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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000934
Receipt No. R000001121
Scientific Title Phase II study of preoperative TS-1+CDDP therapy for advanced gastric cancer.
Date of disclosure of the study information 2007/12/08
Last modified on 2008/09/11

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Basic information
Public title Phase II study of preoperative TS-1+CDDP therapy for advanced gastric cancer.
Acronym OGSG 0004
Scientific Title Phase II study of preoperative TS-1+CDDP therapy for advanced gastric cancer.
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
2008 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001121

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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