Safety and efficacy of postoperative adjuvant chemotherapy with L-OHP base regimen followed by UFT plus LV for resectable liver metastases fro m colorectal cancer. (LOFT trial ) - LOFT trial

Hatano Etsuro0 sites50 target enrollmentFebruary 13, 2020

Overview

No summary available.

Registry

who.int

Start Date

February 13, 2020

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Hatano Etsuro

•1\. Histlogically proven colorectal carcinoma. 2\. Curatively resected metastatic liver tumors of colorectal cancer. 3\. No extrahepatic metastasis. 4\. Within 4\-8 weeks from the date of liver resection. 5\. Age \>\= 20 years, Age \<\= 80 years 6\. The Eastern Cooperative Oncology Group(ECOG) Performance Status of 0\-1 7\. Cases that meet all the following criteria (Check all items using the test values of the latest within 14 days prior to entry). i.Neutrophil count \>\=1500/mm3 ii.Platelets\>\=100,000/mm3 iii.Hemoglobin \>\=9\.0g/dL iv. Total bilirubin \<\=1\.5g/dL v. AST, ALT, ALP \<\=2\.5ULN vi. Creatinine\<\=1\.5mg/dL 8\. Checked chest and abdominal CT within 30 days. 9\. Promised of more than 3 months survival 10\.Written informed consent.

•1\. Neurologic symptom due to cerebrovascular diseases. 2\. Cardiac diseases. 3\. Uncontrollable hypertension, Uncontrollable diabetes. 4\. Renal dysfunction. 5\. Uncontrollable gastrointestinal ulcer 6\. Prior hypersensitivity reaction to drugs used in this trial. 7\. Suspected of DPD Deficiency. 8\. Prior treatment with L\-OHP within 6 months. 9\. Treatment with MTX to RA. 10\. Uncontrollable infectious diseases. 11\. Uncontrollable diarrhea. 12\. Neuropathy \>\= Grade2 according to the CTCAE. 13\. Body fruid (ascites,pleural effusion.pericardiac effsion). 14\. Multiple malignancies to be treated within 5 years. 15\. Prior treatment with immunosuppressant and transplantation. 16\. Pregnant. 17\. Any other cases who are regarded as inadequate for study enrollment by investigators.