Phase II study evaluating the efficacy of personalized treatment for locally advanced rectal cancer

Miura Takuya0 个研究点目标入组 40 人开始时间: 2022年3月16日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) Histologically confirmed rectal adenocarcinoma.
•2) Tumor lower margin is located at rectum (RS, Ra, Rb, P).
•3) High-resolution MRI scan is available and any of the following factors are present.
•Lateral lymph node metastasis, positive CRM, cT4, positive EMVI.
•4) No distant metastasis.
•5) Eastern Cooperative Oncology Group performance status (PS) 0-1.
•6) Age at enrollment must be 20 years or older.
•7) Adequate hematological, hepatic, renal and metabolic function parameters.
•8) Written informed concent.

•1) Active multiple cancers (intraepithelial cancer is acceptable).
•2) Contraindications to MRI (pacemaker, cerebral artery clipping, etc.)
•3) Patients with myelosuppression (neutrophil count <1,500/mm3, platelet count <100,000/mm3).
•4) Patients with severe renal impairment (Creatinine Clearance <30mL/min).
•5) History of chemotherapy for the target disease.
•6) Prior radiation therapy in the pelvic region.
•7) Drug hypersensitivity to study medications.
•8) History of major surgery (implantable central venous reservoir, stoma construction is acceptable) within 28 days prior to enrollment.
•9) History of clinically serious cardiovascular disease (myocardial infarction, unstable angina, heart failure, stroke, pulmonary embolism, other thromboembolism, etc.) within 6 months prior to enrollment.
•10) Patients with serious complications (interstitial pneumonia or pulmonary fibrosis, liver failure, active infection, etc.).
•11) Pregnant women, lactating women, and men who may be or intend to become pregnant, or whose partners wish to become pregnant.
•12) Other patients who are judged by the study physician to be inappropriate for the safe conduct of this study.

发起方

Miura Takuya