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

Gastric Cancer Clinical Trial

Official title:

Phase 2 Study of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Locally Advanced

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01090505
• Other study ID #: GC-ChinaPLAGH-2010
• Status: Recruiting
• Phase: Phase 2
• First received: March 16, 2010
• Last updated: March 19, 2010
• Start date: November 2009
• Est. completion date: December 2015

Study information

• Verified date: November 2009
• Source: Chinese PLA General Hospital
• Contact: L Chen, MD
• Phone: 86-10-66938028
• Email: litbj301[@]sina.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 2015
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	China PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		5 years	Yes
Secondary	response rate		3 months	Yes