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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000002081
Receipt No. R000002537
Scientific Title preoperative combined chemothrapy with docetaxel, cisplatin and S-1 in local advanced gastric cancer; multicentric phase II study
Date of disclosure of the study information 2009/07/01
Last modified on 2018/06/23

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Basic information
Public title preoperative combined chemothrapy with docetaxel, cisplatin and S-1 in local advanced gastric cancer; multicentric phase II study
Acronym preoperative DCS therapy in local advanced gastric cancer
Scientific Title preoperative combined chemothrapy with docetaxel, cisplatin and S-1 in local advanced gastric cancer; multicentric phase II study
Scientific Title:Acronym 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
1st name
Middle name
Last name Atsushi Nashimoto
Organization Society for the study of DCS therapy
Division name Surgery, Niigata Cancer Center Hospital
Zip code
Address 2-15-3 Kawagishi-chou, Niigata
TEL 025-266-5112
Email nasimoto@niigata-cc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sachio Fushida
Organization Kanazawa University Hospital
Division name Gastroenterological Surgery
Zip code
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)

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
2009 Year 07 Month 01 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 Main results already published
Date of protocol fixation
2009 Year 07 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000002537

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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