Unresectable metastatic or recurrent colorectal cancer
Conditions
Interventions
(1)Initial therapy : SOX+bevacizumab therapy Bev : 7.5 mg/kg (90 min) L-OHP : 130 mg/m2 (120 min) S-1 : 80 - 120 mg/day (Day1-15) (2)Maintenance therapy : S-1+bevacizumab therapy Bev : 7.5
Sponsors
Chubu Clinical Oncology Group
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) Unresectable advanced colorectal cancer patient who have received no treatment without operation. (9) Reccurent colorectal cancer patient who have received no treatment for reccurence. (10) Adequate organ function.
Exclusion criteria
Exclusion criteria: 1) Previous history of severe drug-induced allergy. 2) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers, and man who wish to become his partner pregnancy. 3) Uncontrolled infection. 4) Uncontrolled severe complications (Interstitial lung disease, pulmonary fibrosis, renal failure, liver failure, DM, hypertension, et al.). 5) Patient with symptomatic cardiovascular disease or asymptomatic disease. 6) Patient who have peripheral nerve disorder. 7) Patient who have severe diarrhea. 8) Massive pleural effusion or ascites that required drainage. 9) Brain metastasis 10) History of Interstitial lung disease. 11) History of active double cancer. 12) Systemic administration of steroid. 13) Contraindication of S-1, L-OHP, Bevacizumab. 14) Not appropriate for the study at the physician's assessment. 15) Patient receiving surgical procedure within 28days. 16) History of gastrointestinal perforation within 6 months. 17) Patient who have gastrointestinal ulcer or bleeding. 18) Diathesis of bleeding or coagulopathy. 19) History of thoromboembolitic disease. 20) Patient with untreated traumatic bone fracture. 21) Systemic administration of antiplatelet drug, aspirin, and NSAIDS. 22) History of hemoptysis. 23) Colorectal cancer with obstruction. 24) Peritoneum dissemination confirmed by imaging
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DDC ; Duration of disease control) | — |
Secondary
| Measure | Time frame |
|---|---|
| TTF;Time to treatment-failure, PFS;Progression free-survival, OS;Overall survival, RR;Response rate, Reintroduction rate of SOX+bavacizumab therapy, safety | — |
Countries
Japan
Contacts
Public ContactMiyuki Aoki
Chubu Clinical Oncology Group(CCOG) Data center
Outcome results
None listed