Phase II study of FOLFIRI+Ramucirumab with early recurrent colorectal cancer refractory to adjuvant chemotherapy with oxaliplatin / fluoropyrimidine(RAINCLOUD)
- Conditions
- Colorectal Cancer
- Registration Number
- JPRN-UMIN000028677
- Lead Sponsor
- MCSGO: Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 48
Not provided
1) Has simultaneous or metachronous 2) Has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders 3) Has an uncontrolled intercurrent illness 4) Has experienced any arterial thrombotic or arterial thromboembolic events 5) Receiving chronic antiplatelet therapy, including aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), dipyridamole or clopidogrel, or similar agents. Once-daily aspirin use (maximum dose 325 mg/day) is permitted 6) Has known (currently or in the past) leptomeningeal disease or brain metastases or uncontrolled spinal cord compression 7) Has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy 8) Either of HIV-1 antibody, HIV-2 antibody or HBs antigen is positive 9) The patient who is HBs antibody or HBc antibody positive and HBV-DNA positive 10) Has received a prior autologous or allogeneic organ or transplantation 11) Has undergone major surgery within 28 days prior to randomization or subcutaneous venous access device placement within 7 days prior to randomization 12) Has had a serious nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization 13) Has an elective or planned major surgery to be performed during the course of the trial 14) Has an acute or subacute bowel obstruction or history of chronic diarrhea which is considered clinically significant in the opinion of the investigator 15) Has experienced a Grade 3 or higher bleeding event within 3 months prior to randomization 16) Has either peptic ulcer disease associated with a bleeding event, or known active diverticulitis 17) Has a known history or clinical evidence of Gilberts Syndrome, or is known to have any of the following genotypes: UGT1A1*6/*6, UGT1A1*6/*28, UGT1A1*28/*28 18) The patient desires to have children. 19) The patient whose participation is in the trial is inappropriate by the doctor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS)
- Secondary Outcome Measures
Name Time Method Overall Survival (OS), Time to treatment failure (TTF), Response Rate (RR), Disease Control Rate (DCR), Adverse Events