Evaluation of Customized Treatment According to BRCA1 Assessment in Patients With Advanced Gastric Cancer
NCT ID: NCT01206218
Last Updated: 2010-09-21
Study Results
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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UNKNOWN
PHASE2/PHASE3
96 participants
INTERVENTIONAL
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
FLOT Regimen
FLOT Regimen
FLOT Regimen: 5-fluorouracil, Oxaliplatin, Docetaxel
Group B
FLO Regimen or FLOT Regimen
FLO Regimen or FLOT Regimen
FLO Regimen: 5-fluorouracil, Oxaliplatin FLOT Regimen: 5-fluorouracil, Oxaliplatin, Docetaxel
Interventions
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FLOT Regimen
FLOT Regimen: 5-fluorouracil, Oxaliplatin, Docetaxel
FLO Regimen or FLOT Regimen
FLO Regimen: 5-fluorouracil, Oxaliplatin FLOT Regimen: 5-fluorouracil, Oxaliplatin, Docetaxel
Eligibility Criteria
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Inclusion Criteria
* Female or male aged 18 years and over
* Histologic or cytologic confirmation of advanced gastric cancer
* Stage III-IV (AJCC 7th)
* ECOG: 0-2
* Have tumor sample that can be tested for BRCA1 mRNA expression
* Negative pregnancy test for women of childbearing potential
* Neutrophile granulocyte greater than 1.5×10\^9/L
* Hemoglobin greater than 10g/dL
* Platelet greater than 100×10\^9/L
* Serum bilirubin not greater than 1.5x upper limit of reference range (ULRR)
* ALT or AST not greater than 1.5x ULRR
* Creatinine clearance no less than 60ml/min
Exclusion Criteria
* Active infection
* Chemotherapy with experimental drug within 3 weeks before the start of study therapy
* Women who are pregnant or breast feeding
* Weight loss greater 10% within 6 weeks before the start of study therapy
18 Years
ALL
No
Sponsors
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Responsible Party
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The Comprehensive Cancer Center of Drum Tower Hospital, Nanjing University Medical School
Principal Investigators
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Baorui Liu, MD, PHD
Role: PRINCIPAL_INVESTIGATOR
Drum Tower Hospital, Nanjing University Medical School
Central Contacts
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Other Identifiers
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BREC-AGC
Identifier Type: -
Identifier Source: org_study_id