UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007252
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

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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 or person

Institute

Showa University Northern Yokohama Hospital

Institute

Department

Personal name



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

Value
https://center6.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