ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase II Study of Perioperative S-1 Plus Docetaxel in Patients With Localized Advanced Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00587145
Recruitment Status : Unknown
Verified December 2007 by National Cancer Center, Korea.
Recruitment status was:  Recruiting
First Posted : January 7, 2008
Last Update Posted : January 7, 2008
Sponsor:
Information provided by:
National Cancer Center, Korea

December 21, 2007
January 7, 2008
January 7, 2008
May 2006
March 2009   (Final data collection date for primary outcome measure)
To evaluate the clinical responses to preoperative S-1 plus docetaxel [ Time Frame: During chemotherapy ]
Same as current
No Changes Posted
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 [ Time Frame: During study period ]
Same as current
Not Provided
Not Provided
 
Phase II Study of Perioperative S-1 Plus Docetaxel in Patients With Localized Advanced Gastric Cancer
Phase II Study of Perioperative S-1 Plus Docetaxel in Patients With Localized Advanced Gastric Cancer

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
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Stomach Neoplasms
Drug: S-1,Docetaxel
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
44
Same as current
May 2009
March 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 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
  2. No distant metastatic disease in laparoscopy
  3. Age: 18-70 years
  4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  5. 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
  6. 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
  7. Patients should sign a written informed consent before study entry

Exclusion Criteria:

  1. CT Stage I, II, M1 or N3, which is metastatic node in WHO TNM classification, according to Japanese TNM classification system
  2. Prior chemotherapy or radiotherapy
  3. 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
  4. Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy
  5. Other malignancy within the past 3 years except non-melanomatous skin cancer or carcinoma in situ of the cervix
  6. Psychiatric disorder that would preclude compliance
  7. Pregnant, nursing women or patients with reproductive potential without contraception
  8. Patients receiving a concomitant treatment with drugs interacting with S-1 such as flucytosine, phenytoin, or warfarin et al.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT00587145
NCCCTS-06-190
82-31-920-1609
No
Not Provided
Not Provided
Sook Ryun Park, M.D., National Cancer Center, Korea
National Cancer Center, Korea
Not Provided
Principal Investigator: Sook Ryun Park, M.D National Cancer Center, Korea
National Cancer Center, Korea
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP