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

UMIN ID: C000000278

Registered date:09/11/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: advanced gastric cancer
• Date of first enrollment: 2005/10/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional
• 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.

Outcome(s)

• Primary Outcome: pathorogical response rate for all eligibility population
• Secondary Outcome: three 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 minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1) 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

• Primary Sponsor: TC therapy for gastric cancer study group
• Source(s) of Monetary Support: Epidemiological & Clinical Research Information Management