UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of preoperative Docetaxel, cisplatin and S-1 in patients with clinically respectable type 4 , large type 3 and with extensive lymph node metastasis gastric cancer
Acronym	A Phase 2 study of preoperative Docetaxel, Cisplatin and S-1 therapy for locally advanced gastric cancer
Scientific Title	Phase II study of preoperative Docetaxel, cisplatin and S-1 in patients with clinically respectable type 4 , large type 3 and with extensive lymph node metastasis gastric cancer
Scientific Title:Acronym	A Phase 2 study of preoperative Docetaxel, Cisplatin and S-1 therapy for locally advanced gastric cancer
Region	Japan

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

Objectives
Narrative objectives1	To evaluate efficacy and feasibility of preoperative chemotherapy with Doceraxel, Cisplatin and S-1 for advanced gastric cancer (large type3, type4 or with extensive lymphnode metastasis)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

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	Preoperative chemotherapy with Docetaxel, cisplatin and S-1 followed by surgery.
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)histologically confirmed gastric adenocarcinoma. 2)Macroscopically large Type3 or Type4 gastric cancer or any Type of gastric cancer with massive Lymph-node metastasis 3)No evidence of peritoneal dissemination by diagnostic laparoscopy.(within 4week to entry) 4)Clinically Possible to curative resection. 5)Less than 3cm of esophageal invasion. 6)Age 20-80 years old 7)PS (ECOG) 0-1 8)No prior treatment 9)Sufficient oral intake 10)Adequate organ function 11)Written informed consent
Key exclusion criteria	1)Active malignancy in other organ 2)Serious complications 3)Acute inflammation 4)Allergy or hyper sensitivity to any drugs 5)Motor weakness or peripheral nerve disorder 6)With pleural or cardiac effusion 7)Pregnant or breast feeding 8)Interstitial pneumonia or pulmonary fibrosis 9)Psychological disease which require treatment 10)Hypersensitivity to S1 or CDDP or TXT 11)Systemic administration of other fluorouracil 12)Administration of flucytocine 13)Patients judged inappropriate for the study by the physicians
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Hitoshi Middle name Last name Murakami
Organization	Yokohama City University
Division name	Department of Surgery
Zip code	236-0004
Address	3-9, Fukuura, Kanazawa-ku, Yokohama
TEL	045-787-2645
Email	airgenzo@gmail.com

Public contact
Name of contact person	1st name Hitoshi Middle name Last name Murakami
Organization	Yokohama City University
Division name	Department of Surgery
Zip code	236-0004
Address	3-9, Fukuura, Kanazawa-ku, Yokohama
TEL	045-787-2645
Homepage URL
Email	m_air_h@yokohama-cu.ac.jp

Sponsor
Institute	Department of Surgery, Yokohama City University
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)

IRB Contact (For public release)
Organization	Yokohama City University
Address	3-9, Fukuura, Kanazawa-ku, Yokohama
Tel	045-787-2820
Email	rinri@fukuhp.yokohama-cu.ac.jp

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	横浜市立大学附属病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2010 Year 01 Month 18 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	Completed
Date of protocol fixation	2009 Year 07 Month 01 Day
Date of IRB	2009 Year 03 Month 13 Day
Anticipated trial start date	2009 Year 09 Month 01 Day
Last follow-up date	2016 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 06 Month 17 Day

Other
Other related information

Management information
Registered date	2010 Year 01 Month 17 Day
Last modified on	2021 Year 09 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003110