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Evaluation of Customized Treatment According to BRCA1 Assessment in Patients With Advanced Gastric Cancer
Conditions
Advanced Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
Gastric Cancer, BRCA1
Study Type
Interventional
Study Phase
Phase 2/Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: FLOT Regimen
Type: Drug
Name: FLO Regimen or FLOT Regimen
Type: Drug
Overall Status
Not yet recruiting
Summary
Evaluation of customized treatment according to BRCA1 assessment in patients with advanced gastric cancer
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:
- Provision of informed consent
- 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:
- Have at least another primary malignant tumor
- 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
- Provision of informed consent
- 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:
- Have at least another primary malignant tumor
- 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
Location
Start Date
October 2010
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Source
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page