metastatic colorectal cancer
Conditions
Interventions
Biweekly FOLFOXIRI+Bevacizumab +Pegfilgrastim Bevacizumab 5mg/kg/ q2w Oxaliplatin 85mg/m2/ q2w Irinotecan 165mg/m2/ q2w l-LV 200mg/m2/ q2w 5FU-infusional 3,200mg/m2/ q2w Pegfilgrastim 3
Sponsors
Kyoto University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum and inoperable metastatic disease 2.RAS mutant type 3.No Previous chemotherapy for colorectal cancer except adjuvant treatment if terminated more than 6 months before the start of study treatment 4.Unresectable liver metastases 5.Presence of a measurable index lesion(RECIST v1.1) 6.Age: between 20 and 75 years 7.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1 at study entry (patients above 70 years of age are eligble if their ECOG PS score is 0) 8.Adequate organ functions 1)WBC;3,000-12,000/mm3 2)ANC: greater than or equql to 1,500/mm3 3)Platelet: greater than or equql to 100,000/mm3 4)Hb: greater than or equql to 9.0g/dl 5)T-bil:less than or equal to 1.5 times the upper limit of normal (ULN) 6)aspartate transaminase (AST) or alanine transaminase (ALT) levels less than or equal to 2.5 times the ULN 7)serum creatinine level less than or equal to 1.5 times the ULN 8)Proteinuria below Gr1 (in the case of 2+ in the test paper method, registration possible in the case of proteinuria 1g <24 hours) 9.Life expectancy of at least 3 months 10.Provided signed written informed consent. 11.UGT1A1 *6*28 wild type or single hetero 12.No extrahepatic metastasis, or it can be determined to be curative even if extrahepatic metastases (lung metastasis PUL1 etc.)
Exclusion criteria
Exclusion criteria: 1.Severe infection 2.Neuropathy >= Grade 2 according to the CTCAE 3.Prior hypersensitivity reaction to drugs useing in this trial 4.Dementia, altered mental status, or any psychiatric condition 5.Uncontrolled body fruid (ascites,pleural effusion.pericardiac effsion) 6.Severe stenotic primary lesion 7.Recieved radiotherapy to target lesion 8.Severe comorbidity (paralytic or mechanical bowel obstruction, interstitial pneumonia, pulmonary fobrosis, uncontrolable diabetes, heart failure,hypertension, renal failure, liver failure,thromboembolic disease, cerebrovascular disease, etc.) 9.Current or previous (within the last 1 year) history of GI perforation 10.HBs-Ag(+) 11.Any surgical treatments including skin-open biopsy, trauma surgery and other more intensive surgery except for CV-port procedure within 28 days 12.Active other malignant disease 13.Symptomatic brain metastasis 14.Uncontroled severe diarrhea 15.Past chemotherapy history by cytotoxic agent for other diseases except hormone agents and molecular target drugs 16.Women's pregnant or nursing, men/women who want to give birth or no intention to contraception 17.Any other cases who are regarded as inadequate for study enrollment by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR: overall response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS: progression free survival, safety, R0 resection rate, Pathological response rate, OS:Overall survival, Treatment completion rate, RDI: relative dose intensity, ETS:Early Tumor Shrinkage | — |
Countries
Japan
Contacts
Public ContactAkira Nozaki
NHO Kyoto Medical Center Department of Clinical Oncology
Outcome results
None listed