UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000484 |
|---|---|
| Receipt number | 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 23:23:15 |
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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
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
ayhosoka@med.u-toyama.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hematology, Faculty of Medicine, University of Toyama
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000581
