UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000746 |
|---|---|
| Receipt number | 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 17:42:41 |
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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
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
furukawa-h@sakai-hospital.jp
Sponsor or person
Institute
OGSG
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000897
