advanced colorectal cancer
Conditions
Interventions
capecitabine plus intermittent oxaliplatin (CapeOx) in combination with Bevacizumab: (CapeOx + Bevacizumab)x5 cycles followed by (Capecitabine + Bevacizumab )x5 cycles, followed by (CapeOx + Bevacizum
Sponsors
Surgical Oncology Association in Chiba (SOAC)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Written informed consent. (2)20 years old or more when received informed consent. (3)Eastern Cooperative Oncology Group (ECOG) Performance Status (PS):0-1. (4)Life expectancy estimated 3 months, and more. (5)Histological confirmation of colorectal cancer. (6)With estimative lesion observed in imaging or intraoperation within 28 days before registration. (measurable lesions in RECIST criteria [ver.1.1] is dispensable) (7)Patients with metastatic colorectal cancer who had recieved no previous therapy. Patients with advanced colorectal cancer who had received no intervention expect surgical procedure. Patients with recurrent colorectal cancer who have not been administered any therapy to the recurrent site. (8)Patients who received no previous chemotherapy i.Patients who administered curative resection for primary or metastatic site with perioperative chemotherapy is excluded. ii.Patients who received non-curative resection is included. iii.Previous treatment with oxaliplatin contained regimen is allowed if it is completed at least 6 months before registration. (9)Vital organ functions (listed below) are preserved within 14 days prior to entry. i.White blood cell count >= 3,000/mm3 ii.Neutrophils >= 1,500/mm3 iii.Platelets >= 100,000/mm3 iv.Hemoglobin >= 9.0 g/dL v.Total bilirubin <= upper limit of normal (ULN)*1.5 vi.AST and ALT <= upper limit of normal (ULN)*2.5 (<= ULN*5 in case of liver metastasis) vii.Serum creatinine <= upper limit of normal (ULN)*1.5 viii.Urinary protein <= grade1 (+1)
Exclusion criteria
Exclusion criteria: (1)History of the severe hypersensitivity for capecitabine, oxaliplatin or bevacizumab. (2)CNS metastases or brain cancer confirmed by imaging. (3)Cerebrovascular disease or its symptoms within 1 year. Prior abdominal irradiation for colorectal cancer. History of suspected complication of arterial thromboembolism such as cerebrovascular disease or experienced thromboembolism once within a year or twice bore. (4)History of gastrointestinal perforation within 1 year. (5)Synchronous malignant coelomic fluid that required drainage. (6)Uncontrolled peptic ulcer. (7)Uncontrolled diarrhea. (8)Uncontrolled infection. (9)Diathesis of bleeding (history of hemoptysis, including cavitation and/or necrosis in lung metastasis confirmed by imaging), coagulopathy or abnormality of coagulation factor as INR>=1.5. (10)Uncontrolled hypertension. (11)Necessity for antithrombotic drug or drugs affected to coagulation and fibrinolytic system within 14 days before enrollment(Expect for low-dose of aspirin). (12)History of active double cancer within 5 years. (13)Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers. (14)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. (15)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. (16)Not appropriate for the study at the physician's assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival (PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety time-to-treatment failure response rate 1 (RR 1) progression free survival 2 (PFS 2) response rate 2 (RR 2) resection rate in | — |
Countries
Japan
Contacts
Public ContactChihiro Kosugi and Toru Tezuka
Teikyo University Chiba Medical Center Department of Surgery
Outcome results
None listed