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

Phase 2

• Conditions: Gastric Cancer

• Registration Number: NCT01090505
• Lead Sponsor: Chinese PLA General Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-11
• Study Start: 2009-11
• Study First Submitted: 2010-03-16
• Study First Submitted QC: 2010-03-19
• Last Update Submitted: 2010-03-19
• Study First Posted: 2010-03-22
• Last Update Posted: 2010-03-22
• Primary Completion: 2012-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
overall survival	5 years

Secondary Outcome Measures

Name	Time	Method
response rate	3 months

Trial Locations

Locations (1)

China PLA General Hospital; 🇨🇳 Beijing, Beijing, China