UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I/II Study of S-1, Cisplatin and Docetaxel in Patients with Advanced Gastric Cancer
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Toshiro Sugiyama
Organization	University of Toyama
Division name	Department of Gastroenterology and Hematology, Faculty of Medicine
Address	2630 Sugitani, Toyama, 930-0194, Japan
TEL	076-434-7301
Email	tsugi@med.u-toyama.ac.jp

Public contact
Name of contact person	Ayumu Hosokawa
Organization	University of Toyama
Division name	Department of Gastroenterology and Hematology, Faculty of Medicine
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2006 Year 07 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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