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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2007 by National Cancer Center, Korea.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00587145
First Posted: January 7, 2008
Last Update Posted: January 7, 2008
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.
Information provided by:
National Cancer Center, Korea
  Purpose

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

Condition Intervention Phase
Stomach Neoplasms Drug: S-1,Docetaxel Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Perioperative S-1 Plus Docetaxel in Patients With Localized Advanced Gastric Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • To evaluate the clinical responses to preoperative S-1 plus docetaxel [ Time Frame: During chemotherapy ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 44
Study Start Date: May 2006
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00587145


Contacts
Contact: Sook Ryun Park, M.D +82-31-920-1609 sukryun73@ncc.re.kr
Contact: So Yun Park, MS +82-31-920-2307 tomongmong@naver.com

Locations
Korea, Republic of
National Cancer Center Korea Recruiting
Goyang,, Gyeonggi, Korea, Republic of
Contact: Sook Ryun Park, M.D    +82-31-920-1609    sukryun73@ncc.re.kr   
Contact: So Yun Park, MS    +82-31-920-2307    tomongmong@naver.com   
Sub-Investigator: Noe Kyeong Kim, M.D         
Sub-Investigator: Young Iee Park Park, M.D.Ph.D         
Sub-Investigator: Young Woo Kim,, M.D         
Sub-Investigator: Keun Won Ryu, M.D         
Sub-Investigator: Jun Ho Lee, M.D         
Sub-Investigator: Il Ju Choi, M.D         
Sub-Investigator: Chan Gyoo Kim, M.D         
Sub-Investigator: Jong-Yeul Lee, M.D         
Sub-Investigator: Jong Seok Lee, M.D         
Sub-Investigator: Myeong-Cherl Kook Kook, M.D         
Sub-Investigator: Hyeong-Seok Lim, M.D         
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: Sook Ryun Park, M.D National Cancer Center, Korea
  More Information

Responsible Party: Sook Ryun Park, M.D., National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT00587145     History of Changes
Other Study ID Numbers: NCCCTS-06-190
82-31-920-1609
First Submitted: December 21, 2007
First Posted: January 7, 2008
Last Update Posted: January 7, 2008
Last Verified: December 2007

Keywords provided by National Cancer Center, Korea:
Stomach Neoplasms
Secondary
Combination chemotherapy
S-1
Docetaxel
oxaliplatin

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action