drugset / Trial / NCT00316745
IRIS Followed by mFOLFOX6 or the Reverse Sequence in Advanced Colorectal Cancer
Phase 3
Suspended
200 enrolled
Hokkaido Gastrointestinal Cancer Study Group
Hokkaido University Hospital · collab
RandomizedCrossoverOpen-labelTreatment
Summary
This randomized phase III study compares safety and efficacy of two sequence arms in advanced colorectal cancer: irinotecan and S-1 (IRIS) followed by oxaliplatin containing regimen (arm A), or l-leucovorin (l-LV), 5-FU and oxaliplatin (mFOLFOX6) followed by irinotecan containing regimen (arm B).
Timeline
- Start
- 2006-04
- Primary completion
- —
- Completion
- 2009-03
Outcome
Outcome not reported
Stopped: “Because of approval of Bevacizumab, it was difficult to perform clinical study in 1st line setting.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irinotecan | Small molecule | 100 mg/m2 | Intravenous |
| Comparator | L-Plat | Unknown | 85 mg/m2 | — |
| Comparator | Levoleucovorin | Unknown | 200 mg/m2 | — |
| Subject | TS-1 | Small molecule | — | Oral |
| Comparator | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |
| Comparator | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |