NCT00587145

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 7, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

January 7, 2008

Status Verified

December 1, 2007

Enrollment Period

2.8 years

First QC Date

December 21, 2007

Last Update Submit

December 21, 2007

Conditions

Stomach Neoplasms

Keywords

Stomach NeoplasmsSecondaryCombination chemotherapyS-1Docetaxeloxaliplatin

Outcome Measures

Primary Outcomes (1)

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

    During chemotherapy

Secondary Outcomes (1)

  • 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

Interventions

S-1,DocetaxelDRUG

* 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 Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center Korea

Goyang-si, Gyeonggi-do, South Korea

RECRUITING

MeSH Terms

Conditions

Stomach NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sook Ryun Park, M.D

    National Cancer Center, Korea

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sook Ryun Park, M.D

CONTACT

+82-31-920-1609sukryun73@ncc.re.kr

So Yun Park, MS

CONTACT

+82-31-920-2307tomongmong@naver.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 7, 2008

Study Start

May 1, 2006

Primary Completion

March 1, 2009

Study Completion

May 1, 2009

Last Updated

January 7, 2008

Record last verified: 2007-12

Locations

KR(1)