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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by National Cancer Center, Korea.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT00587145
First received: December 21, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 21, 2007
Last Updated: December 21, 2007
Health Authority: Korea: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 23, 2014