UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002183 |
|---|---|
| Receipt number | R000002679 |
| Scientific Title | A Phase I/II study of combination of TS-1, CDDP plus PTX in patients with advanced/recurrent gastric cancer (OGSG 0703) |
| Date of disclosure of the study information | 2009/07/10 |
| Last modified on | 2013/01/10 20:35:56 |
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Basic information
Public title
A Phase I/II study of combination of TS-1, CDDP plus PTX in patients with advanced/recurrent gastric cancer (OGSG 0703)
Acronym
A Phase I/II study of combination of TS-1, CDDP plus PTX in patients with advanced/recurrent gastric cancer (OGSG 0703)
Scientific Title
A Phase I/II study of combination of TS-1, CDDP plus PTX in patients with advanced/recurrent gastric cancer (OGSG 0703)
Scientific Title:Acronym
A Phase I/II study of combination of TS-1, CDDP plus PTX in patients with advanced/recurrent gastric cancer (OGSG 0703)
Region
| Japan |
Condition
Condition
advanced/recurrent gastric cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A regimen of TS-1+CDDP plus PTX for outpatients with advanced /recurrent
gastric cancer is to be studied on the effectiveness and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
overall survival(OS),progression free survival, and Incidence of 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
Treatment Methd
CDDP 30mg/m2:day 1, day15,
PTX 70mg/m2:day 1, day15,
TS-1 80/mgm2:day1 – 21(on), day22 – 35(off)
A 5 weeks is the one course
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) diagnosed histologicaly and/or cytologicaly
(2) with measurable lesions
(3) without any prior therapy except patients who have received other Chemotherapies than CDDP, PTX or TS-1 before 4 weeks of this Study
(4) with normal organ functions
1) Hb <= 8.0g/dL
2) WBC:4,000-12000/mm3
3) Neutro: <=2000/mm3
4) Platelet: <=10x104/mm3
5) T.bil: >=1.5mg/dL
6) AST/ALT: <100 IU/L or <150 IU/L in patients with liver
Metastasis
7) sCr <= 1.2mg/dL1.
8) CCr >= 60mL/min in Cockcroft-Gault method
(5) PS 0-2
(6) longer than 3 months of the expected survival period
(7) age between 20 and 75 years old
(8) patients who can take orally
(9) with written informed consent
Key exclusion criteria
(1) with bleeding from digestive tract
(2) patients who cannot take orally due to some stenosis on digestive tract
(3) past history of severe allergy against some medicines
(4) with high volume of ascites and/or thoratic fluid
(5) with severe diseases (infection, interstitial pneumonitis, pulmonary fibrosis, cardiac failure, renal failure, liver disease, uncontrollable DM)
(6) with liver cirrhosis and/or jaundice
(7) with psychologic disorder which needs medicines
(8) with brain disorder due to brain metastasis
(9) with active second cancers.
(10) women under pregnancy or women expecting future birth
(11) doctors decision not to register to this trial
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimura Yutaka |
Organization
NTT West Japan Hospital
Division name
Dpt.Surgery
Zip code
Address
543-8922 2-6-40Karasugatuji Tennnouji-Ku Osaka
TEL
06-6773-7111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Furukawa |
Organization
Kinki University Faculty of Medicen
Division name
Department of surgery
Zip code
Address
377-2, Onohigashi, Osakasayama, Osaka, Japan
TEL
072-366-0221
Homepage URL
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
| 2009 | Year | 07 | Month | 10 | 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
| 2009 | Year | 05 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 05 | Month | 21 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
| 2012 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 07 | Month | 10 | Day |
Last modified on
| 2013 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002679
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