untreated and unresectable metastatic colorectal cancer
Conditions
Interventions
bevacizumab plus mFOLFOX6 therapy (first-line treatment) bevacizumab plus FOLFIRI therapy (second-line treatment)
Sponsors
Chubu Clinical Oncology Group (CCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed colorectal adenocarcinoma. 2. Unresectable metastatic disease. 3. Age 20 to 74 years. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 5. No previous chemotherapy for mCRC. 6. Bidimensionally measurable disease. 7. A life expectancy of at least 3 months 8. Written informed consent was obtained. 9. Adequate organ function.
Exclusion criteria
Exclusion criteria: 1. Previous history of severe drug-induced allergy 2. Brain metastasis 3. Cerebrovascular disease or its symptoms within 1 year. 4. Massive pleural effusion or ascites that required drainage. 5. History of active double cancer. 6. Previous history of thoromboembolitic disease, or necessity for antithrombotic drug. 7. Intestinal bleeding, ileus, bowel obstruction or uncontrolled peptic ulcer. 8. History of gastrointestinal perforation within 1 year. 9. Diathesis of bleeding (history of hemoptysis, including cavitation and/or necrosis in lung metastasis confirmed by imaging), coagulopathy. 10. Severe renal failure or urinary protein (more than 2+). 11. Uncontrolled severe complications (DM, hypertension, diarrhea, et al.). 12. Patient with symptomatic cardiovascular disease or asymptomatic disease but have been treated (>=Grade 2 according to NCI-CTCAE ver.4). History of myocardial infarction within a year. 13. Interstitial lung disease or pulmonary fibrosis. 14. Uncontrolled infection. 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. Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers. 17. Not appropriate for the study at the physician's assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2nd progression free survival (2nd PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS),overall survival (OS), response rate (ORR), disease control rate (DCR) and safty | — |
Countries
Japan
Contacts
Public ContactGoro Nakayama
Nagoya University Graduate School of Medicine Department of Gastroenterological Surgery
Outcome results
None listed