Trial of FOLF(HA)Iri Versus FOLFIRI in mCRC
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ABSTRACT: Trial design:
* Phase III, FOLFIRI versus FOLF(HA)iri (the FOLFIRI regimen with "Hyaluronic acid-Irinotecan" or "HA-Irinotecan") regimen.
* Patients with mCRC (metastatic colorectal cancer), 2nd/3rd line irinotecan naïve.
* Randomized 1:1, double-blinded, multi-centre, multi-national (Australia, Bulgaria, Poland, Serbia, Russia, Ukraine and the United Kingdom).
* Dosing regimen:
* Irinotecan (180 mg/m2) or HA-Irinotecan (180 mg/m2), IV, over 90 minutes, day 1 (in patients > 75 years of age, the irinotecan and HA-Irinotecan dose in must be reduced to 150 mg/m2).
* Leucovorin, 400 mg/m2, or levoleucovorin, 200 mg/m2, IV over 90 minutes with irinotecan.
* 5-fluorouracil (5-FU), 400 mg/m2 IV bolus day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion.
* Repeat every 2 weeks for 8 months.
* Patient accrual over approximately 12-14 months.
* Monitoring to 18 months post-randomization.
* 390 patients.
* Progression Free Survival (PFS) primary endpoint.
* Safety analysis on the initial 20 patients.
DISEASE(S): Metastatic Colorectal Cancer,Colorectal Neoplasms
PROVIDER: 2101890 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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