The efficacy and safety of perioperative chemotherapy for locally advanced colorectal cancer. - The phase II study- - Perioperative chemotherapy for locally advanced colorectal cancer.

Tokuhara Katsuji0 个研究点目标入组 35 人开始时间: 2019年3月26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
•2) Investigator determines that the appropriate
•3) Histologically confirmed colorectal cancer(Excluding the appendix)
•4) RAS wild-type or mutant.
•5) With measurable lesion
•6) Irinotecan case of use UGT1A1 *6 *28 is a wild type or single hetero.
•7) Without chemotherapy history (Including the hepatic arterial infusion / radiation therapy). However, with regard to the post-operative adjuvant chemotherapy, to be registered if it passed more than 6 months from the end of treatment.
•8) Performance Status (ECOG) 0-2 (Possible outpatient treatment)
•9) Age over 20 years
•10) Survival period more than 3 months
•11) Adequate organ function (Inspection of within 14 days before)
•1. WBC: >=3000/mm3 and 12,000/mm3
•2. Neutrophil: >=1,500/mm3
•3. Platelet: >=100,000/mm3
•4. Hemoglobin: >=9.0g/dL
•5. T Bil: <=2.0mg/dL
•6. AST,ALT: <100IU/L
•7. Serum creatinine: <=1.5mg/dL
•12) With ability of oral intake

•1) Patients with severe drug allergy (hypersensitivity)
•2) Clinical problem infection
•3) Liver dysfunction (jaundice) / Severe renal dysfunction
•4) Uncontrolled high blood pressure, Diabetes, Hypercalcemia
•5) Severe lung disease (Interstitial pneumonia, Pulmonary fibrosis, Advanced emphysema, etc)
•6) Patient who need drainage of peritoneal, pleural or pericardial effusion.
•7) Brain metastases (Diarrhea a hindrance to daily life in the patient who has a colostomy)
•8) Diarrhea (watery stool)
•9) Hepatitis B / C virus-positive
•10) In addition, cases in which the investigator or the examination doctor judged it to be inappropriate for this study.

发起方

Tokuhara Katsuji