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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000000875
Receipt No. R000001046
Scientific Title Phase II study of docetaxel and S-1 as neoadjuvant chemotherapy + gastrectomy for cStage IIIa-IIIb(IV) resectable gastric cancer
Date of disclosure of the study information 2007/11/05
Last modified on 2009/10/28

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Basic information
Public title Phase II study of docetaxel and S-1 as neoadjuvant chemotherapy + gastrectomy for cStage IIIa-IIIb(IV) resectable gastric cancer
Acronym Docetaxel and S-1 as neoadjuvant chemothrapy for resectable gastric cancer
Scientific Title Phase II study of docetaxel and S-1 as neoadjuvant chemotherapy + gastrectomy for cStage IIIa-IIIb(IV) resectable gastric cancer
Scientific Title:Acronym Docetaxel and S-1 as neoadjuvant chemothrapy for resectable gastric cancer
Region
Japan

Condition
Condition clinical stage IIIa-IIIb(IV) gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety and efficacy of docetaxel and S-1 as neoadjuvant chemotherapy for patients with stage IIIa, IIIb or IV (cT4N2) gastric cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Pathological response
Key secondary outcomes Response rate of neoadjuvant chemotherapy
Treatment completion rate
Complete resection rate
3 year relapse free survival
3 year overall survival
Adverse events

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 Docetaxel 35 mg/m2 1-hour IV days 1,15
S-1 80 mg/m2 PO BID days 1-14,
every 28 days for 2 cycles followed by
gastrectomy with D2 lymph node dissection
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 Histologically or cytologically confirmed adenocarcinoma of the stomach,
curative resection possible,
CY0, P0, H0 by laparoscopy,
Age 20-80 years old,
No prior therapy including surgery, radiotherapy or chemotherapy for current disease,
patients who can take medication orally,
ECOG performance status 0-1,
Adequate cardiac, hepatic, renal, respiratory, and bone marrow functions, Written informed consent.
Key exclusion criteria A history of other malignancies within the last 5 years except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix,
patients contraindicated to S-1,
A history of severe drug hypersensitivity,
Uncontrolled medical conditions , Documented or suspected infection, Patients requiring treatment with corticosteroids except for pre-medication,
Hepatitis B or C,
patients with diarrhea,
Pregnant or lactating women and women of child bearing potential not using contraception,
Severe psychiatric disorders,
Severe edema,
Grade 2 or grater peripheral neuropathy,
HIV positive,
patients judged by the investigator as unfit to be enrolled in the study.
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiko Maehara
Organization Kyushu University
Graduate School of Medical Sciences
Division name Dept. of Surgery and Science
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan 812-8582
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiro Kakeji
Organization Kyushu University
Division name Dept. of Surgery and Science
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan 812-8582
TEL
Homepage URL
Email

Sponsor
Institute Dept. of Surgery and Science, Kyushu 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
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
2007 Year 11 Month 05 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 No longer recruiting
Date of protocol fixation
2007 Year 06 Month 21 Day
Date of IRB
Anticipated trial start date
2007 Year 11 Month 01 Day
Last follow-up date
2012 Year 11 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
2007 Year 11 Month 02 Day
Last modified on
2009 Year 10 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001046

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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