NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000007252

Registered date:15/02/2012

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

Basic Information

Recruitment status Complete: follow-up continuing
Health condition(s) or Problem(s) studiedcolon cancer
Date of first enrollment2012/02/01
Target sample size60
Countries of recruitmentJapan
Study typeInterventional
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 Outcomeperipheral neuropathy as adverse event frequency
Secondary Outcomethe 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 minimum20years-old
Age maximum80years-old
GenderMale and Female
Include criteria1.Patient with histological stage IIIa or IIIb cancer with primary colon adenocarcinoma. 2.Patient who has undergone curative surgery with no residual cancer. 3.Pretreatment criterion:patient who has not undergone preoperative cancer treatment(radiotherapy,chemotherapy or immunotherapy) 4.Patinet who is at leaset 20 years and below 80 years old. 5.Patient with performance status(PS)of0-1(according to Eastern Cooperative Oncology Group,ECOG). 6.Organ function(laboratory data):patient who satisfies the following conditions or data of laboratory tests conducted within 2 weeks prior to start of trial a)White blood cell count:>=4,000/mm3 and <=12,000/mm3 b)absolute neutrophil count:>=2,000/mm3 c)Platelet count:>=100,000/mm3 d)Hb:>=9.0g/dl e)Serum total bilirubin:<2.0mg/dl f)Serum AST and ALT:<100IU/l g)serum creatinine:<=1.1mg/dL(Male) <=0.7mg/dL(Female) and eCCr>=50mL/min h)Normal ECG 7.Patinet with capable of oral intake 8.Patinet who has receive an explanation of this study by assent documents,and has given written informed consent to participate in this study
Exclude criteria1.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

Contact

public contact
Name Kunihiko Wakamurav
Address Chigasaki-Chuo 35-1, Tsuzuki-ku, Yokohama City, Kanagawa Prefecture, 224-8503 Japan
Telephone 045-949-7000
E-mail wakamura92@hkg.odn.ne.jp
Affiliation Showa University Northern Yokohama Hospital Digestive Disease Center
scientific contact
Name Kunihiko Wakamura
Address Chigasaki-Chuo 35-1, Tsuzuki-ku, Yokohama City, Kanagawa Prefecture, 224-8503 Japan
Telephone 045-949-7000
E-mail wakamura92@gmail.com
Affiliation Showa University Northern Yokohama Hospital Digestive Disease Center