distance metastases with CT or PET
•4)Age >= 20 year old.
•5)ECOG 0 or 1. If Age >= 75 year old, ECOG 0.
•6)Treatment-naive patients with rectal cancer and clinically resectable rectal cancer located within 12cm from their anal verge.
•7)Clinical stage of cT3-4 N0 M0 or TanyN+M0
•8)Sufficient organ functions

•1. Received one of the following treatments,
•a. Extensive surgery within 4 weeks (excluding CV port)
•b. Any anti-cancer drug treatment within 4 weeks
•c. Irradiation within 4 weeks
•2. Have a complication or history of severe lung disease (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.).
•3. Cases with a colon stent for stenosis
•4. Cases with serious comorbidities (heart failure, renal failure, liver failure, hemorrhagic peptic ulcer, intestinal paralysis, intestinal obstruction, uncontrolled diabetes, etc.)
•5. Cases with active multiple cancers (simultaneous multiple cancers or metachronous multiple cancers with a disease-free period of 5 years or less). However, cancer in situ (carcinoma in situ) or lesions equivalent to intramucosal cancer that are cured by local treatment are not considered to be active multiple cancers.
•6. Pregnant women, lactating women, positive pregnancy tests, or no intention of contraception.
•7. Have Hbs antigen positive or HCV antibody positive
•8. Have a known human immunodeficiency virus (HIV) infection.
•9. In addition, the investigator or research coordinator judges that it is inappropriate for this study.

发起方

Kagawa Yoshinori