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

Chinese PLA General Hospital (301 Hospital)

Status and phase: Unknown; Phase 2

Conditions: Gastric Cancer

Treatments: Drug: Drug: S-1 and oxaliplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01090505

GC-ChinaPLAGH-2010

Details and patient eligibility

About

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

Enrollment: 160 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Drug: Drug: S-1 and oxaliplatin

surgery

No Intervention group

Description:

Procedure/Surgery: Gastrectomy with D2 dissection

Treatment:

Drug: Drug: S-1 and oxaliplatin