Previous OPTIMOX1 study investigated the use of oxaliplatin discontinuation and
reintroduction in a novel stop-and-go strategy. Previously untreated patients were randomly
assigned to either FOLFOX4 administered every 2 weeks until progression (arm A) or FOLFOX7
for 6 cycles, maintenance without oxaliplatin for 12 cycles, and reintroduction of FOLFOX7
for another 6 cycles (arm B). Data showed that there was no significant difference in median
progression-free survival (PFS) and overall survival (OS) between two arms. Furthermore, this
study showed lower Grade 3 neurotoxicity rate in arm B (17.9% vs 13.3%, P = 0.12).In order to
investigate the efficacy and feasibility of the novel "Stop and go" strategy in Chinese mCRC
patients, Prof. Shu Yongqian in JiangShu Province Hospital plans to conduct a randomized
controlled study to compare continuous FOLFOX4 vs. FOLFOX4 in a Stop-and-Go Fashion in 1st
Line mCRC patients. To avoid the high oxaliplatin dosage related neurotoxicity, FOLFOX4
regimen is chosen in this study.