advanced and/or recurrent colorectal cancer
Conditions
Interventions
XELOX(or FOLFOX)+Bevacizumab is given until disease progression.
Capecitabine (or LV5FU2)+Bevacizumab is given until disease progression. After progression, XELOX(or FOLFOX)+Bevacizumab is given unti
Sponsors
NPO Japan Southwest Oncology Research Support Organization
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histopathologically confirmed colorectal cancer 2) Advanced or recurrent colorectal cancer who are not candidate for curative resection (1)Patients with advanced colorectal cancer who had received no intervention expect surgical procedure(R0 surgery is not included). (2)Patients with recurrent colorectal cancer who have not been administered any therapy to the recurrent site. (six months after Adjuvant is not included). 3) Age of 20 years or older 4) ECOG performance status of 0-2 5) Presence of evaluable lesions as confi rmed by CT or MRI; no previous chemo therapy or radiotherapy 6) Life expectancy longer than 90 days 7) Oral administration is possible 8) Adequate organ function according to following laboratory values obtained within 14 days before enrolment (Data recorded nearest to the entry should be referred. And excluding patients who received blood transfusions or hematopoietic growth factors within 14 days before the laboratory test) Neu >=1,500/mm3 Pt >=10.0*10^4 /mm3 Hb >=8.0 g/dL T-bil <=2.0mg/dl AST and ALT <=100IU/l (Liver metastasis =< 200IU/l) sCr <=Institution standard value*1.5 Ccr >=30mL/min(Cockcroft-Gault) Proteinuria <=1+ PT- INR <3.0 9) Written informed consent after receiving explanation of planned treatments in the study
Exclusion criteria
Exclusion criteria: 1) History of active double cancer within 5 years 2) History of serious drug hypersensitivity or serious drug allergy. 3) Sever renal failure, hematologic toxicities, diarrhea, infections, massive pleural effusion, peritoneal fluid 4) Sever or uncontrolled complications (diabetes mellitus, High blood pressure, diarrhea, abnormality of the electrolyte). 5) Complication of cerebrovascular disease or the symptoms within 1 year 6) Bleeding tendency, coagulopathy (PT-INR>=3.0 within 1week prior to entry) 7) Thrombosis, thromboembolism, or receiving anticoagulant drugs (except aspirin under 325 mg/day) 8) Unhealed wound, or major surgical procedure within 28 days prior to enrollment in the study 9) Invasive assessment within 7 days prior to enrollment in the study excluding regular blood sampling, drip infusion, endoscopic examination, and central port 10) Aortic aneurysm and aortic dissection 11) Uncontrollable peptic ulcer 12) Concurrent or history of gastrointestinal perforation (within 1 year before enrollment) 13) Untreated traumatic bone fracture 14) Uncontrolled hypertension 15) Peripheral neuropathy >=Grade1 16) Patients who are pregnant, lactating, with child-bearing potential or have no intention to use contraceptive measures. 17) History of adverse events related to DPD deficiency 18) Mental disorders or central nervous system disease which could hinder treatments of the study 19) Patients who is judged by the investigator to be inappropriate for study participation for any reason. *Data recorded nearest to the entry should be referred.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Failure of Strategy | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free-survival,Overall survival, Quality of Life,Overall response rate (ORR),Time to treatment-failure, Duration of disease control, Safety | — |
Countries
Japan
Contacts
Public ContactMorihiro Fujita
NPO Japan Southwest Oncology Research Support Organization Study Secretariat
Outcome results
None listed