To hear about similar clinical trials, please enter your email below
Trial Title:
Phase II Study of Perioperative S-1 Plus Docetaxel in Patients With Localized Advanced Gastric Cancer
NCT ID:
NCT00587145
Condition:
Stomach Neoplasms
Conditions: Official terms:
Stomach Neoplasms
Docetaxel
Conditions: Keywords:
Stomach Neoplasms
Secondary
Combination chemotherapy
S-1
Docetaxel
oxaliplatin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
S-1,Docetaxel
Description:
- 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
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
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cancer Center Korea
Address:
City:
Goyang,
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Sook Ryun Park, M.D
Phone:
+82-31-920-1609
Email:
sukryun73@ncc.re.kr
Contact backup:
Last name:
So Yun Park, MS
Phone:
+82-31-920-2307
Email:
tomongmong@naver.com
Investigator:
Last name:
Noe Kyeong Kim, M.D
Email:
Sub-Investigator
Investigator:
Last name:
Young Iee Park Park, M.D.Ph.D
Email:
Sub-Investigator
Investigator:
Last name:
Young Woo Kim,, M.D
Email:
Sub-Investigator
Investigator:
Last name:
Keun Won Ryu, M.D
Email:
Sub-Investigator
Investigator:
Last name:
Jun Ho Lee, M.D
Email:
Sub-Investigator
Investigator:
Last name:
Il Ju Choi, M.D
Email:
Sub-Investigator
Investigator:
Last name:
Chan Gyoo Kim, M.D
Email:
Sub-Investigator
Investigator:
Last name:
Jong-Yeul Lee, M.D
Email:
Sub-Investigator
Investigator:
Last name:
Jong Seok Lee, M.D
Email:
Sub-Investigator
Investigator:
Last name:
Myeong-Cherl Kook Kook, M.D
Email:
Sub-Investigator
Investigator:
Last name:
Hyeong-Seok Lim, M.D
Email:
Sub-Investigator
Start date:
May 2006
Completion date:
May 2009
Lead sponsor:
Agency:
National Cancer Center, Korea
Agency class:
Other
Source:
National Cancer Center, Korea
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00587145
