UMIN-CTR Clinical Trial

Basic information
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
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	2021 Year 11 Month 15 Day

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