Colorectal cancer
Conditions
Interventions
None listed
Sponsors
Nippon Medical Scool
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically diagnosed as colorectal cancer Having distant metastases, at least one of which is unresectable The longest axis of metastatic lesion is more than 2cm in diameter. First line chemotherapy for distant metastases has been completed Age between 20 and 80 years at the date of enrollment ECOG PS 0-1 Having measurable metastatic lesion. Oral intake is possible. Expected to survive for at least 3 months Preservation of major organ function with all of the following on examination within 2 weeks prior to enrollment White blood cell count: 3,500/mm3or higher Neutrophil count: 1,500/mm3 or higher Platelet count: 75,000/mm3 or higher Hemoglobin: 8.0g/dl or higher AST and ALT: Less than 2.5 times the upper limit of the institutional standard Total bilirubin: 1.5 mg/dl or less Creatinine: 1.5mg/dl or less Infection: No active infection suspected. Diarrhea, other non-hematological toxicity: less than Grade 1(Excluding hair loss, dysgeusia, hyperpigmentation, and symptoms associated with the primary disease) The patient's free written consent to participate in this study has been obtained after receiving sufficient explanation and understanding.
Exclusion criteria
Exclusion criteria: Having UGT1A1*6 homo, UGT1A1*28 homo, and UGT1A1*6*28 double hetero Contraindicated for anti-VEGF inhibitor. Previous treatment with irinotecan Previous treatment with ramucirumab or aflibercept History of severe drug hypersensitivity Pregnant women or women who may become pregnant. Men whose partners wish to become pregnant. Patients with serious complications (interstitial pneumonia or pulmonary fibrosis, renal failure, hepatic failure, uncontrolled diabetes mellitus, uncontrolled hypertension) Patients with pleural effusion or ascites requiring treatment Patients with peritoneal dissemination that is considered likely to cause intestinal obstruction. Active multiple cancers. Significant ECG abnormalities or clinically problematic heart disease (heart failure, myocardial infarction, angina pectoris, etc.) Having brain metastases. Patients with active multiple cancers with a disease-free interval of less than 5 years (cured basal cell carcinoma of the skin and cervical cancer, or gastric cancer, esophageal cancer, and colorectal pM cancer confirmed to be cured by endoscopic mucosal resection may be enrolled. FDG-PET scan is not necessary, but bone metastasis should not be detected. The physician in charge considers the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Association of RAS, BRAF, PIC3CA, and EGFR gene mutations in liquid biopsy with chemotherapy efficacy and prognosis of colorectal cancer | — |
Countries
Japan
Contacts
Public ContactHiromichi Sonoda
Nippon Medical School Hospital Department of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery
Outcome results
None listed