Phase II Study of Perioperative S-1 Plus Docetaxel in Pat... | NCT00587145 | Trialant
NCT00587145
Sponsor
National Cancer Center, Korea
Status
Unknown status
Last Update Posted
Jan 7, 2008Estimated
Enrollment
44Estimated
Phase
Phase 2
Conditions
Stomach Neoplasms
Interventions
S-1,Docetaxel
Countries
South Korea
Protocol Section
Identification Module
NCT ID
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT00587145
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
NCCCTS-06-190
Secondary IDs
ID
Type
Description
Link
82-31-920-1609
Brief Title
Phase II Study of Perioperative S-1 Plus Docetaxel in Patients With Localized Advanced Gastric Cancer
Official Title
Phase II Study of Perioperative S-1 Plus Docetaxel in Patients With Localized Advanced Gastric Cancer
Acronym
Not provided
Organization
National Cancer Center, KoreaOTHER_GOV
Status Module
Record Verification Date
Dec 2007
Overall Recruitment Status or Expanded Access Status
Unknown status
Last Known Status
Recruiting
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 2006
Primary Completion Date
Mar 2009Estimated
Completion Date
May 2009Estimated
First Submitted Date
Dec 21, 2007
First Submission Date that Met QC Criteria
Dec 21, 2007
First Posted Date
Jan 7, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 21, 2007
Last Update Posted Date
Jan 7, 2008Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
National Cancer Center, KoreaOTHER_GOV
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study is an open-label, single center, and a single arm phase II study to evaluate the clinical response and safety of perioperative S-1 plus docetaxel. Perioperative chemotherapy is composed of 3 cycles of preoperative S-1/docetaxel and 3 cycles of postoperative S-1/docetaxel.Chemotherapy regimen:
S-1 80 mg/m2/day every 12-h p.o. on days 1(evening)-15 (morning)
Docetaxel 35 mg/m2 mixed in d5w 250 ml iv over 60-min on days 1 and 8
Detailed Description
Not provided
Conditions Module
Conditions
Stomach Neoplasms
Keywords
Stomach Neoplasms
Secondary
Combination chemotherapy
S-1
Docetaxel
oxaliplatin
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
44Estimated
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
S-1,Docetaxel
Drug
S-1 80 mg/m2/day every 12-h p.o. on days 1(evening)-15 (morning)
Docetaxel 35 mg/m2 mixed in d5w 250 ml iv over 60-min on days 1 and 8
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
To evaluate the clinical responses to preoperative S-1 plus docetaxel
During chemotherapy
Secondary Outcomes
Measure
Description
Time Frame
the clinical downstaging,the pathologic responses, toxicity profile,the disease-free survival,overall survival,the effect of CYP2A6 genetic polymorphisms on the pharmacokinetics and the difference in pharmacokinetics between before and after gastrectomy
During study period
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed localized gastric adenocarcinoma as defined by CT stage III and IV (M0) (but not N3, which is metastatic node in WHO TNM classification), according to Japanese TNM classification system
No distant metastatic disease in laparoscopy
Age: 18-70 years
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Disease status must be that of measurable disease as defined by RECIST: Measurable lesions: lesions that can be accurately measured in at least one dimension by abdominal CT, if the longest diameter to be recorded is at least 10 mm with spiral CT
Adequate major organ function including the following: Hematopoietic function: WBC ³ 4,000/mm3, ANC ³ 1,500/mm3, Platelet ³ 100,000/mm3Hepatic function: serum bilirubin £ 1.5 mg/dl, AST/ALT levels £ 2.5 x UNLRenal function: serum creatinine £ 1.5 mg/dl
Patients should sign a written informed consent before study entry
Exclusion Criteria:
CT Stage I, II, M1 or N3, which is metastatic node in WHO TNM classification, according to Japanese TNM classification system
Prior chemotherapy or radiotherapy
Inadequate cardiovascular function:New York Heart Association class III or IV heart diseaseUnstable angina or myocardial infarction within the past 6 monthsHistory of significant ventricular arrhythmia requiring medication with antiarrhythmics or significant conduction system abnormality
Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy
Other malignancy within the past 3 years except non-melanomatous skin cancer or carcinoma in situ of the cervix
Psychiatric disorder that would preclude compliance
Pregnant, nursing women or patients with reproductive potential without contraception
Patients receiving a concomitant treatment with drugs interacting with S-1 such as flucytosine, phenytoin, or warfarin et al.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
70 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Name
Role
Phone
Extension
Email
Sook Ryun Park, M.D
Contact
+82-31-920-1609
sukryun73@ncc.re.kr
So Yun Park, MS
Contact
+82-31-920-2307
tomongmong@naver.com
Overall Officials
Name
Affiliation
Role
Sook Ryun Park, M.D
National Cancer Center, Korea
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
National Cancer Center Korea
Recruiting
Goyang-si
Gyeonggi-do
South Korea
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D013274
Stomach Neoplasms
D009362
Neoplasm Metastasis
Ancestor Terms
ID
Term
D005770
Gastrointestinal Neoplasms
D004067
Digestive System Neoplasms
D009371
Neoplasms by Site
D009369
Neoplasms
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
No data available
No data is available for this block.
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Sook Ryun Park, M.DContact+82-31-920-1609sukryun73@ncc.re.kr
So Yun Park, MSContact+82-31-920-2307tomongmong@naver.com