XELOX plus PSK compared with XELOX as adjuvant treatment for StageIII colon cancer.

UMIN ID: UMIN000007252

Registered date:15/02/2012

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: colon cancer
• Date of first enrollment: 2012/02/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Group A(XELOX) Oxaliplatin is given intravenous for 2 hours on Day1 every 21 days and Capecitabine is taken on Day1-Day14 every 21 days.1 course takes 3 weeks.Treatment repeated 8 courses(for 24 weeks).
Group B(XELOX+PSK) XELOX therapy is the same as group A.PSK is given 3g/day in three divided doses for 24 weeks from the start of XELOX therapy

Outcome(s)

• Primary Outcome: peripheral neuropathy as adverse event frequency
• Secondary Outcome: the time to the peripheral neuropathy as adverse event,rate of treatment accomplishment,tolerated dose, disease free survival time,other adverse events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1.Patient with metachronous or synchronous cancer 2.Patient who requires continuous use of phenytoin or warfarin potassium 3.Patient who has experienced serious drug allergy over grade 3 in past 4.Patientwith serious complications including paralysis of intestine,ileus,interstitial pneumonitis,fibroid lung,uncontrollable diabetes mellitus,heart insufficiency,renal insufficiency or hepatic insufficiency 5.Patient who is pregnant during this study 6.Male patient who intends to make someone pregnant during study 7.Patient with HIV positive 8.patient who is judged to be inappropriate as subject to this study by the principal investigator or the doctors in charge

Related Information

• Primary Sponsor: Showa University Northern Yokohama Hospital
• Source(s) of Monetary Support: None