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Trial Title:
Evaluation of Customized Treatment According to BRCA1 Assessment in Patients With Advanced Gastric Cancer
NCT ID:
NCT01206218
Condition:
Advanced Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Conditions: Keywords:
Gastric Cancer, BRCA1
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
FLOT Regimen
Description:
FLOT Regimen: 5-fluorouracil, Oxaliplatin, Docetaxel
Arm group label:
Group A
Intervention type:
Drug
Intervention name:
FLO Regimen or FLOT Regimen
Description:
FLO Regimen: 5-fluorouracil, Oxaliplatin FLOT Regimen: 5-fluorouracil, Oxaliplatin,
Docetaxel
Arm group label:
Group B
Summary:
Evaluation of customized treatment according to BRCA1 assessment in patients with
advanced gastric cancer
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
October 2010
Lead sponsor:
Agency:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Agency class:
Other
Source:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01206218
