NCT00510107

Brief Summary

To evaluate the efficacy and safety of weekly administered combination of docetaxel/cisplatin and docetaxel/oxaliplatin in chemotherapy-naïve patients with advanced gastric cancer. The primary endpoint will be the response rate.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2007

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

July 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 1, 2007

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

August 1, 2007

Status Verified

July 1, 2007

First QC Date

July 31, 2007

Last Update Submit

July 31, 2007

Conditions

Stomach NeoplasmStage IVRecurrent

Outcome Measures

Primary Outcomes (1)

  • response rate

Secondary Outcomes (1)

  • safety

Study Arms (2)

1

ACTIVE COMPARATOR

Docetaxel 35 mg/m2 will be administered on days 1 and 8. Cisplatin 60 mg/m2 will be administered on day 1 every 3 weeks.

Drug: Cisplatin

2

EXPERIMENTAL

Docetaxel 35 mg/m2 will be administered on days 1 and 8. Oxaliplatin 120 mg/m2 will be administered on day 1 every 3 weeks.

Drug: oxaliplatin

Interventions

oxaliplatinDRUG

oxaliplatin 120 mg/m2 will be given on day 1.

Also known as: Eloxatin
2
CisplatinDRUG

Cisplatin 60 mg/m2 will be given on day 1.

1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically proven gastric cancer
  • aged 75 years or less
  • performance status 0 to 2
  • no prior chemotherapy
  • inoperable, recurrent, or metastatic
  • normal marrow, hepatic and renal functions

You may not qualify if:

  • active infections
  • severe co-morbidities
  • pregnant or lactating women
  • active brain metastasis
  • neuropathy of grade 2 or higher

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gachon University Gil Medical Center

Incheon, Incheon, 405 760, South Korea

RECRUITING

MeSH Terms

Conditions

Stomach NeoplasmsRecurrence

Interventions

OxaliplatinCisplatin

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Se Hoon Park, MD

    Gachon University Gil Medical Center, Incheon, Korea

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Bok Shin, MD, PhD

CONTACT

82 32 460 3682dbs@gilhospital.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

July 31, 2007

First Posted

August 1, 2007

Study Start

July 1, 2007

Study Completion

July 1, 2009

Last Updated

August 1, 2007

Record last verified: 2007-07

Locations

KR(1)