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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002951
Receipt No. R000003590
Scientific Title A pharmaco-kinetic study on TS-1+CDDP+PTXtreatment for advanced and/or metastatic gastric cancer
Date of disclosure of the study information 2009/12/28
Last modified on 2011/02/09

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Basic information
Public title A pharmaco-kinetic study on TS-1+CDDP+PTXtreatment for advanced and/or metastatic gastric cancer
Acronym OGSG 0703
Scientific Title A pharmaco-kinetic study on TS-1+CDDP+PTXtreatment for advanced and/or metastatic gastric cancer
Scientific Title:Acronym OGSG 0703
Region
Japan

Condition
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

Objectives
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

Assessment
Primary outcomes Serum concentration of TS-1, CDDP and PTX and the kinetics of them
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute OGSG
Institute
Department

Funding Source
Organization NPO Osaka Chinical Study Supporting Organization
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

Other administrative information
Date of disclosure of the study information
2009 Year 12 Month 28 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 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
Other related information

Management information
Registered date
2009 Year 12 Month 28 Day
Last modified on
2011 Year 02 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003590

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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