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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002919
Receipt No. R000003385
Scientific Title An exploratory clinical trial of immunotherapy before surgery in stomach cancer case
Date of disclosure of the study information 2010/01/01
Last modified on 2009/12/07

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Basic information
Public title An exploratory clinical trial of immunotherapy before surgery in stomach cancer case
Acronym An exploratory clinical trial of immunotherapy before surgery in stomach cancer case
Scientific Title An exploratory clinical trial of immunotherapy before surgery in stomach cancer case
Scientific Title:Acronym An exploratory clinical trial of immunotherapy before surgery in stomach cancer case
Region
Japan

Condition
Condition stage I-III stomach cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Surgical stress induces inflammatory reaction and immunosuppression, which increase IL-6, inflammatory cytokine, or IL-10, anti-inflammatory cytokine, and decrease NK cell activity. It is investigated that need of perioperative immunomodulation in immunosuppressive patient as elderly. PSK is immunomodulator and modulate cytokines. In this study, we investigate whether PSK administration before surgery in stage I-III stomach cancer improve change of immune parameter as cytokines and perioperative infections.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Immunosuppressive parameter(IL-6, IL-10, TGF-beta)
Each parameter is measured to the following timing.
Before PSK administration before surgery
After PSK administration before surgery
Within 3 days after surgery
3 weeks after surgery
Key secondary outcomes Incidence of Surgical Site Infections
Surgical stress marker (MCP-1; Monocyte Chemoattractant Protein-1)
Serum albumin
Perioperative changes of CRP
Withdrawal rate of clinical path
Period of hospitalization

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation YES
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Control group
Interventions/Control_2 PSK before surgery group
3 times per day (3g)
2 weeks p.o. daily
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
60 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1.Stage I-III stomach cancer before surgery
2.60<=age<80 when get consent
3.Patient be scheduled surgery
4.Patient can take PSK 2 weeks before surgery
5.Patient didn't treated cancer therapy (radiation, chemotherapy, immunotherapy)
6.Patient has not double cancer
7.Patient has not severe disorder with renal function, hepatic function, bone-marrow function and maintain following function of main organ (laboratory data is before surgery and last data within 2 weeks before surgery)
Digestive tract function: patient has not diarrhea
White blood cell count: >=4000/mm3 and <12,000/mm3
Neutrophil count: >=2000/mm3
Thrombocyte count: >=100,000/mm3
Hemoglobin content: >=9.0g/dL
Serum GOT and GPT: less than 100IU/L
Serum total bilirubin: less than 1.5mg/dL
Serum creatinine: less than 1.5mg/dL
8.Performance status is 0-2 (ECOG)
9.Patient has not severe complication (myelosuppression, diarrhea, infection and so on)
10.Patient can tolerate this trial and get consent in writing
Key exclusion criteria 1.Fresh bleed from gastrointestinal tract
2.Body cavity fluid accumulation
3.Infection, intestinal tract paralysis, intestinal obstruction
4.Pregnant patient
5.Insulin treatment or uncontrolled diabate patient
6.Patient with a history of ischemic cardiac disease
7.Insanity, psychological symptom patient
8.Stable dose of steroid patient
9.Patient with a history of severe drug allergies
10.Advancing infection patient
11.Organ failure patient
And patient be disqualified as target by doctor
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiyuki Sasaki
Organization JIKEI UNIVERSITY SCHOOL OF MEDICINE
Division name DEPARTMENT OF SURGERY
Zip code
Address 3-19-18, Nishi-Shinbashi, Minato-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization JIKEI UNIVERSITY SCHOOL OF MEDICINE
Division name DEPARTMENT OF SURGERY
Zip code
Address 3-19-18, Nishi-Shinbashi, Minato-ku, Tokyo
TEL
Homepage URL
Email

Sponsor
Institute JIKEI UNIVERSITY SCHOOL OF MEDICINE
Institute
Department

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 東京慈恵会医科大学付属病院(東京都)

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 01 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 Preinitiation
Date of protocol fixation
2009 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 01 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
2009 Year 12 Month 18 Day
Last modified on
2009 Year 12 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003385

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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