Randomized phase II trial of irinotecan(CPT-11) plus tegafur/uracil with oral leucovorin(UFT/LV) compared with FOLFIRI in patients with unresectable/recurrent colorectal cancer
- Conditions
- Patients with previously untreated and unresectable/recurrent colorectal cancer
- Registration Number
- JPRN-UMIN000000951
- Lead Sponsor
- Department of Surgery, School of Medicine, Keio University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 72
Not provided
1)with history of myocardial infarction, drug hypersensitivity within 6 months prior to the registration. 2) Prior ventral irradiation for colorectal cancer. 3)with active infection. 4)with intestinal paralysis, intestinal obstruction, interstitial pneumonitis or pulmonary fibrosis, uncontrolled diabetes mellitus, cardiac failure, renal failure, liver dysfunction, which disturb registration to this study. 5) Massive pleural or ascites that required drainage. 6)with brain metastasis. 7)with diarrhea. 8)with active double cancer. 9)patients receiving Flucytosine or Atazanabil. 10)with mental disorder which disturbs registration to this study. 11)pregnant or nursing women or women who like be pregnant. 12)men with partner willing to get pregnant. 13)patients receiving analgesic drug or steroids. 14)doctor's decision not to be registered to this study. In addition to the above-mention, patients who hope to use Bevacizumab together has to be checked about the following factors. 1)Urine dipstick for proteinuria should be <2+ 2)Patient with a past history of thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism. 3)Major surgical procedure, open biopsy, or clinically significant traumatic injury within 4 weeks. 4) History of gastrointestinal perforation, intestinal tract paralysis, or ileus within 1 year. 5) Long-term daily treatment with aspirin (>325 mg/day) 6) History of evidence of bleeding tendency or coagulopathy or defect of coagulation factor (INR>=1.5) or patient who taking anticoagulant agent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Step1 Toxicity Step2 Progression-free survival
- Secondary Outcome Measures
Name Time Method Step2 Response rate, toxicity, Time to treatment failure, overall survival