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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier:
NCT01206218
First received: September 20, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Customized Treatment According to BRCA1 Assessment in Patients With Advanced Gastric Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School:

Primary Outcome Measures:
  • Progression-free Survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Response Rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 96
Study Start Date: October 2010
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 20, 2010
Last Updated: September 20, 2010
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013