Unresectable metastatic or recurrent colorectal cancer
Conditions
Interventions
XELOX plus bevacizumab therapy Bevacizumab 7.5mg/kg day1 Oxaliplatin 130mg/m2 day1 Capecitabin 2000mg/m2/day day1-15
Sponsors
Chubu Clinical Oncology Group (CCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Histopathologically confirmed colorectal cancer (2)Unresectable advanced colorectal cancer patient who have failed prior oral fluoropyrimidine , irinotecan plus bevacizumab (3)Age of 20 years or older (4)ECOG performance status 0-1 (5)Measurable or evaluable disease (RECIST ver.1.1.) (6)Alife expectancy greater than 3 months (7)satisfactory oral feeding (8)Adequate organ function (9)Written informed concent
Exclusion criteria
Exclusion criteria: 1)Uncontrolled infection. 2)Patient with symptomatic cardiovascular disease or asymptomatic disease but have been treated 3)Previous history of thoromboembolitic disease,or necessity for antithrombotic drug. 4)Severe lung disease.(Interstitial lung disease or pulmonary fibrosis.) 5)Severe liver disease. 6)Severe renal failure. 7)Previous history of severe drug-induced allergy 8)Intestinal bleeding, ileus, bowel obstruction or uncontrolled peptic ulcer. 9)History of gastrointestinal perforation within 1 year. 10)Uncontrolled severe complications(DM, hypertension, diarrhea, et al.) 11)History of active double cancer. 12)Massive pleural effusion or ascites that required drainage. 13)Brain metastasis 14)Patients with psycho-neurological disease,central nervous system damage,cerebrovascular disorder 15)Patient receiving surgical procedure or such as skin-open biopsy, trauma surgery, or other more intensive surgeries within 4 weeks or aspiration biopsy within a week. 16)Patient with untreated traumatic bone fracture. 17)Diathesis of bleeding (history of hemoptysis,including cavitation and/or necrosis in lung metastasis confirmed by imaging),coagulopathy. 18) Systemic administration of antiplatelet drug 19)Administration of immunosuppressants associated with organ transplantation 20)Patient who have peripheral nerve disorder 21)Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers. 22)Previous history of severe side effects for fluoropyrimidine 23)Not appropriate for the study at the physician's assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;Over response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival, Duration of disease control, Time to treatment-failure, Overall survival, Safety | — |
Countries
Japan
Contacts
Public ContactMiyuki Aoki
Clinical Oncology Group(CCOG) Data Center
Outcome results
None listed