Randomized Phase II/III Trial of Second Line Chemotherapy Comparing CPT-11 Monotherapy Versus S-1/CPT-11 Combination for S-1 Refractory Gastric Cancer
Standard chemotherapy for advanced gastric cancer (AGC) in the US is Cisplatin/5-FU (CF) or
docetaxel/CF (DCF), is in Europe epirubicin/CF (ECF) or epirubicin/oxaliplatin/ capecitabine
(EOX). Until 2006, there was no evidence of standard chemotherapy for AGC in Japan. In 2007,
by the results of JCOG9912 trial (5-FU alone vs. CPT-11/CDDP vs S-1) and SPIRITS trial (S-1
alone vs. S-1/CDDP), S-1/CDDP is regarded as a new standard regimen in Japan. In 2008, by
the results of TOP-002 trial (s-1 alone vs. S-1/CPT-11), S-1/CPT-11 could not show the
superiority to S-1 alone. One of the other phase III trials, JACCRO GC-03 trial (S-1 alone
vs. S-1/docetaxel, NCT00287768) is now ongoing. However, the position of CPT-11 in the
treatment of AGC will be regarded as a second-line.
In Japan there is a controversy for the treatment of S-1 refractory gastric cancer. The
controversy is continuing S-1 (like FOLFOX to FOLFIRI) or not as a second-line. After the
successful adjuvant S-1 results (ACTS-GC trial), the same problem will occur in the patients
who are recurrent from adjuvant S-1.
Then, we conducted a phase II/III trial of CPT-11 with or without S-1 in the treatment of
first-line S-1 refractory AGC.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
In phase II part, progressive disease rate will be measured for the safety. In phase III part, overall survival will be measured for the benefit of doublet.
Phase II: 6 weeks from treatment, Phase III: 2 years OS from randomization
Masashi Fujii, M.D.,PhD
Surugadai Nihon University Hospital
Japan: Ministry of Health, Labor and Welfare