UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002081 |
|---|---|
| Receipt number | 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 13:49:00 |
* 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
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
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
fushida@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Society for the study of DCS therapy
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
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002537
