A Pilot Phase II Trial of Irinotecan Discontinuation and Reintroduction in Patients With Previously Untreated Advanced Colorectal Cancer
For medically-fit patients with advanced colorectal cancer, the current standard approach is
chemotherapy with FOLFIRI or FOLFOX. Although a strategy of using sequential 5-FU,
irinotecan and oxaliplatin has been thought to maximize overall survival in such patients,
significant toxicity remains a problem. It has been suggested feasible that chemotherapy can
be discontinued after 2-3 months and restart same treatment on progression in patients with
chemosensitive colorectal cancer. Thus we designed this pilot phase II study to evaluate the
feasibility and efficacy of first-line FOLFIRI discontinuation after initial 8 cycles and
reintroduction after progression.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate after FOLFIRI reintroduction
Se Hoon Park, MD
Principal Investigator
Gachon University Gil Medical Center, Incheon, Korea
Korea: Food and Drug Administration
GMO-GI-53
NCT00320320
April 2005
April 2007
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