A randomized phase II trial to test the efficacy of intra-peritoneal paclitaxel for gastric cancer with high risk for the peritoneal metastasis (INPACT trial).
Owing to its peculiar pharmacological characteristics, paclitaxel attains substantial intra-peritoneal concentration for a prolonged period when delivered intra-peritoneally, and is active against peritoneal metastasis of ovarian cancer. It is also considered promising against disseminated gastric cancer. However, the fact that the intra-peritoneal paclitaxel has not been approved in Japan has rendered its evaluation by a formal clinical trial impossible. The authors designed a randomized phase II trial using the Kodo Iryo Hyoka system, a new system to legally test an yet unapproved mode of treatment. It is hoped that this trial will result in a breakthrough in the treatment of peritoneal carcinomatosis from gastric cancer.
Kodera
Yasuhiro
Y
Department of Surgery II, Nagoya University Graduate School of Medicine, 63 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan. ykodera@med.nagoya-u.ac.jp
Imano
Motohiro
M
Yoshikawa
Takaki
T
Takahashi
Naoto
N
Tsuburaya
Akira
A
Miyashita
Yumi
Y
Morita
Satoshi
S
Nakao
Akimasa
A
Sakamoto
Junichi
J
Sasako
Mitsuru
M
D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage*; D005240:Feasibility Studies; D006801:Humans; D007262:Infusions, Intravenous; D007263:Infusions, Parenteral; D007564:Japan; D017239:Paclitaxel / Q000008:administration & dosage*; D018579:Patient Selection; D010534:Peritoneal Neoplasms / Q000517:prevention & control* / Q000556:secondary; D012107:Research Design; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology
D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel