UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002736 |
|---|---|
| Receipt number | 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 09:42:51 |
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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
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
fushida@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Society for the Study of Peritoneal Dissemination in Gastric Cancer
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003329
| 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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