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Trial Title:
Study of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer
NCT ID:
NCT01090505
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Oxaliplatin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Drug: S-1 and oxaliplatin
Description:
Drug:S-1:80mg/m2;oxaliplatin 130mg/m2
Arm group label:
Drug:S-1:80mg/m2;oxaliplatin 130mg/m2
Arm group label:
surgery
Other name:
S-1:Taiho
Other name:
Oxaliplatin：sanofi-aventis
Summary:
The purpose of this study is to determine whether S-1 and oxaliplatin as neoadjuvant
chemotherapy may improve survival benefit compared with control.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
20 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
China PLA General Hospital
Address:
City:
Beijing
Zip:
100853
Country:
China
Status:
Recruiting
Contact:
Last name:
Fu xing road 28#
Phone:
86-10-66938328
Start date:
November 2009
Completion date:
December 2015
Lead sponsor:
Agency:
Chinese PLA General Hospital
Agency class:
Other
Source:
Chinese PLA General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01090505
