drugset

drugset / Trial / NCT05179889

Adjuvant mFOLFIRINOX for High-risk Stage III Colon Cancer

NCT05179889 ↗

Phase 2/3 Recruiting 308 enrolled Chungnam National University Hospital Boryung Pharmaceutical Co., Ltd · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

A multicenter, open labeled randomized, phase II trial comparing mFOLFIRINOX and mFOLFOX6 as adjuvant treatment for high risk stage III (pT4N1/2 or pTanyN2) colon cancer

Timeline

Start: 2021-07-06
Primary completion: 2028-07-05
Completion: 2031-03-15

Publications

Lee KH, Yang IJ, Ha GW, Lee J, Park YY, Lee SH, Lee JM, Bae JH, Park EJ, Kim H, Kim KY, An S, Kim IY, Kim JY. mFOLFIRINOX versus mFOLFOX 6 as adjuvant treatment for high-risk stage III colon cancer - the FROST trial: study protocol for a multicenter, randomized controlled, phase II trial. BMC Cancer. 2024 Mar 29;24(1):397. doi: 10.1186/s12885-024-11939-x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Irinotecan	Small molecule	150 mg/m2	Intravenous
Subject	fluorouracil	Small molecule	400 mg/m2	Intravenous
Subject	fluorouracil	Small molecule	1200 mg/m2	Intravenous
Background	Leucovorin	Small molecule	400 mg/m2	Intravenous
Background	Levoleucovorin	Unknown	200 mg/m2	Intravenous
Background	Oxaliplatin	Small molecule	85 mg/m2	Intravenous

Indications