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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002736
Receipt No. R000003329
Scientific Title A multi-centric Phase II study of intraperitoneal docetaxel combined with S-1 for patients with peritoneal dissemination of gastric cancer
Date of disclosure of the study information 2009/11/11
Last modified on 2011/11/10

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Basic information
Public title A multi-centric Phase II study of intraperitoneal docetaxel combined with S-1 for patients with peritoneal dissemination of gastric cancer
Acronym Phase II study of IP docetaxel with S-1 for peritoneal dissemination
Scientific Title A multi-centric Phase II study of intraperitoneal docetaxel combined with S-1 for patients with peritoneal dissemination of gastric cancer
Scientific Title:Acronym Phase II study of IP docetaxel with S-1 for peritoneal dissemination
Region
Japan

Condition
Condition primary gastric cancer with peritoneal dissemination
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of the study is to clarify the safety and efficacy of multimodality treatment
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes safety (completion rate)
Key secondary outcomes

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 Maneuver
Interventions/Control_1 2 courses of IP docetaxel combined with S-1 followed by laparoscopy
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. Adenocarcinoma of the stomach confirmed by endscopic biopsy
2. peritoneal dissemination confirmed by
cytology/biopsy using laparoscopy
3. no prior treatment
4. PS 0-2 (ECOG)
5. capable to oral intake
Key exclusion criteria 1. Severe medical condition
2. Malignant tumors of other organs
3. massive pleural effusion/ascites
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Fujimura
Organization Kanazawa University Hospital
Division name Department ofGastroenterological Surgery
Zip code
Address 13-1 Takara-machi, Kanazawa 920-8641, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kanazawa University Hospital
Division name Department ofGastroenterological Surgery
Zip code
Address
TEL
Homepage URL
Email fushida@staff.kanazawa-u.ac.jp

Sponsor
Institute Society for the Study of Peritoneal Dissemination in Gastric Cancer
Institute
Department

Funding Source
Organization None
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
2009 Year 11 Month 11 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2007 Year 11 Month 16 Day
Date of IRB
Anticipated trial start date
2007 Year 12 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 11 Month 10 Day
Last modified on
2011 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003329

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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