NIPH Clinical Trials Search

UMIN ID: C000000094

Registered date:30/08/2005

A phase II study of systemic chemotherapy with TS-1 and CDDP followed by surgery in advanced gastric cancer with extensive lymph node metastasis(JCOG0405)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedgastric neoplasm
Date of first enrollment2005/02/01
Target sample size50
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Preoperative chemotherapy with TS-1+CDDP followed by gastrectomy with D3 lymph node dissection


Primary OutcomeProportion of curative resection
Secondary Outcome3-year survival, proportion of completion of treatment, response rate, toxicities

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria
Exclude criteria1) Active multiple cancer 2) Probable pregnancy, and the period of lactation 3) Difficulty to join the trial due to psychosis or psychotic symptoms 4) Under treatment with systemic steroid 5) Under treatment with flucytosine, phenytoin, or warfarin 6) Allergy to iodine 7) Serious complications 8) Past history of myocardial infarction withoin 6 months 9) Not fit to the protocol treatment by the physicion's dicision

Related Information


public contact
Name Akira Tsuburaya, MD
Address 1-1-2 Nakao, Asahi-ku, Yokohama, 241-0815, JAPAN Japan
Affiliation JCOG0405 Coordinating Office Gastric Surgery Division, Kanagawa Cancer Center
scientific contact
Name Mitsuru Sasako, MD, PhD
Address 1-1 Mukogawacho, Nishinomiya, Hyogo, Japan Japan
Affiliation Hyogo College of Medicine Upper GI Surgery Division