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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000000746
Receipt No. R000000897
Scientific Title Phase II study of a combination of TS-1 and TXL for advanced/recurrent gastric cancer patients with peritoneal metastasis
Date of disclosure of the study information 2007/06/29
Last modified on 2009/12/04

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Basic information
Public title Phase II study of a combination of TS-1 and TXL for advanced/recurrent gastric cancer patients with peritoneal metastasis
Acronym OGSG0401
Scientific Title Phase II study of a combination of TS-1 and TXL for advanced/recurrent gastric cancer patients with peritoneal metastasis
Scientific Title:Acronym OGSG0401
Region
Japan

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

Objectives
Narrative objectives1 Effectiveness and adverse events are evaluated on the phase II study of a TS-1 plus Taxol therapy for advanced and/or recurrent gastric cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall Survival
Key secondary outcomes Response Rate
Time To No oral intake
Time To Progression
Adverse Events

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 TXL 50mg/m2 is administered on day 1 and day 8. And TS-1 80 mg/m2 is administered from day 1 to day 14 (14 days). One course is these 14days and subsequent no-treatment 7 days.
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 gastric cancer
2. advanced gastric cancer with peritoneal metastasis and/or ascites
1. unresectable due to peritoneal metastasis and/or ascites under X-ray
diagnosis
2. recurrent gastric cancer under diagnosis of biopsy, cytology or X-ray
3. with and without mesurable lesions
4. patient who can take orally ,
5. without any prior chemotherapy or radiation therapy
6. Age: 20-75 yo
7. written informed consent
8. expected survival period longer than 9 weeks
9. Performance status: 0-2 (ECOG criteria)
10. No obvious bone marrow function and sufficient renal/hepatic function a
Hemoglobin 8.0 g/dl <=
WBC: 4,000 /mm3 <= and =< 12,000/mm3
Neutrocyte: 2,000/mm3=<
Platelet: 100,000/mm3 =<
Total bilirubin: 1.5mg/dl =>
GOT, GPT: 100 IU/l =>
Creatinin: within normal range
CRP: 10mg/dl =>
Key exclusion criteria 1.with severe cavity fluid which needs drainage
2.with a central nerve symptoms
3.with fresh intestinal beeding
4.with active double cancers
5.with an allergic reaction against TS-1 or TXL
6.with severe allergy against medicine
7.with severe diseases (cardiac failure, arrhythmia, renal dysfunction, liver dysfunction, interstitial pneumonia, severe neural disorder, uncontrolled DM, intestinal obstruction, etc.)
8.under pregnancy or nursing
9.doctors' decision not to register
Target sample size 30

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 furukawa-h@sakai-hospital.jp

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 06 Month 29 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 Terminated
Date of protocol fixation
2003 Year 09 Month 16 Day
Date of IRB
Anticipated trial start date
2004 Year 03 Month 01 Day
Last follow-up date
2008 Year 03 Month 01 Day
Date of closure to data entry
2008 Year 10 Month 01 Day
Date trial data considered complete
2008 Year 10 Month 01 Day
Date analysis concluded
2008 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 06 Month 21 Day
Last modified on
2009 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000897

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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