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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000000636
Receipt No. 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

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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
Email

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
Email kitayama-1SU@h-u-tokyo.ac.jp

Sponsor
Institute Department of Surgical Oncology
The University of Tokyo
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000771

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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