1st line or 2nd line therapy for unresectable colorectal cancer
Conditions
Interventions
FOLFIRI + bevacizumab consisted of bevacizumab 5mg/kg as a 90-minute infusion, then, l-LV 200 mg/m2 as a 2-hour infusion, and irinotecan 150 mg/m2 given as a 90-minute infusion, followed by bolus FU 4
Sponsors
NPO T-CORE (Tohoku Clinical Oncology Research and Education Society)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The criteria for eligibility were histologically proven colorectal cancer of ; an age of 20 to 75 years; with an unresectable primary tumor or with one or more unresectable metatatic tumor(s); no previous treatment for primary cancer except for the initial colorectal resection for the primary lesion, or no previous treatment for recurrent cancer (recurrent within 6 months from the end of adjuvant chemotherapy after primary surgery, should be excluded) or one privious treatment by FOLFOX regimen ; with performance status (ECOG) 0 or 1; and adequate organ function (a leukocyte count of 3500 or more and 12,000 or less per cubic millimeter ; a platelet count of at least 100,000 per cubic millimeter; aspartate aminotransferase and alanine aminotransferase levels of 100 or less international unit per litter; a total bilirubin level of no more than 1.5 mg per deciliter; and a serum creatinine level of no more than 1.2 mg per deciliter; a serum creatinine clearance level of no less than 50 mililitter per minutes; with a written informed consent for this study
Exclusion criteria
Exclusion criteria: The exclusion criteria were previously abdominal radiotherapy; active double cancers, with complication of paralytic intestine, bowel obstraction (ileus), uncontrolled diabtes mellitus, uncontrolled hypertention, unstable angina pectoris, liver cirrhosis, interstitial pneumonitis, pulmonary fibrosis or high-grade pulmonary emphysema; previous history of herpersensitivity against S-1; massive pleural or peritoneal effusion; diarrhea, uncontrolled peptic ulcer; current or previous (within one year) history of GI perforation; primary or metastatic brain tumor by image examination; current or previous (within one year) history of cerebrovascular attach; symptomatic or asymptomatic but treated heart disease; any surgical treatmentsincluding skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks (except for a CV-port procedure one week or more earlier) or aspiration biopsy within one week; bleeding tendency, coagulation abnormality; anti-platelets therapy (including aspirin and NSAIDS) for chronic inflammatory disease such as rheumatoid arthritis; irinotecan used pevious adjuvant chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety | — |
Secondary
| Measure | Time frame |
|---|---|
| response rate and progression free survival (PFS) | — |
Countries
Japan
Contacts
Public ContactShunsuke Kato
NPO T-CORE (Tohoku Clinical Oncology Research and Education Society) Office
Outcome results
None listed