Colo-rectal cancer
Conditions
Interventions
Capecitabin is administered between day 1 and 14 orally followed by 7 days rest. Bevacizumab is administered 7.5mg/kg by intra-venous infusion on day 1. One course takes 3 weeks. After 1st-PD, 130mg
Sponsors
Osaka Gastrointestinal cancer chemotherapy Study Group(OGSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically proven colon cancer or rectal cancer 2)with lesions which can be estimated by RECIST criteria version 1.1 3)with unresectable factors 4)without any symptoms which influence to lives 5)age between 20 and 75 years old 6)PS : 0-2 7)without any prior chemotherapy except fluoro-pyrimidine over 6 months ago 8)with enough rest period after prior modality : a)More than 4 weeks of surgical treatment b)More than 4 weeks of hormone therapy or immunotherapy c)More than 4 weeks of cytokine or BMR 9)with good function of important organs a)WBC : 3,000/mm3 <= and <= 10,000/mm3 b)neutrophil : 1,500/mm3 <= c)Hemoglobin : 9.0g/dL <= d)Platelet : 100,000/mm3 <= e)AST/ALT : within 3 times of normal range of the hospital f)Total bilirubin : 1.2mg/dL >= g)s-Creatinine : 1.2mg/dL >= h)ALP : 300U/L >= i)Creatinine clearance >= 50mL/min male : [(140-age) x B.W.(kg)]/[(72 x s-crearinine(mg/dL)] female : [(140-age) x B.W.(kg) x 0.85]/[(72 x s-crearinine(mg/dL)] 10)patients expected more than 8 weeks survival 11)with written informed consent
Exclusion criteria
Exclusion criteria: 1)with symptoms due to brain metastasis 2)with uncontrollable diarrhea 3)with difficulty on oral intake due to intestinal paralysis or obstruction 4)with infectious disease or febrile condition 5)HBs Ag (+) 6)with severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema etc.) 7)with severe diseases (uncontrollable DM, heart failure severe than NYHA III, renal failure and/or hepatic failure) 8)pregnant and/or nursing women, or women who expect pregnancy 9)with metastatic meningitis, uncontrollable convulsion, and/or mental disorder 10)with a more than grade 1 neural disorder 11)with a condition intolerant to medicines in this regimen (5-FU, Xeloda, TS-1, Avastine or Erplat) 12)with a history of allergy against 5-Fu, Capecitabine or TS-1 13)with a history of some chemotherapy and/or therapy including a VEGF antagonist for unresectable advanced/recurrent colon cancer 14)with a history of embolism, brain infarction (except Lacuna infarction) or pulmonary infarction 15)under easy bleeding condition due to some diseases or medicines (except low dose aspirin) 16)with a history of thoracic surgery or abdominal surgery 28 days ago except reservoir surgery 17)with active wounds 18)with a history of bloody spit more than 2.5mL 19)any other patient whom the physician in charge of the study judges to be unsuitable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival between the start of treatment and Progression of second line treatment (1st +2nd PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival of 1st line treatment Response Rate Disease Control Rate Overall Survival Adverse Events (Incidence and Grades) Medicines with good response during overall treatment by KRAS status | — |
Countries
Japan
Contacts
Public ContactMotoki Yoshida
Chemotherapy Center Department of surgery
Outcome results
None listed