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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001119
Receipt No. R000001358
Scientific Title Phase II study of the combination of docetaxel, cisplatin plus S-1(DCS) for advanced or recurrent gastric cancer(KDOG 0601)
Date of disclosure of the study information 2008/04/14
Last modified on 2012/04/13

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Basic information
Public title Phase II study of the combination of docetaxel, cisplatin plus S-1(DCS) for advanced or recurrent gastric cancer(KDOG 0601)
Acronym Phase II study of DCS for advanced gastric cancer
Scientific Title Phase II study of the combination of docetaxel, cisplatin plus S-1(DCS) for advanced or recurrent gastric cancer(KDOG 0601)
Scientific Title:Acronym Phase II study of DCS for advanced gastric cancer
Region
Japan

Condition
Condition Gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine the efficacy and safety of combination chemothrapy with Docetaxel, cisplatin and S-1 in advanced or recurrent gastric cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes efficacy
Key secondary outcomes Adverse events,PFS,MST,TTP

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 S-1 80 mg/m2 PO BID days 1-14
Docetaxel 40 mg/m2 DIV day 1
Cisplatin 60 mg/m2 DIV day 1
every 28 days
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) Measurable disease by Response Evaluation Criteria in Solid Tumors Group (RECIST)
3) No prior chemotherapy or radiation therapy for gastric cancer
4) Age between 20 and 80 years
5) Adequate organ function
1. WBC >=3,000/mm3,
2. platelets >=100,000/mm3
3. T-Bil <=1.5 mg/dL
4. GOT, GPT <=100 U/L
5. Cr <=1.5 mg/dL
6. creatinine clearance >50ml/min
7. normal ECG
6) ECOG performance status (PS) of 0 to 2
7) Oral food intake possible
8) A life expectancy of at least 8 weeks
9) Written informed
Key exclusion criteria 1)Patients contraindicated to docetaxel,cisplatin,S-1
2)Active infection
3)Severe heart disease
4)Uncontrolled medical conditions (paralytic ileus,bowel obstruciton,interstitial pneumonia,pulmonary fibrosis,uncontrollable diabetes mellitus,renal failure,liver cirrhosis)
5)Massive abdominal effusion or massive pleural effusion
6)Extensive bone metastasis
7)Symptomatic brain metastasis
8)Severe diarrhea
9)Severe mental disorder
10)Histroy of other active malignancy
11)Pregnancy, the desire to preserve
12)Inadequate physical condition, as diagnosed by primary physician
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Wasaburo Koizumi
Organization Kitasato University East Hospital
Division name Department of Gastroenterology
Zip code
Address 2-2-1, Asamizodai, Sagamihara
TEL 042-748-9111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Norisuke Nakayama
Organization Kanagawa Cancer Center
Division name Division of Gastroenterology
Zip code
Address 1-1-2, Nakao, Asahi-ku, Yokohama
TEL 045-391-5761
Homepage URL
Email norisuke@kcch.jp

Sponsor
Institute Department of Gastroenterology, Kitasato University School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Kanagawa Cancer Center
Kitasato university Hospital
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
2008 Year 04 Month 14 Day

Related information
URL releasing protocol
Publication of results 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 Completed
Date of protocol fixation
2006 Year 02 Month 09 Day
Date of IRB
Anticipated trial start date
2006 Year 10 Month 01 Day
Last follow-up date
2009 Year 10 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
2008 Year 04 Month 13 Day
Last modified on
2012 Year 04 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001358

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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