Unique ID issued by UMIN | UMIN000007252 |
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Receipt number | R000008430 |
Scientific Title | XELOX plus PSK compared with XELOX as adjuvant treatment for StageIII colon cancer. |
Date of disclosure of the study information | 2012/02/15 |
Last modified on | 2017/05/16 14:59:26 |
XELOX plus PSK compared with XELOX as adjuvant treatment for StageIII colon cancer.
XELOX plus PSK compared with XELOX as adjuvant treatment for StageIII colon cancer.
XELOX plus PSK compared with XELOX as adjuvant treatment for StageIII colon cancer.
XELOX plus PSK compared with XELOX as adjuvant treatment for StageIII colon cancer.
Japan |
colon cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
The purpose of this study is relieving the preventive effect of PSK for periperal neuropathy induced by XELOX therapy as post operative adjuvant therapy for StageIII colon cancer.
Safety,Efficacy
peripheral neuropathy as adverse event frequency
the time to the peripheral neuropathy as adverse event,rate of treatment accomplishment,tolerated dose, disease free survival time,other adverse events
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
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
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1.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
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
60
1st name | |
Middle name | |
Last name | Kunihiko Wakamura |
Showa University Northern Yokohama Hospital
Digestive Disease Center
Chigasaki-Chuo 35-1, Tsuzuki-ku, Yokohama City, Kanagawa Prefecture, 224-8503
045-949-7000
wakamura92@gmail.com
1st name | |
Middle name | |
Last name | Kunihiko Wakamurav |
Showa University Northern Yokohama Hospital
Digestive Disease Center
Chigasaki-Chuo 35-1, Tsuzuki-ku, Yokohama City, Kanagawa Prefecture, 224-8503
045-949-7000
wakamura92@hkg.odn.ne.jp
Showa University Northern Yokohama Hospital
None
Self funding
NO
2012 | Year | 02 | Month | 15 | Day |
Unpublished
No longer recruiting
2012 | Year | 01 | Month | 23 | Day |
2012 | Year | 02 | Month | 01 | Day |
2012 | Year | 02 | Month | 09 | Day |
2017 | Year | 05 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008430
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