search
Back to results

Study of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Drug: S-1 and oxaliplatin
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. DISEASE CHARACTERISTICS:

    Histologically confirmed gastric adenocarcinoma Locally advanced disease:Clinical stage T3-4, N0-3, M0 (according to the Japanese gastric cancer classification)

  2. Planning to undergo gastric cancer D2 surgery after neoadjuvant chemotherapy
  3. Age:20 to 75
  4. Performance status:ECOG 0-2
  5. Life expectancy:Not specified
  6. Hematopoietic:WBC 4,000-12,000/mm^3；Granulocyte count ≥ 2,000/mm^3；Platelet count ≥ 100,000/mm^3；Hemoglobin ≥ 9.0 g/dL;Hepatic:AST and ALT ≤ 100 U/L；Bilirubin ≤ 1.5 mg/dL
  7. Adequate organ function
  8. Able to swallow oral medication
  9. Written informed consent

Exclusion Criteria:

  1. Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
  2. Pregnant or breast-feeding women
  3. Severe mental disease
  4. Systemic administration of corticosteroids, flucytosine, phenytoin or warfarin
  5. Other severe complications such as paralytic ileus, intestinal pneumonitis, pulmonary fibrosis, or ischemic heart disease
  6. Myocardial infarction within six disease-free months

Sites / Locations

  • China PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Drug:S-1:80mg/m2;oxaliplatin 130mg/m2

surgery

Arm Description

Drug: Neoadjuvant chemotherapy(S-1+Oxaliplatin) followed by D2 gastrectomy

Procedure/Surgery: Gastrectomy with D2 dissection

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

response rate

Full Information

First Posted
March 16, 2010
Last Updated
March 19, 2010
Sponsor
Chinese PLA General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01090505
Brief Title
Study of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer
Official Title
Phase 2 Study of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Locally Advanced
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether S-1 and oxaliplatin as neoadjuvant chemotherapy may improve survival benefit compared with control.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Drug:S-1:80mg/m2;oxaliplatin 130mg/m2
Arm Type
Experimental
Arm Description
Drug: Neoadjuvant chemotherapy(S-1+Oxaliplatin) followed by D2 gastrectomy
Arm Title
surgery
Arm Type
No Intervention
Arm Description
Procedure/Surgery: Gastrectomy with D2 dissection
Intervention Type
Drug
Intervention Name(s)
Drug: S-1 and oxaliplatin
Other Intervention Name(s)
S-1:Taiho, Oxaliplatin：sanofi-aventis
Intervention Description
Drug:S-1:80mg/m2;oxaliplatin 130mg/m2
Primary Outcome Measure Information:
Title
overall survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
response rate
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: DISEASE CHARACTERISTICS: Histologically confirmed gastric adenocarcinoma Locally advanced disease:Clinical stage T3-4, N0-3, M0 (according to the Japanese gastric cancer classification) Planning to undergo gastric cancer D2 surgery after neoadjuvant chemotherapy Age:20 to 75 Performance status:ECOG 0-2 Life expectancy:Not specified Hematopoietic:WBC 4,000-12,000/mm^3；Granulocyte count ≥ 2,000/mm^3；Platelet count ≥ 100,000/mm^3；Hemoglobin ≥ 9.0 g/dL;Hepatic:AST and ALT ≤ 100 U/L；Bilirubin ≤ 1.5 mg/dL Adequate organ function Able to swallow oral medication Written informed consent Exclusion Criteria: Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ Pregnant or breast-feeding women Severe mental disease Systemic administration of corticosteroids, flucytosine, phenytoin or warfarin Other severe complications such as paralytic ileus, intestinal pneumonitis, pulmonary fibrosis, or ischemic heart disease Myocardial infarction within six disease-free months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
L Chen, MD
Phone
86-10-66938028
Email
litbj301@sina.com
Facility Information:
Facility Name
China PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fu xing road 28#
Phone
86-10-66938328

12. IPD Sharing Statement

Learn more about this trial

Study of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer

We'll reach out to this number within 24 hrs