Study of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer
Phase 2 Study of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Locally Advanced
1 other identifier
interventional
160
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 gastric-cancer
Started Nov 2009
Longer than P75 for phase_2 gastric-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 16, 2010
CompletedFirst Posted
Study publicly available on registry
March 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMarch 22, 2010
November 1, 2009
3.1 years
March 16, 2010
March 19, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
overall survival
5 years
Secondary Outcomes (1)
response rate
3 months
Study Arms (2)
Drug:S-1:80mg/m2;oxaliplatin 130mg/m2
EXPERIMENTALDrug: Neoadjuvant chemotherapy(S-1+Oxaliplatin) followed by D2 gastrectomy
surgery
NO INTERVENTIONProcedure/Surgery: Gastrectomy with D2 dissection
Interventions
Drug:S-1:80mg/m2;oxaliplatin 130mg/m2
Eligibility Criteria
You may qualify if:
- DISEASE CHARACTERISTICS:
- Histologically confirmed gastric adenocarcinoma Locally advanced disease:Clinical stage T3-4, N0-3, M0 (according to the Japanese gastric cancer classification)
- Planning to undergo gastric cancer D2 surgery after neoadjuvant chemotherapy
- Age:20 to 75
- Performance status:ECOG 0-2
- Life expectancy:Not specified
- 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
- Adequate organ function
- Able to swallow oral medication
- Written informed consent
You may not qualify if:
- Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
- Pregnant or breast-feeding women
- Severe mental disease
- Systemic administration of corticosteroids, flucytosine, phenytoin or warfarin
- Other severe complications such as paralytic ileus, intestinal pneumonitis, pulmonary fibrosis, or ischemic heart disease
- Myocardial infarction within six disease-free months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China PLA General Hospital
Beijing, Beijing Municipality, 100853, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 16, 2010
First Posted
March 22, 2010
Study Start
November 1, 2009
Primary Completion
December 1, 2012
Study Completion
December 1, 2015
Last Updated
March 22, 2010
Record last verified: 2009-11