Evaluation of Customized Treatment According to BRCA1 Assessment in Patients With Advanced Gastric Cancer (BREC-AGC)

Nanjing University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Advanced Gastric Cancer

Treatments: Drug: FLOT Regimen; Drug: FLO Regimen or FLOT Regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT01206218

BREC-AGC

Details and patient eligibility

About

Evaluation of customized treatment according to BRCA1 assessment in patients with advanced gastric cancer

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

Group A

Active Comparator group

Description:

FLOT Regimen

Treatment:

Drug: FLOT Regimen

Group B

Experimental group

Description:

FLO Regimen or FLOT Regimen

Treatment:

Drug: FLO Regimen or FLOT Regimen