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

Sponsor

National Cancer Center, Korea (Other)

Overall Status

Unknown status

CT.gov ID

NCT00587145

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Stomach Neoplasms	Drug: S-1,Docetaxel	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

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

Study Start Date :

May 1, 2006

Anticipated Primary Completion Date :

Mar 1, 2009

Anticipated Study Completion Date :

May 1, 2009

Outcome Measures

Primary Outcome Measures

To evaluate the clinical responses to preoperative S-1 plus docetaxel [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 [During study period]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.