UMIN-CTR Clinical Trial

Basic information
Public title	Phase I study of TS-1+CDDP+PTX therapy in patients with advanced/recurrent gastric cancer (OGSG 0703)
Acronym	OGSG 0703
Scientific Title	Phase I study of TS-1+CDDP+PTX therapy in patients with advanced/recurrent gastric cancer (OGSG 0703)
Scientific Title:Acronym	OGSG 0703
Region	Japan

Condition
Condition	Patients with unresectable or metastatic gastric cancer
Classification by specialty	Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	A new treatment methd will be developed using TS-1, CDDP and PTX for unresectable or metastatic gastric cancer. The recommendable use and dose should be decided through adverse events.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	Adverse Events, maximum tolerated dose, recommended dose
Key secondary outcomes	Response Rate(RECIST)

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	................Day1........day15.......day21.......day35 CDDP....*...............* PTX........*...............* TS-1......80, 100, 120mg/day.......interval .................Day1 - day21............day22-day35 .....................One course takes 5 weeks.
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) gastric cancer proven histologically 2) with measurable lesion or detectable lesion 3) without prior chemotherapy (radiation therapy, chemotherapy or hormone therapy) Patients with the last prior therapy before more than 4 weeks of registration can be registered. 4) sufficient function of important organs from the deta before 2 weeks of registration O hemoglobin: >= 8.0 mg/dl O WBC: >= 4,000 and =< 12,000/mm3 O Platelet: >= 100,000/mm3 O sGOT,sGPT: < 100 IU/L O sT.bil.: <= 1.5 mg/dl O sCreatinin: <= upper limit of each institute *Creatinin clearance: >= 60 ml/min (Cockcroft-Gault method) 5) age: =>20 and 75=> 6) Performance Status: 0-1 (ECOG criteria) 7) more than 3 months of expected survival period 8) patients who can take food orally 9) written informed consent
Key exclusion criteria	1) with fresh intestinal bleeding 2) patient who cannot be administered anticancer agents due to intestinal obstraction 3) history of severe allergy against drug 4) with severe thoracic fluid and/or ascites 5) with severe diseases (infection, interstitial pneumonitis, pulmonary fibrosis, cardiac failure, liver dysfunction, renal dysfunction or uncontrolled DM) which disturb registration to this study 6) with liver scirrhosis and/ or jaundice 7) patients with mental disprder who need medicines and/or treatments 8) with brain metastasis and its symptoms 9) with active double cancer 10) pregnant women or women who like to be pregnant 11) doctor's dicision not to be registered to this study
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	2007 Year 11 Month 24 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	2007 Year 11 Month 02 Day
Date of IRB
Anticipated trial start date	2007 Year 12 Month 01 Day
Last follow-up date	2009 Year 05 Month 01 Day
Date of closure to data entry	2009 Year 05 Month 01 Day
Date trial data considered complete	2009 Year 05 Month 01 Day
Date analysis concluded	2009 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date	2007 Year 11 Month 22 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=R000001089