Colorectal cancer
Conditions
Interventions
SOX+BEV and IRIS+BEV sequential therapy
Sponsors
Niigata Colorectal Cancer Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologocally or cytologycally proved colorectal cancer(adenocarcinoma) 2)Unresectable advanced or recurrent colorectal cancer 3)RAS mutated type 4)Elder than 20years of age 5)ECOG performance status of 0-1 6)Measureable region evaluable according to the RECIST of Computed Tomography or Magnetic Reasonance Image or X-ray within 30days 7)Previously no chemotherapy and no radiation therapy in case of postoperative adjuvant chemotherapy passed more 180days 8)Possible oral intake 9)Laboratory data within 14days satisfies the following conditions 1.WBC => 3,000 /mm3, WBC=<12,000 /mm3 2.Neutrophil =>1,500 /mm3 3.Platelet => 100,000 /mm3 4.hemoglobin concentration => 9.0 g/dl 5.Total bilirubin <= 2.0 mg/dl 6.AST or ALT <= 100IU/L 7.AST or ALT <= 200IU/L with liver metastasis 8.Ccr>= 60mL/min with an actual measurement in 24hr. Without measurement to use Cockcroft-Gault Ccr=[(140-age)*body weight]/[72*serum cre](if female 0.85*) 9.Uric protein<=1+ 10.INR <=1.5 10)Life expectancy of at least 3months 11)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Presence of severe drug allergy 2)Pregnant patients 3)Active infection(>=38.0C) 4) Presence of severe complication(interstitial pneumonia or lung fibrosis, renal failure, liver failure, Poorly controlled diabetes mellitus poorly controlled hypertension 5) Remarkable ECG change or clinical heart disease (heart failure, AMI, angina) 6) Active gastric bleeding or gastric ulcer 7) Peripheral neuropathy 8) Severe diarrhea 9) Pleural effusion or ascites needed to treat 10) Gastrointestinal perforation in 6 months (without obstractive colorectal cancer) 11) Thromboembolism or cerebral infarction(without asymptomatic lacunar infarction ), pulmonary infraction, intestinal pneumonia 12) Operation within 28days (an exception of implanting central venous reservoir) 13) Congenital hemorrhagic diathesis or coagulopathy 14) Other active malignancies of DFS is within 5years (except for the case skin basal carcinoma and cervical cancer be cured or Stomach cancer, esophageal cancer, colorectal pM cancer that was confirmed cured by an endoscopic treatment) 15) Needed to dosage systemic steroid 16) Evaluated to be ineligible by a physician for other reasons 17) Hemoptysis( more than 2.5ml) 18) Contraindication of L-OHP ,CPT-11, BV , TS-1 19) Primary tumor with severe stenosis that an endoscope does not pass(Except for the case that constructed excision of the primary tumor or the artificial anus) 20) Peritoneum metastasis confirmed with an image.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Second progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| .Overall survival .Transfer ratio of 2nd line chemotherapy .Term of 1st line chemotherapy to 2nd line chemotherapy Each of the 1st line and 2nd line chemotherapy .Progression Free Survival: PFS .Time to treatment failure: TTF .Relative dose intensity: RDI .Response Rate .Frequency and Grade of Adverse Event .Term of hospitalization and frequency of visiting the hospital .Biomarker analysis | — |
Countries
Japan
Contacts
Public ContactYasuo Saijo
Niigata University Graduate School of Medical and Dental Sciences Department of Medical Oncology
Outcome results
None listed