Colorectal cancer
Conditions
Interventions
(1)Initial therapy : XELOX+bevacizumab therapy (2)Maintenance therapy : capecitabine+bevacizumab therapy (3)Reintroduced therapy : XELOX+bevacizumab therapy
Sponsors
Chubu Clinical Oncology Group (CCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Histopathologically confirmed colorectal cancer. (2) Written informed consent. (3) Age of 20 years or older. (4) ECOG performance status 0-1. (5) Life expectancy greater than 3 months. (6) Measurable or evaluable disease (RECIST ver.1.1.). (7) Untreated colorectal cancer. (8) 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 |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate, Overall survival, Duration of disease control, Reintroduction rate of XELOX+bavacizumab therapy, Safety | — |
Countries
Japan
Contacts
Public ContactMiyuki Aoki
Chubu Clinical Oncology Group (CCOG) Data Center
Outcome results
None listed