UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010045 |
|---|---|
| Receipt number | 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 12:55:49 |
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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
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
sigefumi@yamaguchi-u.ac.jp
Sponsor or person
Institute
Department of Digestive Surgery and Surgical Oncology, Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011761
