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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002524
Receipt No. R000003083
Scientific Title A Phase I study of induction chemotherapy with S-1 and Cisplatin plus intraperitoneal administration of Docetaxel for gastric cancer with peritoneal dissemination
Date of disclosure of the study information 2010/01/01
Last modified on 2010/09/24

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Basic information
Public title A Phase I study of induction chemotherapy with S-1 and Cisplatin plus intraperitoneal administration of Docetaxel for gastric cancer with peritoneal dissemination
Acronym A Phase I study of intraperitoneal Docetaxcel with S-1 and Cisplatin for gastric cancer with peritoneal dissemination (KUGC05)
Scientific Title A Phase I study of induction chemotherapy with S-1 and Cisplatin plus intraperitoneal administration of Docetaxel for gastric cancer with peritoneal dissemination
Scientific Title:Acronym A Phase I study of intraperitoneal Docetaxcel with S-1 and Cisplatin for gastric cancer with peritoneal dissemination (KUGC05)
Region
Japan

Condition
Condition gastric cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the safety and to determine the recommended dose of intraperitoneal docetaxel plus systemic S-1 and cisplatin for gastric cancer with peritoneal dissemination
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To determine the maximum tolerated dose and the recommended dose
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Chemotherapy
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Histological diagnosis of gastric adenocarcinoma
2) Laparoscopy revealed macro- or microscopic peritoneal dissemination as the only factor for Stage IV
3) Distant metastasis was excluded by image diagnosis
4) No prior therapy for gastric cancer
5) Performance Status (ECOG):0-1
6) Oral intake of S-1 is possible
7) Written informed consent
8) Biology and biochemistry within normal limits
Key exclusion criteria 1)Active bleeding from the tumor
2)Paralysis of intestine or ileus
3)Diarrhea(watery stool)
4)Synchronous multicancer
5)Pleural effusion or ascites requiring control
6)Serious comorbidity including
-Serious infection
-Uncontrollable diabetes mellitus
-Heart failure requireing control
-Uncontrolled arrhythmia or angina
-Severe phyciatric disease
-Interstitial pneumonitis or fibroid lung
7)Myocardial infarction within 6 months
8)Patient who has experienced serious allergy for any drug or polysorbate 80 in the past
9)Patient who is pregnant or in lactation, or wish to become pregnant during this study.Male patient who intends to make someone pregnant during this study
10)Patient who requires continuous use of flucytosine
11)Patient who is judged to be inappropriate as subject to this study by the principal investigator or the doctors in charge
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiharu Sakai
Organization Graduate School of Medicine, Kyoto University
Division name Department of Surgery
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Okabe
Organization Graduate School of Medicine, Kyoto University
Division name Department of Surgery
Zip code
Address
TEL
Homepage URL
Email hokabe@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Surgery
Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization Department of Surgery
Graduate School of Medicine, Kyoto University
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
2010 Year 01 Month 01 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 Terminated
Date of protocol fixation
2009 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 Day
Last follow-up date
2012 Year 07 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 09 Month 18 Day
Last modified on
2010 Year 09 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003083

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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