UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000636 |
|---|---|
| Receipt number | R000000771 |
| Scientific Title | The efficacy and feasibility of the repeated intraperitoneal Paclitaxel +systemic TS-1 and Paclitaxel for far advanced or recurrent gastric cancer: Phase I/II trial. |
| Date of disclosure of the study information | 2008/08/30 |
| Last modified on | 2008/11/18 20:12:42 |
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Basic information
Public title
The efficacy and feasibility of the repeated intraperitoneal Paclitaxel +systemic TS-1 and Paclitaxel for far advanced or recurrent gastric cancer: Phase I/II trial.
Acronym
The clinical effects of additional repeated intraperitoneal Paclitaxel for advanced gastric cancer.
Scientific Title
The efficacy and feasibility of the repeated intraperitoneal Paclitaxel +systemic TS-1 and Paclitaxel for far advanced or recurrent gastric cancer: Phase I/II trial.
Scientific Title:Acronym
The clinical effects of additional repeated intraperitoneal Paclitaxel for advanced gastric cancer.
Region
| Japan |
Condition
Condition
Far advanced or recurrent gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the efficacy and safety of the repeated intraperitoneal Paclitaxel for non-resectable gastric cancer, especially that with peritoneal dissemination.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
side effects
1-year survival
Key secondary outcomes
plasma level of taxol
response rate
Duration of overall Response
Duration of complete Response
Duration of Stable DiseaseTime To Progression
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1.Oral TS-1 80mg/m2 every day
2.Intravenous Paclitaxel 50mg/m2 every week
3.intraperitoneal Paclitaxel every week
2 week administration and 1 week off
x3 cycles
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Non-resectable gastric cancer with peritoneal dissemination, or positive peritoneal cytology.
Key exclusion criteria
Other hematogeneous metastasis
multiple cancers
other cases who are decided to be inappropriate for the clinical trial by doctors.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Joji Kitayama |
Organization
The University of Tokyo
Division name
Department of Surgical Oncology
Zip code
Address
Hongo 7-3-1, Bunkyo-ku, Tokyo
TEL
03-3815-5411.33246
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Joji Kitayama |
Organization
The University of Tokyo
Division name
Department of Surgical Oncology
Zip code
Address
Hongo 7-3-1, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
http://all-1su.umin.jp/ip_pacli.html
kitayama-1SU@h-u-tokyo.ac.jp
Sponsor or person
Institute
Department of Surgical Oncology
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research Japan society of the promotion of science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2008 | Year | 08 | Month | 30 | 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
Date of protocol fixation
| 2006 | Year | 07 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 03 | Month | 12 | Day |
Last modified on
| 2008 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000771
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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