UMIN-CTR Clinical Trial

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

stage I-III stomach cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

JIKEI UNIVERSITY SCHOOL OF MEDICINE

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京慈恵会医科大学付属病院（東京都）

Date of disclosure of the study information

2010

Year

01

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2009

Year

12

Month

18

Day

Last modified on

2009

Year

12

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003385