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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007252
Receipt No. 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

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Basic information
Public title XELOX plus PSK compared with XELOX as adjuvant treatment for StageIII colon cancer.
Acronym XELOX plus PSK compared with XELOX as adjuvant treatment for StageIII colon cancer.
Scientific Title XELOX plus PSK compared with XELOX as adjuvant treatment for StageIII colon cancer.
Scientific Title:Acronym XELOX plus PSK compared with XELOX as adjuvant treatment for StageIII colon cancer.
Region
Japan

Condition
Condition colon cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes peripheral neuropathy as adverse event frequency
Key secondary outcomes the time to the peripheral neuropathy as adverse event,rate of treatment accomplishment,tolerated dose, disease free survival time,other adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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).
Interventions/Control_2 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
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 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
Key exclusion 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
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kunihiko Wakamura
Organization Showa University Northern Yokohama Hospital
Division name Digestive Disease Center
Zip code
Address Chigasaki-Chuo 35-1, Tsuzuki-ku, Yokohama City, Kanagawa Prefecture, 224-8503
TEL 045-949-7000
Email wakamura92@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Kunihiko Wakamurav
Organization Showa University Northern Yokohama Hospital
Division name Digestive Disease Center
Zip code
Address Chigasaki-Chuo 35-1, Tsuzuki-ku, Yokohama City, Kanagawa Prefecture, 224-8503
TEL 045-949-7000
Homepage URL
Email wakamura92@hkg.odn.ne.jp

Sponsor
Institute Showa University Northern Yokohama Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2012 Year 02 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2012 Year 01 Month 23 Day
Date of IRB
Anticipated trial start date
2012 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 02 Month 09 Day
Last modified on
2017 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008430

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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