UMIN-CTR Clinical Trial

Public title

A pharmaco-kinetic study on TS-1+CDDP+PTXtreatment for advanced and/or metastatic gastric cancer (OGSG 0703 plus)

Acronym

OGSG 0703

Scientific Title

A pharmaco-kinetic study on TS-1+CDDP+PTXtreatment for advanced and/or metastatic gastric cancer (OGSG 0703 plus)

Scientific Title:Acronym

OGSG 0703

Region

Japan

Condition

advanced and/or metastatic gastric cancer

Classification by specialty

Hematology and clinical oncology	Surgery in general	Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

To compare the PK profile on day 14 of TS-1 treatment to that on day 15 of TS-1+CDDP+PTX treatment to confirm the feasibility and propriety of dose setting

Basic objectives2

Pharmacokinetics

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Serum concentration of TS-1, CDDP and PTX and the kinetics of them

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Administration of medicines
One course takes 5 weeks (35 days):
TS-1 (80 mg/m2) is administrated orally 3 weeks followed by 2 weeks rest.
CDDP(30mg/m2) and PTX(70mg/m2) are administered intravenously on day 1 and day 15.
Blood samples and detections:
Blood samples are taken 7 times (before, 1 hrs, 3hrs, 4hrs, 6hrs, 10hrs, and 24 hrs) on day 14 and day 15.
Serum concentration of TS-1, CDDP and PTX are detected from samples.

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

Age-lower limit

20

years-old

<=

Age-upper limit

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. Histologically proven colon cancer or rectal cancer
2. with measurable lesions for RECIST criteria
3. without prior therapy (Radiation therapy, chemotherapy, hormone
therapy). Eligible if patient was completed prior therapy 4 weeks before
start of this therapy
4. Functions of important organs are within normal range:
<1> Hb : >= 8.0 g/dL
<2> WBC : 4000-12000 /mm3
<3> Neutro. : >=2000mm3
<4> Platelet : >=10x104/mm3
<5> totl bil. : <=1.5mg/dL
<6> AST,ALT : <100 IU/L
Eligible <= 150 IU/L due to liver metastasis
<7> sCr : <=1.2 mg/dL
<8> CCr : >=60mL/min calculated by Cockcraft-Gault mathod
5. Performance Status (ECOG): 0-2
6. expected survival; >= 3 months
7. age: 20-75 years old
8. with ability of oral intake
9. Written informed consent to participate in this study

Key exclusion criteria

1. with fresh bleeding from digestive tract
2. without ability of oral intake due to digestive tract obstruction
3. with history of severe allergy against medicine, especially,
Medicines including Polyethylene-caster oil
4. with ascites and/or pleural fluid
5. with severe diseases (infectious diseases, interstitial pneumonia,
Pulmonary fibrosis, cardiac dysfunction, renal dysfunction, liver
dysfunction, uncontrolled DM etc)
6. with liver cirrhosis and/or jaundice
7. under treatment using psychotrophic agents or with a disease which
needs psychological treatment
8. with some symptoms due to brain metastasis
9. with active double cancer
10. pregnant or nursing lady or lady with expectation of pregnancy
11. Any other patient whom the physician in charge of the study judges to be not eligible

Target sample size

6

Name of lead principal investigator

1st name
Middle name
Last name	Kimura Yutaka

Organization

NTT West Osaka Hospital

Division name

Dpt.Digestive Diseases

Zip code

Address

2-6-40Karasugatuji Tennnouji-Ku Osaka543-8922

TEL

06-6773-7111

Email

Name of contact person

1st name
Middle name
Last name	Furukawa Hiroshi

Organization

Sakai City Hospital

Division name

Director

Zip code

Address

1-1-1,Minamiyasuicho,Sakai-ku,Sakai, 590-0064

TEL

072-221-1700

Homepage URL

Email

Institute

OGSG

Institute

Department

Personal name

Organization

NPO Osaka Chinical Study Supporting Organization

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

Date of disclosure of the study information

2009

Year

12

Month

28

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

Completed

Date of protocol fixation

2009

Year

12

Month

28

Day

Date of IRB

Anticipated trial start date

2009

Year

12

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

28

Day

Last modified on

2021

Year

11

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003590