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

Primary Purpose

Stomach Neoplasms

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
S-1,Docetaxel
Sponsored by
National Cancer Center, Korea
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Neoplasms focused on measuring Stomach Neoplasms, Secondary, Combination chemotherapy, S-1, Docetaxel, oxaliplatin

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Cancer Center KoreaRecruiting

Outcomes

Primary Outcome Measures

To evaluate the clinical responses to preoperative S-1 plus docetaxel

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

Full Information

First Posted
December 21, 2007
Last Updated
December 21, 2007
Sponsor
National Cancer Center, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT00587145
Brief Title
Phase II Study of Perioperative S-1 Plus Docetaxel in Patients With Localized Advanced Gastric Cancer
Official Title
Phase II Study of Perioperative S-1 Plus Docetaxel in Patients With Localized Advanced Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Unknown status
Study Start Date
May 2006 (undefined)
Primary Completion Date
March 2009 (Anticipated)
Study Completion Date
May 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Center, Korea

4. Oversight

Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms
Keywords
Stomach Neoplasms, Secondary, Combination chemotherapy, S-1, Docetaxel, oxaliplatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
S-1,Docetaxel
Intervention 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
Primary Outcome Measure Information:
Title
To evaluate the clinical responses to preoperative S-1 plus docetaxel
Time Frame
During chemotherapy
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sook Ryun Park, M.D
Phone
+82-31-920-1609
Email
sukryun73@ncc.re.kr
First Name & Middle Initial & Last Name or Official Title & Degree
So Yun Park, MS
Phone
+82-31-920-2307
Email
tomongmong@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sook Ryun Park, M.D
Organizational Affiliation
National Cancer Center, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center Korea
City
Goyang,
State/Province
Gyeonggi
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sook Ryun Park, M.D
Phone
+82-31-920-1609
Email
sukryun73@ncc.re.kr
First Name & Middle Initial & Last Name & Degree
So Yun Park, MS
Phone
+82-31-920-2307
Email
tomongmong@naver.com
First Name & Middle Initial & Last Name & Degree
Noe Kyeong Kim, M.D
First Name & Middle Initial & Last Name & Degree
Young Iee Park Park, M.D.Ph.D
First Name & Middle Initial & Last Name & Degree
Young Woo Kim,, M.D
First Name & Middle Initial & Last Name & Degree
Keun Won Ryu, M.D
First Name & Middle Initial & Last Name & Degree
Jun Ho Lee, M.D
First Name & Middle Initial & Last Name & Degree
Il Ju Choi, M.D
First Name & Middle Initial & Last Name & Degree
Chan Gyoo Kim, M.D
First Name & Middle Initial & Last Name & Degree
Jong-Yeul Lee, M.D
First Name & Middle Initial & Last Name & Degree
Jong Seok Lee, M.D
First Name & Middle Initial & Last Name & Degree
Myeong-Cherl Kook Kook, M.D
First Name & Middle Initial & Last Name & Degree
Hyeong-Seok Lim, M.D

12. IPD Sharing Statement

Learn more about this trial

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

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