UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005286 |
|---|---|
| Receipt number | 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 13:11:32 |
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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
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
hiroakitan@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006286
