colorectal cancer
Conditions
Interventions
XELOX+BV regimen (Capecitabine, Oxaliplatin, Bevacizumab)
Sponsors
Epidemiological and Clinical Research Information Network (ECRIN)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)All patients provided written informed consent before initiation of study-related procedures. 2)over 75 years old at the informed consent. 3)Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 4)A life expectancy of more than 3 months. 5)Histologically confirmed colorectal cancer. 6)With measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) ver.1.1. (however, the patients with two or more and 5 mm or more lung metastasis is eligible) 7)No prior chemotherapy or first recurrence with no chemotherapy for recurrent lesion.(without receiving adjuvant chemotherapy by 5FU only) 8)Adequate function of vital organs, including normal hematopoietic function, normal liver function and normal renal function as evidenced by the following data within two weeks before registration: i.White blood cell count over 3000/mm3. ii.Neutrocyte count over 1500/mm3. iii.Platelet count over 100 000/mm3. iv.Hemoglobin over 9.0 g/dl v.Total bilirubin level, 1.5 times the institutional upper limit of normal. vi.Aspartate aminotransferase and alanine aminotransferase levels, 2.5 times the institutional upper limit of normal. vii.Serum creatinine level below the institutional upper limit of normal or over 50 ml/min.
Exclusion criteria
Exclusion criteria: 1)Uncontrolled pleural effusion or ascites. 2)Brain metastasis. 3)Other active malignancies or a history of other malignancies within the past 5 years. 4)Clinically problematic cerebrovascular disease or arterial thromboembolism, or history of cerebrovascular disease or arterial thromboembolism within the past 1 year. 5)Surgery, biopsy specimen with section or sutures within the past 4 weeks. Fine needle aspiration biopsy within 1 week. 6)Planning of surgery during the trial. 7)Clotting drug use within the past 10 days. 8)Bleeding tendency. 9)Uncontrolled peptic ulcer. 10)Perforation of the digestive tract or history of the perforation of the digestive tract within the past 6 months. 11)Untreated traumatic bone fracture. 12)Nephropathy that requires medication or transfusion or urine protein over +2 within 2 weeks examination. 13)Uncontrolled hypertension. 14)Uncontrolled diabetes mellitus. 15)Clinically problematic cardiac disease (grade 2 or more, based on Common Toxicity Criteria for Adverse Events [CTCAE] ver.4.0 within the past 12 months). 16)History of hypersensitivity against fluorouracil or platinum agents. 17)History of the adverse events related to dihydropyrimidine dehydrogenase deficiency against fluorinated pyrimidines. 18)Uncontrolled diarrhea. 19)Severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema etc.). 20)Organ transplant that requires any immunosuppressant. 21)Uncontrolled infection. 22)History of bevacizumab use. 23)Unable to intake orally. 24)Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity ORR; overall response rate TTF; time to treatment failure OS; overall survival | — |
Countries
Japan
Contacts
Public ContactTosio Otuji
Dongo Hospital Kenseikai Internal Medicine
Outcome results
None listed