Status:

UNKNOWN

Evaluation of Customized Treatment According to BRCA1 Assessment in Patients With Advanced Gastric Cancer

Lead Sponsor:

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Conditions:

Advanced Gastric Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

PHASE3

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

October 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

Estimated Enrollment :

96 Patients enrolled

Trial Details

Trial ID

NCT01206218

Start Date

October 1 2010

Last Update

September 21 2010

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