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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010045
Receipt No. R000011761
Scientific Title Clinical trial to research a novel biomarker of PSK responders in patients with colorectal cancer
Date of disclosure of the study information 2013/02/14
Last modified on 2013/09/09

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Basic information
Public title Clinical trial to research a novel biomarker of PSK responders in patients with colorectal cancer
Acronym Clinical trial to research a novel biomarker of PSK responders in patients with colorectal cancer
Scientific Title Clinical trial to research a novel biomarker of PSK responders in patients with colorectal cancer
Scientific Title:Acronym Clinical trial to research a novel biomarker of PSK responders in patients with colorectal cancer
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Patients with Stage II/III colorectal cancer received adjuvant immnochemotherapy after curative resection using UFT (Stage II) or UFT/LV (Stage III) combined with PSK for 1 year. The purpose of this study is to search the predictive parameters of PSK responder in patients with colorectal cancer according to the polymorphisms of cytokine promotor.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 3 years disease free survival
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 1)Curative resection
2)UFT (Stage II) or UFT/LV (Stage III) combined with PSK for 1 year
Interventions/Control_2
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)Histologically proven adenocarcinoma of colon cancer.
2)Patients with Stage II, III and recieved curative resection.
3)No prior radiotherapy, chemotherapy.
4)Age of 20 years or older, 79 years or younger.
5)ECOG Performance status:0-2.
6)Adequate organ functions:
without watery diarrhea
WBC >=3000/mm3,
platelets >=100,000/mm3,
AST(GOT)/ALT(GPT) <=100IU/L,
total bilirubin <=2.0mg/dL,
creatinine <=UNL.
7)Written informed consent.
Key exclusion criteria 1)Patients with non-curative resection.
2)Patients with anal canal cancer.
3)Patients with GI stricture.
4)A large amount of pleural effusion or peritoneal fluid.
5)Infection
6)Active synchronous malignancy.
7)Pregnant females, possibly pregnant
females, females wishing to become pregnant and nursing mothers.
8)Severe complications, such as uncontrolled diabetes mellitus.
9)Severe complications, such as heart failure.
10)Severe mental disorders.
11)Patients under treatment with steroid.
12)Other patients who are unfit for the study as determined by the attending physician.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaaki Oka
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Digestive Surgery and Surgical Oncology
Zip code
Address 1-1-1 Minamikokushi, Ube, Yamaguchi 755-8505, Japan
TEL 0836-22-2264
Email sigefumi@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigefumi Yoshino
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Digestive Surgery and Surgical Oncology
Zip code
Address 1-1-1 Minamikokushi, Ube, Yamaguchi 755-8505, Japan
TEL 0836-22-2264
Homepage URL
Email sigefumi@yamaguchi-u.ac.jp

Sponsor
Institute Department of Digestive Surgery and Surgical Oncology, Yamaguchi University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Digestive Surgery and Surgical Oncology, Yamaguchi University Graduate School of Medicine
Organization
Division
Category of Funding Organization Other
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
2013 Year 02 Month 14 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2007 Year 04 Month 25 Day
Date of IRB
Anticipated trial start date
2007 Year 08 Month 01 Day
Last follow-up date
2013 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 02 Month 14 Day
Last modified on
2013 Year 09 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011761

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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