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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000484
Receipt No. R000000581
Scientific Title Phase I/II Study of S-1, Cisplatin and Docetaxel in Patients with Advanced Gastric Cancer
Date of disclosure of the study information 2006/09/11
Last modified on 2016/06/26

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Basic information
Public title Phase I/II Study of S-1, Cisplatin and Docetaxel in Patients with Advanced Gastric Cancer
Acronym Phase I/II Study of S-1, Cisplatin and Docetaxel in Patients with Advanced Gastric Cancer
Scientific Title Phase I/II Study of S-1, Cisplatin and Docetaxel in Patients with Advanced Gastric Cancer
Scientific Title:Acronym Phase I/II Study of S-1, Cisplatin and Docetaxel in Patients with Advanced Gastric Cancer
Region
Japan

Condition
Condition untreated advanced or recurrent gastric cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of S-1, cisplatin and docetaxelin patients with advanced gastric cancer, and to evaluate efficacy and safety of this combination therapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Phase I: Maximum Tolerated Dose, Recommended dose
Phase II: Response rate
Key secondary outcomes Toxicity, Progression free survival, Overall survival

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 Cisplatin, Day1
Level 0: 30mg/m2
Level 1: 40mg/m2
Level 2: 50mg/m2
Level 3: 60mg/m2
S-1 (80mg/m2), Day1-14, 22-35
Docetaxel (40mg/m2), Day22
Repeat every 6 weeks
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) Histologically or cytologically confirmed adenocarcinoma of the stomach
2) Unresectable disease
3) Sufficient oral intake
4) Measurable lesion(s) defined by RECIST
5) No prior chemotherapy, radiotherapy for advanced cancer
6) Age of 20-74 years
7) ECOG performance status of 0 to 2
8) Expected survival more than 3 months
9) Adequate organ function
10) Written informed consent

Key exclusion criteria 1) Active other malignancy
2) Interstitial pneumonitis, pulmonary fibrosis
3) Massive pleural effusion or massive ascites
4) Active infection
5) Watery diarrhea
6) Other uncontrolled severe illness
7) Brain metastases
8) Pregnant or lactating women
9) Not appropriate for the study at the physician's assessment
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiro Sugiyama
Organization University of Toyama
Division name Department of Gastroenterology and Hematology, Faculty of Medicine
Zip code
Address 2630 Sugitani, Toyama, 930-0194, Japan
TEL 076-434-7301
Email tsugi@med.u-toyama.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ayumu Hosokawa
Organization University of Toyama
Division name Department of Gastroenterology and Hematology, Faculty of Medicine
Zip code
Address 2630 Sugitani, Toyama, 930-0194, Japan
TEL 076-434-7301
Homepage URL
Email ayhosoka@med.u-toyama.ac.jp

Sponsor
Institute Department of Gastroenterology and Hematology, Faculty of Medicine, University of Toyama
Institute
Department

Funding Source
Organization Department of Gastroenterology and Hematology, Faculty of Medicine, University of Toyama
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
2006 Year 09 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
2006 Year 07 Month 25 Day
Date of IRB
Anticipated trial start date
2006 Year 08 Month 01 Day
Last follow-up date
2011 Year 08 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
2006 Year 09 Month 11 Day
Last modified on
2016 Year 06 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000581

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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