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

NCT ID: NCT01090505

Last Updated: 2010-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2015-12-31

Brief Summary

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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

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Conditions

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Gastric Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

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

Group Type EXPERIMENTAL

Drug: S-1 and oxaliplatin

Intervention Type DRUG

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

surgery

Procedure/Surgery: Gastrectomy with D2 dissection

Group Type NO_INTERVENTION

Drug: S-1 and oxaliplatin

Intervention Type DRUG

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

Interventions

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Drug: S-1 and oxaliplatin

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

Intervention Type DRUG

Other Intervention Names

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S-1:Taiho Oxaliplatin:sanofi-aventis

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chinese PLA General Hospital

Locations

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China PLA General Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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L Chen, MD

Role: CONTACT

86-10-66938028

Facility Contacts

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Fu xing road 28#

Role: primary

86-10-66938328

Other Identifiers

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GC-ChinaPLAGH-2010

Identifier Type: -

Identifier Source: org_study_id

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