UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	preoperative combined chemothrapy with docetaxel, cisplatin and S-1 in local advanced gastric cancer; multicentric phase II study
Title of the study (Brief title)	preoperative DCS therapy in local advanced gastric cancer
Region	Japan

Condition
Condition	local advanced gastric cancer (excluding T3-4, bulky N2 & N3 and giant type3 & type 4)
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of preoperative combined chemotherapy with docetaxel, cisplatin and S-1 in local advanced gastric cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	pathological response
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 DCS therapy followed by gastrectomy. docetaxel 35mg/m2/ D1, 8/ q4w cisplatin 35mg/m2/ D1, 8/ q4w S-1 80mg/m2/ D1-14/ q4w
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 confirmed gastric adenocarcinoma 2) local advanced gastric cancer (T3-4, absence of peritoneal metastases confirmed by laparoscopy) 3) esophageal invasion < 3cm 4) age of 20-75 5) PS 0-1 (ECOG) 6) no prior treatment 7) no obvious bleeding from primary tumor 8) enable to ingestion 9) adequate organ function 10) written informed consent
Key exclusion criteria	1) obvious infection 2) severe complication 3) active other malignancies 4) distant metastases 5) motor palalysis or peripheral neuropathy 6) drug hypersensitivity 7) mental disorder 8) possibility of pregnancy 9) judged as unsuitable by the doctor in charge
Target sample size	55

Research contact person
Name of lead principal investigator	Atsushi Nashimoto
Organization	Society for the study of DCS therapy
Division name	Surgery, Niigata Cancer Center Hospital
Address	2-15-3 Kawagishi-chou, Niigata
TEL	025-266-5112
Email	nasimoto@niigata-cc.jp

Public contact
Name of contact person	Sachio Fushida
Organization	Kanazawa University Hospital
Division name	Gastroenterological Surgery
Address	13-1 Takara-machi, Kanazawa
TEL	076-265-2362
Homepage URL
Email	fushida@staff.kanazawa-u.ac.jp

Sponsor
Institute	Society for the study of DCS therapy
Institute
Department

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)

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 07 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2009 Year 07 Month 01 Day
Anticipated trial start date	2009 Year 07 Month 01 Day
Last follow-up date	2015 Year 06 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	2009 Year 06 Month 16 Day
Last modified on	2018 Year 06 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000002537