UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001119 |
|---|---|
| Receipt number | 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 15:36:39 |
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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
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
norisuke@kcch.jp
Sponsor or person
Institute
Department of Gastroenterology, Kitasato University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001358
