UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of preoperative TS-1+CDDP therapy for advanced gastric cancer (OGSG 0004)
Acronym	OGSG 0004
Scientific Title	Phase II study of preoperative TS-1+CDDP therapy for advanced gastric cancer (OGSG 0004)
Scientific Title:Acronym	OGSG 0004
Region	Japan

Condition
Condition	Patients with unresectable gastric cancer due to limited inavasion or metastasis.
Classification by specialty	Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	TS-1 plus CDDP treatment is evaluated in terms of response rate and adverse events for patients with advanced gastric cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Response Rate(RECIST), probability on completion
Key secondary outcomes	Overall Survival, Resectability, Recurrence Mode

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...day8.......day21...day35....day42.......day56 (--TS-1---------).......(---TS-1--------) CDDP60mg/m2..................CDDP60mg/m2 .....................................2ws rest
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) Patients with unresectable advanced gastric cancer due to limited inavasion or metastasis 2) cP0, CY0, cH0, cM0, and cT4, cN1, or cT2-4, cN2, cM1 (LYM) *cM1(LYM): distant lymph nodes in the abdomen which can be removed 3) biopsy by endoscopy showed gastric cancer, histologically 4) without prior chemotherapy 5) with measurable metastatic lymph nodes in RECIST criteria Measurable lesions: lesions larger than 10mm in spiral CT, or 20mm in common CT 6) without liver metastasis and/or peritoneal metastasis by abdominal echo, CT or laparoscopy. 7) without distant metastasis by blood examination, or chest X-ray, Without mediastinal lymph node metastasis by chast X-ray 8) age: =>20 and 75=> 9) Performance Status: 0-1 (ECOG criteria) 10) sufficient function of important organs O WBC: >= 4,000 and =< 12,000/mm3 O Hb >=8.0g/dl O Platelet: >= 100,000/mm3 O sGOT,sGPT: <100 IU/l O sT.bil.: <= 1.5 mg/dl O sCreatinin: <= 1.2mg/dl O respiratory function: PaO2 in room air >=70 torr 11) written informed consent
Key exclusion criteria	1) Under fresh bleeding from digestive tract 2) Patient who cannot take anticancer medicine orally due to gastrointestinal stenosis. 3) Type 4 gastric cancer 4) history of severe allergy against drug 5) under watery diarrhea 6) with sever disease on important organs (Infection, interstitial pneumonitis, pulmonary fibrosis, cardiac disease, renal dysfunction, liver dysfunction, DM controlled by insulin) 7) double cancer without carcinoma in citu 8) pregnant women or women who like to be pregnant 9) doctor' s dicision not to be registered to this study
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasushi Nakane
Organization	Kansai Medical University
Division name	Dpt. surgery
Zip code
Address	10-15 Fumizono-cho Moriguchi-shi 570-8506
TEL	06-6992-1001
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 12 Month 08 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	2002 Year 08 Month 08 Day
Date of IRB
Anticipated trial start date	2002 Year 08 Month 01 Day
Last follow-up date	2008 Year 09 Month 01 Day
Date of closure to data entry	2008 Year 09 Month 01 Day
Date trial data considered complete	2008 Year 09 Month 01 Day
Date analysis concluded	2008 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date	2007 Year 12 Month 06 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=R000001121