Colorectal Cancer
Conditions
Sponsors
Surgical Oncology Association in Chiba (SOAC)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) patient with any of the fllowing (1) patient who is 20 years or older, and considered to be intorelant to irinotecan or oxaliplatin. (2) Patient who is 20 to 74 years old and with an ECOG Performance Status of 2 (3) Patient who is over 75 years old and with an ECOG Performance Status of 0 or 1 2) patient who has histologically or cytologically confirmed colorectal adenocarcinoma 3) patient who has unresectable primary tumor or with one or more unresectable metatatic tumor(s) 4) patient who has a treatment history of one or more regimens for metastatic colorectal cancer, and who is refractory or intolerant to them 5) patient who has at least one measurable lesion in imaging study 6) patient with ability to tolerate oral drug administration 7) patient who has adequate main organ functions in tests within 14 days before enrollment (1) WBC >= 3500/mm3 (2) neutrophil count >=1,500/mm3 (3) platelet count >=75,000/mm3 (4) haemoglobin concentorarion >=9.0 g/dL (5) AST, ALT <= 2.5x Upper limit of normal (<= 5.0x when liver metastasis exists) (6) serum total bilirubin level <=1.5 mg/dL (<= 2.0 when liver metastasis exists) (7) serum creatinine <=1.5 mg/dL (8) no active infection (9) Peripheral neuropathy<=grade2 (10) Diarrhea and NonHaematotoxicity =<grade1 8) gave written informed consent
Exclusion criteria
Exclusion criteria: 1) contraindications for TAS-102 and BEvacizumab 2) previously received chemotherapy with TAS-102 3) severe drug allergy 4) pregnant woman or Possibility of the pregnant woman. male patient who hoping partner's pregnancy. 5) patient who has important clinical complications(symptomatic unstable ischemic heart disease, arrhythmia, acute myocardial infarction within 6 months, liver cirrhosis, renal failure, active gastrointestinal ulcer, ileus, uncontrolled diabetes, uncontrolled hypertension, etc.) 6) have pleural effusion and ascitic fluid with the treatment 7) previous hemoptysis (over 25ml of fresh blood) 8) current or previous (within the last 6 months) history of GI perforation 9) patient with thrombosis (within the last 6 months) 10) patient with bleeding tendency 11) synchronous or metachronous multiple malignancy within the last 5 year disease free interval 12) dicision of unsuitable for this study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Overall Survival 2)Time to Treatment Failure 3)Response Rate 4)Disease control rate 5)Adverse events 6)Relation between RAS status and effectiveness of chemotherapy 7)Relation between location of tumor and effectiveness of chemotherapy 8)Relation between the timing when chemotherapy started and effectiveness of chemotherapy | — |
Countries
Japan
Contacts
Public ContactHideaki Miyauchi
Chiba University Department of frontier surgery
Outcome results
None listed