colorectal cancer
Conditions
Interventions
Second-line treatment with FOLFIRI plus panitumumab after failure of the first-line treatment with FOLFOX plus panitumumab for advanced and/or recurrent RAS wild-type colorectal cancer with special r
Sponsors
NPO Epidemiological and Clinical Research Information Network(ECRIN)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically-confirmed inoperable colorectal adenocarcinoma 2) Age more than 20 years 3) ECOG performance status of 0-2 4) Written informed consent prior to study-specific screening procedures 5) Life expectancy of at least 90 days 6) Withdrawal from the first-line chemotherapy with FOLFOX + panitumumab for RAS wild-type advanced or metastatic colorectal cancer due to intolerable toxicity or progressive disease 7) Adequate organ function
Exclusion criteria
Exclusion criteria: 1) History of other malignancy with a disease-free interval <5 years 2) With massive pleural effusion or ascites requiring intervention 3) Radiological evidence of brain tumor or brain metastases 4) Active infection including hepatitis 5) Any of the following complication: i) Gastrointestinal bleeding or gastrointestinal obstruction ii) Symptomatic heart disease iii) Interstitial pneumonia or pulmonary fibrosis iv) Uncontrolled diabetes mellitus v) Uncontrolled diarrhea 6) Any of the following medical history: i) Myocardial infarction ii) Serious hypersensitivity iii) History of adverse reaction to fluoropyrimidines iv) Previous treatment with irinotecan hydrochloride v) Current treatment with atazanavir sulfate vi) Previous treatment with tegafur, gimeracil, and oteracil potassium within seven days before enrollment vii) Pregnant and lactating females viii) Requires continuous treatment with systemic steroids ix) Psychiatric disability x) unsuitable for participation in the study xi) History of pulmonary hemorrhage/hemoptysis more than Grade 2 xii) History of laparotomy, thoracotomy, or intestinal resection within 28 days xiii) Unhealed wound xiv) Current or recent (within 1 year) thromboembolism or cerebrovascular disease xv) Currently receiving or requires anticoagulation therapy (more than 325 mg/day of aspirin) xvi) Bleeding diathesis, coagulopathy, or coagulation factor abnormality (INR more than 1.5 within 14 days before enrollment)xvii) Uncontrolled hypertension xviii) Urine dipstick for proteinuria more than +2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month progression-free survival (PFS) rate * | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS) Progression-free survival (PFS)** Time to treatment failure (TTF) Overall response rate (ORR) Disease control rate (DCR) Relative dose intensity (RDI) Safety and tolerability Gene mutation status | — |
Countries
Japan
Contacts
Public ContactYumi Miyashita
NPO Epidemiological and Clinical Research Information Network (ECRIN) Okazaki Office
Outcome results
None listed