UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003642 |
|---|---|
| Receipt number | R000004268 |
| Scientific Title | A phase II trial of neoadjuvant chemotherapy with docetaxel,cisplatin and S-1 (DCS) for radically resectable advanced gastric carcinoma (KDOG 1001) |
| Date of disclosure of the study information | 2010/05/19 |
| Last modified on | 2015/04/29 21:12:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A phase II trial of neoadjuvant chemotherapy with docetaxel,cisplatin and S-1 (DCS) for radically resectable advanced gastric carcinoma (KDOG 1001)
Acronym
A phase II trial of neoadjuvant chemotherapy with DCS for radically resectable advanced gastric carcinoma (KDOG 1001)
Scientific Title
A phase II trial of neoadjuvant chemotherapy with docetaxel,cisplatin and S-1 (DCS) for radically resectable advanced gastric carcinoma (KDOG 1001)
Scientific Title:Acronym
A phase II trial of neoadjuvant chemotherapy with DCS for radically resectable advanced gastric carcinoma (KDOG 1001)
Region
| Japan |
Condition
Condition
radically resectable advanced gastric carcinoma
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To estimate efficacy and safety of neoadjuvant chemotherapy with docetaxel, cisplatin and S-1 for radically resectable advanced gastric carcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
rate of radical resection
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
neoadjuvant chemoterapy with docetaxel, cisplatin and S-1
gastrectomy
adjuvant chemoterapy with S-1
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 carcinoma.
2. radically resectable large type 3, type 4 tumor, or bulky N2 lymphnode metastases
3. cM0, no peritoneal dissemination were proved by laparoscopy
4. Performance Status:0-2(ECOG)
5. Sufficient organ functions
6. Written informed consent
Key exclusion criteria
1. Active synchronous malignancy
2. History of serious drug hypersensitivity
3. Severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema or etc)
4. Severe heart disease (congestive heart failure, symptomatic ischemic heart disease, uncontrolled arrhythmia, or etc)
5. Severe mental disorders, neurological disease
6. Pregnant or lactation women, or women with the possibility of the pregnancy and men who want let to pregnancy
7. Patients who are judged inappropriate for the entry into this study by the investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Wasaburo Koizumi |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
1-15-1, Kitazato, Sagamihara, Kanagawa, Japan
TEL
042-778-8111
koizumi@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mizutomo Azuma |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
1-15-1, Kitazato, Sagamihara, Kanagawa, Japan
TEL
042-778-8111
Homepage URL
mizutomo@med.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kitasato University School of Medicine, Department of Gastroenterology
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
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
| 2010 | Year | 05 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 05 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 19 | Day |
Last modified on
| 2015 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004268
