NIPH Clinical Trials Search

UMIN ID: C000000278

Registered date:09/11/2005

Neoadjuvant chemotherapy using the TXL and CDDP followed by surgery for advanced gastric cancer - Phase II

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedadvanced gastric cancer
Date of first enrollment2005/10/01
Target sample size50
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)This nepadjuvant chemotherapy (NAC) regimen is as follows: 80mg/m2 TXL and 25mg/m2 CDDP is administered on days 1, 8, 15 with a 1-week rest, and is totally administered between 2 and 4 courses. After NAC, patients undergo surgery. If patients have a pathological response or cytological response, they are submitted to the same postoperative chemotherapy regimen for totally 4 courses with NAC.


Primary Outcomepathorogical response rate for all eligibility population
Secondary Outcomethree year survival rate, pathorogical response rate for patients who completed the protocol treatment, the proportion of complete resection, the proportion of patients who completed the protocol treatment, response rate of neoadjuvant chemotherapy, adverse event

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum80years-old
GenderMale and Female
Include criteria
Exclude criteria1) Serious complications 2) Active multiple cancer 3) Obvious infection or acute inflammatory condition 4) Under treatment with systemic steroid 5) Probable pregnancy, and the period of lactation 6) Difficulty to join the trial due to psychosis or psychotic symptoms 7) Allergy to drugs containing Cremophor EL (including cyclosporin) 8) History of severe drug allergic reaction 9) History of alcoholic allergic reaction 10) Peripheral neuropathy 11) Not fit to the protocol treatment by the physicion's dicision

Related Information


public contact
Name Hiroko Fukushima
Address Japan
Telephone 075-752-1519
Affiliation Kyoto University Epidemiological & Clinical Research Information Management
scientific contact
Name Naoki Nagata
Address 1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu-shi, 807-8555, Japan Japan
Affiliation University of Occupational & Environment Health Department of Surgery I