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

Advanced Gastric Cancer Clinical Trial

— BREC-AGC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01206218
• Other study ID #: BREC-AGC
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: September 20, 2010
• Last updated: September 20, 2010
• Start date: October 2010

Study information

• Verified date: September 2010
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Baorui Liu, MD, PHD
• Phone: (86)13770621908
• Email: baoruiliu[@]nju.edu.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• FLOT Regimen
FLOT Regimen: 5-fluorouracil, Oxaliplatin, Docetaxel
• FLO Regimen or FLOT Regimen
FLO Regimen: 5-fluorouracil, Oxaliplatin FLOT Regimen: 5-fluorouracil, Oxaliplatin, Docetaxel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival		12 months	No
Secondary	Overall Survival		12 months	No
Secondary	Response Rate		12 months	No