Advanced colorectal cancer
Conditions
Interventions
mFOLFOX6 + Bevacizumab or XELOX + Bevacizumab
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histopathologically confirmed colorectal adenocarcinoma which is a) Metastatic or locally advanced unresectable CRC with no prior therapy b) Recurrence after resection of the primary and/or metastatic lesion and not a candidate for re-resection, and; i) with no prior therapy other than surgery ii) with post-operative adjuvant chemotherapy in the following conditions; 1)Relapsed at 180 day or after from the last administration of FU (w/wo LV) 2)Relapsed at 366 days or after from the last administration of Oxaliplatin 3) Only use of FU (w/wo LV) and/or Oxaliplatin are permitted as post-operative adjuvant chemotherapy 2. ECOG PS of 0 or 1. 3.Have evaluable lesions; Following lesions are considered as not evaluable; Malignant effusion, bone metastasis, pulmonary lymphangites, abdominal masses that is not measurable by reproducible imaging and cystic lesions 4. Adequate hematologic, renal, and hepatic function as defined by required baseline laboratory parameters. a) WBC count>=3000/mm3 and <=12000mm3 b) Platelet count>=100000/mm3 c) Hemoglobin level>=9g/dl d) Total bilirubin<=1.5mg/dl e) AST and ALT<=100IU/L (or AST,ALT<=200IU/L with liver metastases) f) Serum creatinine<=1.5mg/dL g) INR<1.5 h) Urine dipstick 1+ or less 5. Expected survival>= 90 days 6. Written informed consent obtained from the patient
Exclusion criteria
Exclusion criteria: 1. Brain metastasis with symptoms. 2. Massive ascites, pleural effusion or pericardial effusions that need medical treatment. 3. Active another malignancies 4. Non-healing wound (excluding central venous port) 5. Major surgical procedure within 28 days prior to enroll in this study. (Minor surgical procedure within 14 days prior to enroll in this study.) 6. Other serious concomitant disease. a) intestinal obstruction b) History of arterial thromboembolic events such as unstable angina, myocardial infarction, and cerebrovascular accidents within 6 months. c) Clinically significant cardiovascular disease d) Severe pulmonary fibrosis, interstitial pneumonia or COPD on chest XP e) Uncontrollable hypertension f) Uncontrollable diabetes mellitus g) Active peptic ulcer h) Uncontrollable diarrhea i) Hemorrhagic Diathesis j) HIV infection 7. Regular use of corticosteroid. 8. Peripheral neuropathy>=Grade 1 at baseline. 9. Active local or systemic infectious disease. 10. History of serious hypersensitivity. 11. Blood tests positive for HBs antigen. 12. Uncontrollable severe mental disorder. 13. Pregnant or lactating female. 14. Judged inappropriate by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correlation between plasma VEGF-A level and Progression free survival time in CRC patients | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Correlation between plasma VEGF-A level and overall survival time in CRC patients 2) Correlation between plasma VEGF-A level and response rate to the chemotherapy in CRC patients 3) Searching predictive/prognostic biomarkers other than VEGF-A in CRC patients 4) OS, PFS, ORR and the safety of Fluorouracil+Oxaliplatin+Bevacizumab chemotherapy in CRC patients | — |
Countries
Japan
Contacts
Public ContactShinichiro Nakamura
West Japan Oncology Group WJOG datacenter
Outcome results
None listed