NCT01206218

Brief Summary

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

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2010

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Last Updated

September 21, 2010

Status Verified

September 1, 2010

Enrollment Period

2 years

First QC Date

September 20, 2010

Last Update Submit

September 20, 2010

Conditions

Advanced Gastric Cancer

Keywords

Gastric Cancer, BRCA1

Outcome Measures

Primary Outcomes (1)

  • Progression-free Survival

    12 months

Secondary Outcomes (2)

  • Overall Survival

    12 months

  • Response Rate

    12 months

Study Arms (2)

Group A

ACTIVE COMPARATOR

FLOT Regimen

Drug: FLOT Regimen

Group B

EXPERIMENTAL

FLO Regimen or FLOT Regimen

Drug: FLO Regimen or FLOT Regimen

Interventions

FLOT RegimenDRUG

FLOT Regimen: 5-fluorouracil, Oxaliplatin, Docetaxel

Group A
FLO Regimen or FLOT RegimenDRUG

FLO Regimen: 5-fluorouracil, Oxaliplatin FLOT Regimen: 5-fluorouracil, Oxaliplatin, Docetaxel

Group B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Baorui Liu, MD, PHD

    Drum Tower Hospital, Nanjing University Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Baorui Liu, MD, PHD

CONTACT

(86)13770621908baoruiliu@nju.edu.cn

Jia Wei, MD, PHD

CONTACT

(86)13951785234weijia01627@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 20, 2010

First Posted

September 21, 2010

Study Start

October 1, 2010

Primary Completion

October 1, 2012

Last Updated

September 21, 2010

Record last verified: 2010-09