A Phase III Study to Compare the Efficacy and Safety of Paclitaxel Versus Irinotecan in Patients with Metastatic or Recurrent Gastric Cancer Who Failed in First‐line Therapy (KCSG ST10‐01)

Lessons Learned. Irinotecan could not be proven noninferior to paclitaxel as a second‐line treatment for patients with metastatic or recurrent gastric cancer. The failure to demonstrate noninferiority may have been a result of insufficient patient enrollment. Both agents were tolerable but showed different toxicity profiles.