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

Primary Purpose

Advanced Gastric Cancer

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
FLOT Regimen
FLO Regimen or FLOT Regimen
Sponsored by
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Gastric Cancer focused on measuring Gastric Cancer, BRCA1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Group A

    Group B

    Arm Description

    FLOT Regimen

    FLO Regimen or FLOT Regimen

    Outcomes

    Primary Outcome Measures

    Progression-free Survival

    Secondary Outcome Measures

    Overall Survival
    Response Rate

    Full Information

    First Posted
    September 20, 2010
    Last Updated
    September 20, 2010
    Sponsor
    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01206218
    Brief Title
    Evaluation of Customized Treatment According to BRCA1 Assessment in Patients With Advanced Gastric Cancer
    Acronym
    BREC-AGC
    Official Title
    Evaluation of Customized Treatment According to BRCA1 Assessment in Patients With Advanced Gastric Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2010
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2010 (undefined)
    Primary Completion Date
    October 2012 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Advanced Gastric Cancer
    Keywords
    Gastric Cancer, BRCA1

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    96 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Active Comparator
    Arm Description
    FLOT Regimen
    Arm Title
    Group B
    Arm Type
    Experimental
    Arm Description
    FLO Regimen or FLOT Regimen
    Intervention Type
    Drug
    Intervention Name(s)
    FLOT Regimen
    Intervention Description
    FLOT Regimen: 5-fluorouracil, Oxaliplatin, Docetaxel
    Intervention Type
    Drug
    Intervention Name(s)
    FLO Regimen or FLOT Regimen
    Intervention Description
    FLO Regimen: 5-fluorouracil, Oxaliplatin FLOT Regimen: 5-fluorouracil, Oxaliplatin, Docetaxel
    Primary Outcome Measure Information:
    Title
    Progression-free Survival
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Overall Survival
    Time Frame
    12 months
    Title
    Response Rate
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Baorui Liu, MD, PHD
    Phone
    (86)13770621908
    Email
    baoruiliu@nju.edu.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jia Wei, MD, PHD
    Phone
    (86)13951785234
    Email
    weijia01627@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Baorui Liu, MD, PHD
    Organizational Affiliation
    Drum Tower Hospital, Nanjing University Medical School
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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

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