Colorectal Cancer
Conditions
Interventions
FOLFOXIRI +/- bevacizumab (Until 12 course) 5-FU + levoforinate +/- bevacitumab (After 13 course) bevacizumab 5mg/Kg/bi-weekly Irinotecan 150mg/m2/bi-weekly Oxaliplatin 85mg/m2/bi-weekly Levofo
Sponsors
Japan Clinical Cancer Reseach Organization (JACCRO)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Histologically confirmed colorectal cancer. (2) KRAS mutant-type or RAS mutant-type. (3) Measurable lesion by RECIST (Ver.1.1). (4) No past history of chemotherapy. (5) Age; more than 20 years old and less than 76 years old. (6) ECOG Performance status 0-1 and in case of more than 71 years old must be PS 0. (7) Life expectancy of more than 3 months. (8) Patients have enough organ function for study treatment within 14 days before enrollment; 1) WBC>= 3,000/mm3, <12,000/mm3. 2) Neu>= 1,500/mm3. 3) PLT>= 100,000/mm3. 4) Hb>= 9.0g/dL. 5) Total bilirubin<= 1.5x ULN. 6) AST<= 2.5x ULN. 7) ALT<= 2.5x ULN. 8) Creatinine<= 1.5x ULN. 9) Proteinuria<= 1+. (9) Written informed consent.
Exclusion criteria
Exclusion criteria: (1) Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval. (2) Brain metastases. (3) Infectious disease. (4) Interstitial lung disease or pulmonary fibrosis. (5) Comorbidity or history of serious heart failure. (6) History of thromboembolic events. (7) Cerebrovascular disease. (8) History of hemoptysis/hematemesis. (9) Uncontrolled hypertension.(systolic BP>180mmHg, or diastolic BP>100mmHg) (10) Sensory alteration or paresthesia interfering with function. (11) Large quantity of pleural, abdominal or cardiac effusion. (12) Severe comorbidity (renal failure, liver failure, hypertension, etc) (13) Prior radiotherapy for primary and metastases leision. (14) Men/women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test. (15) History of severe allergy. (16) HBs-Ag(+), or HCV-Ab(+). (17) Administration of blood products/ G-CSF, and blood transfusion within 14 days. (18) Surgical procedure or such as skin-open biopy, trauma surgery, or other more intensive surgeries within 28 days. (19) Systemaic administration of antiplatelet drug or NSAIDs. (20) Diathesis of bleeding (history of hemoptysis, including cavitation and/or necrosis in lung metastasis confirmed by imaging), coagulopathy. (21) Active peptic ulcer. (22) History of gastrointestinal perforation within 1 year. (23) Unhealed traumatic bone fracture. (24) Uncontrolled diarrhea. (25) History of organ recipient . (26) Prior bevacizumab/Irinotecan/Oxaliplatin treatment.(Adjuvant therapy by Oxaliplatin is excluded) (27) Administration of atazanavir sulfate. (28) Jaundice. (29) Ileus or bowel obstruction. (30) Any other cases who are regarded as inadequate for study enrollment by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival Overall Survival Safety Early Tumor Shrinkage Deepness of Response Correlation between biomarkers and therapeutic effects and prognosis | — |
Countries
Japan
Contacts
Public ContactMasashi Fujii
Japan Clinical Cancer Reseach Organization (JACCRO) Research Office
Outcome results
None listed