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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005286
Receipt No. R000006286
Scientific Title Preoperative immunochemotherapy with PSK for Stage II/III gastric and colorectal cancer to evaluate anti-tumor effect and transition of PSKinto tumor
Date of disclosure of the study information 2011/03/22
Last modified on 2016/08/09

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Basic information
Public title Preoperative immunochemotherapy with PSK for Stage II/III gastric and colorectal cancer to evaluate anti-tumor effect and transition of PSKinto tumor
Acronym Preoperative immunochemotherapy with PSK for Stage II/III gastric and colorectal cancer
Scientific Title Preoperative immunochemotherapy with PSK for Stage II/III gastric and colorectal cancer to evaluate anti-tumor effect and transition of PSKinto tumor
Scientific Title:Acronym Preoperative immunochemotherapy with PSK for Stage II/III gastric and colorectal cancer
Region
Japan

Condition
Condition Gastric and colorectal cancer with clinical stage II/III
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To elucidate anti- tumor immunity mechanism of PSK by analizing the ability of PSK to transfer into tumor and to induce antitumor immunity
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To examine transition of PSK and induce infiltration of cytotoxic T lymphocytes into primary tumor
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 TS-1 chemotherapy alone group
Interventions/Control_2 TS-1 with PSK group
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. Patients with clinically diagnosed as Stage II/III Gastric and colorectal cancer scheduled for surgical resection
2. Age between 20 and 80
3. No pretreatemnt for cancer
4. No redundant cancer
5. Patients who have retained well-torelated function of major organs including liver kidney and bone marrow
6. Performance Status 0~2
7, No severe coexisting desease
8. Informed and concent by written documant
Key exclusion criteria 1. Patients with active gastro-intestinal bleeding
2. Patients with massive ascites
3. Patients with active infection desease and ileus
4. Pregnant women
5. Patients with uncontrolled diabetes
6. Patients with ischemic heart desease
7. Patients with uncontrolled psychiatric disorder
8. Required administration of continual steroids
9. Histry of severe allergic desease
10. Pateints assesed inadequate case by principal investigator
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kosei Hirakawa
Organization Osaka City University Graduate School of Midicine
Division name Surgical Oncology
Zip code
Address 1-4-3, Asahimachi, Abenoku, Osaka
TEL 06-6645-3838
Email hiroakitan@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Tanaka
Organization Osaka City Osaka CIty University Graduate School
Division name Surgical Oncology
Zip code
Address 1-4-3, Asahimachi, Abenoku, Osaka
TEL 06-6645-3838
Homepage URL
Email hiroakitan@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Osaka City University Graduate School of MEdicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Kureha corporation
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 大阪市立大学大学院

Other administrative information
Date of disclosure of the study information
2011 Year 03 Month 22 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 Completed
Date of protocol fixation
2009 Year 09 Month 03 Day
Date of IRB
Anticipated trial start date
2010 Year 03 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
2013 Year 09 Month 30 Day
Date trial data considered complete
2013 Year 09 Month 30 Day
Date analysis concluded
2013 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2011 Year 03 Month 22 Day
Last modified on
2016 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006286

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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