Advanced Gastric Cancer
Conditions
Keywords
Gastric Cancer, BRCA1
Brief summary
Evaluation of customized treatment according to BRCA1 assessment in patients with advanced gastric cancer
Interventions
DRUGFLOT Regimen
FLOT Regimen: 5-fluorouracil, Oxaliplatin, Docetaxel
DRUGFLO Regimen or FLOT Regimen
FLO Regimen: 5-fluorouracil, Oxaliplatin FLOT Regimen: 5-fluorouracil, Oxaliplatin, Docetaxel
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival | 12 months |
| Response Rate | 12 months |
Contacts
Primary ContactBaorui Liu, MD, PHD
Backup ContactJia Wei, MD, PHD
Outcome results
None listed