colorectal cancer
Conditions
Interventions
XELOX+ bevacizumab
Sponsors
Multicenter Study Group of Osaka (MCSGO), Colorectal Cancer Treatment Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Disease progression(PD) or difficult to continue for other reason after chemotherapy with Oxaliplatin containing regimen 2)Histological confirmation of colorectal cancer. 3) Advanced or recurrent colorectal cancer that is not amenable to curative resection. 4) Age: 20 years old or more. 5)Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. 6)With measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 7) Life expectancy greater than or equal to 3 months 8) Vital organ functions (listed below) are preserved within 14 days prior to entry 9) Patient of possible oral ingestion 10) Patient who doesn't have cerebral metastasis 11)Written informed consent 12) Other conditions suitable for this study
Exclusion criteria
Exclusion criteria: 1) Treatment with tegafur gimestat otastat potassium Within 7 days 2)History of the serious hypersensitivity for Fluorouracil , Levofolinate calcium,platinum or bevacizumab 3) Active multiple Primary cancer within 5 years 4) History of adverse events related to DPD loss 5) Uncontrolled diarrhea 6) Any surgical treatments oncluding skin-open biopsy,trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week 7)Complication of cerebrovascular disease or symptoms within 1 years 8) Administering antithrombotic drug within 10 days before enrollment 9)Need tobadministrate or having anti-plateles therapy(including Methotrexate aspirin and NSAIDS) 10)Evidence of bleeding diathesis or coagulopathy 11)Symptom of colorectal obstruction 12)uncontrolled complication of peptic ulcer 13)Current or previous (within the last 1 year) history of GI perforation 14)Renal failure to be treated,2+ or higher proteinuria within 2 weeks prior to entry 15)Uncontrolled Hypertension 16)Uncontrolled Infection 17)Pregnant women,possibly pregnant women,wishing to become pregnant,and nursing mothers 18)Man who doesn't practice birth control 19)Treatment history of Oxlplatin 20)Other conditions not suitable for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival Overall survival, 1-year survival rate Disease control rate Response time Safety Overall survival from first line Second progression free survival (Progression Free Survival from first line)Case who has bevacizumab treatment in Registered patient, | — |
Countries
Japan
Contacts
Public ContactTsunekazu Mizushima
Osaka University Graduate School of Medicine Department of Surgery
Outcome results
None listed