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

Study Overview

• Status: Unknown
• Conditions: Stomach Neoplasms
• Intervention / Treatment: Drug: S-1,Docetaxel

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi
    • Goyang,, Gyeonggi, Korea, Republic of
      • Recruiting
      • National Cancer Center Korea
      • Contact: Sook Ryun Park, M.D; Phone Number: +82-31-920-1609; Email: sukryun73@ncc.re.kr
      • Contact: So Yun Park, MS; Phone Number: +82-31-920-2307; Email: 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate the clinical responses to preoperative S-1 plus docetaxel	During chemotherapy

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: National Cancer Center, Korea
• Investigators: Principal Investigator: Sook Ryun Park, M.D, National Cancer Center, Korea

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Anticipated): March 1, 2009
• Study Completion (Anticipated): May 1, 2009

Study Registration Dates

• First Submitted: December 21, 2007
• First Submitted That Met QC Criteria: December 21, 2007
• First Posted (Estimate): January 7, 2008

Study Record Updates

• Last Update Posted (Estimate): January 7, 2008
• Last Update Submitted That Met QC Criteria: December 21, 2007
• Last Verified: December 1, 2007

More Information

Terms related to this study

• Keywords: Docetaxel; oxaliplatin; Combination chemotherapy; S-1; Secondary; Stomach Neoplasms
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: NCCCTS-06-190; 82-31-920-1609