NCT00320294

Brief Summary

To compare the combination of irinotecan, leucovorin and 5-FU (ILF) with ILF plus cisplatin (PILF) as first-line chemotherapy in patients with measurable metastatic gastric cancer.

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
86

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2005

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

February 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2006

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

March 12, 2007

Status Verified

March 1, 2007

First QC Date

May 1, 2006

Last Update Submit

March 9, 2007

Conditions

Stomach Neoplasm

Outcome Measures

Primary Outcomes (2)

  • Objective response rate

  • Safety

Secondary Outcomes (3)

  • Progression-free survival

  • Overall survival

  • Quality of life

Interventions

irinotecanDRUG
cisplatinDRUG

Eligibility Criteria

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

You may qualify if:

  • Histologically proven gastric adenocarcinoma
  • Advanced, metastatic or recurrent
  • ECOG performance status 0 to 2
  • No prior chemotherapy
  • Measurable or evaluable indicator lesion(s)
  • Normal marrow, hepatic and renal functions
  • Provision of written informed consent

You may not qualify if:

  • Active infection, bleeding or severe comorbidities
  • Pregnant or breastfed women
  • Active CNS metastasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gachon University Gil Medical Center

Incheon, 405 760, South Korea

Location

Related Publications (1)

  • Park SH, Nam E, Park J, Cho EK, Shin DB, Lee JH, Lee WK, Chung M, Lee SI. Randomized phase II study of irinotecan, leucovorin and 5-fluorouracil (ILF) versus cisplatin plus ILF (PILF) combination chemotherapy for advanced gastric cancer. Ann Oncol. 2008 Apr;19(4):729-33. doi: 10.1093/annonc/mdm502. Epub 2007 Dec 13.

    PMID: 18083691DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

IrinotecanCisplatin

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Se Hoon Park, MD

    Gachon University Gil Medical Center, Incheon, Korea

    PRINCIPAL INVESTIGATOR

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

May 1, 2006

First Posted

May 3, 2006

Study Start

February 1, 2005

Study Completion

March 1, 2007

Last Updated

March 12, 2007

Record last verified: 2007-03

Locations

KR(1)