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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01206218
Recruitment Status : Unknown
Verified September 2010 by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Recruitment status was:  Not yet recruiting
First Posted : September 21, 2010
Last Update Posted : September 21, 2010
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Advanced Gastric Cancer Drug: FLOT Regimen Drug: FLO Regimen or FLOT Regimen Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Customized Treatment According to BRCA1 Assessment in Patients With Advanced Gastric Cancer
Study Start Date : October 2010
Estimated Primary Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Group A
FLOT Regimen
Drug: FLOT Regimen
FLOT Regimen: 5-fluorouracil, Oxaliplatin, Docetaxel
Experimental: Group B
FLO Regimen or FLOT Regimen
Drug: FLO Regimen or FLOT Regimen
FLO Regimen: 5-fluorouracil, Oxaliplatin FLOT Regimen: 5-fluorouracil, Oxaliplatin, Docetaxel


Outcome Measures

Primary Outcome Measures :
  1. Progression-free Survival [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 12 months ]
  2. Response Rate [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01206218


Contacts
Contact: Baorui Liu, MD, PHD (86)13770621908 baoruiliu@nju.edu.cn
Contact: Jia Wei, MD, PHD (86)13951785234 weijia01627@hotmail.com

Sponsors and Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Investigators
Principal Investigator: Baorui Liu, MD, PHD Drum Tower Hospital, Nanjing University Medical School
More Information

Responsible Party: Baorui Liu, The Comprehensive Cancer Center of Drum Tower Hospital, Nanjing University Medical School
ClinicalTrials.gov Identifier: NCT01206218     History of Changes
Other Study ID Numbers: BREC-AGC
First Posted: September 21, 2010    Key Record Dates
Last Update Posted: September 21, 2010
Last Verified: September 2010

Keywords provided by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School:
Gastric Cancer, BRCA1

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases