CClinicalTrials.gg
Status unknownNCT00509964Updated Aug 1, 2007

Second-Line Irinotecan vs. ILF for AGC

A Phase 2 interventional study of irinotecan and ILF in Stomach Neoplasm, Metastatic and Second-Line, sponsored by Gachon University Gil Medical Center. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2007-08-01.

Sponsored by Gachon University Gil Medical Center · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2007), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Patients with recurrent or metastatic gastric cancer can benefit from palliative chemotherapy. However, over half of patients with metastatic gastric cancer who received chemotherapy failed to achieve response and even in these responders, the duration of responses was as short as a few months. Patients with metastatic gastric cancer who fail to respond or have relapse after first line chemotherapy have a grim prognosis and a standard salvage treatment is not available.

We designed this phase II trial to determine the efficacy and safety of irinotecan monotherapy or combination (ILF) as second-line therapy for advanced gastric cancer.

02

Conditions studied

  • Stomach Neoplasm
  • Metastatic
  • Second-Line

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03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's planned enrollment of 50 is below the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Gachon University Gil Medical Center is the lead sponsor of 88 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • histologically confirmed gastric cancer
  • inoperable, recurrent, or metastatic
  • performance status 0 to 2
  • failed after one or more prior chemotherapy for advanced disease
  • informed consent

Exclusion criteria

Exclusion Criteria:

  • active infection
  • severe co-morbidities
  • previously treated with irinotecan or similar drugs
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    1

    Patients will receive irinotecan 150 mg/m2 intravenously on day 1 every 2 weeks.

    Drug: irinotecan

  • Active comparator
    2

    Patients will receive irinotecan 150 mg/m2 intravenously, in combination with leucovorin and infusional 5-fluorouracil, on day 1 every 2 weeks.

    Drug: ILF

Interventions

  • Drugirinotecan

    Patients will receive irinotecan 150 mg/m2 intravenously on day 1 every 2 weeks.

  • DrugILF

    Patients will receive irinotecan 150 mg/m2 intravenously, in combination with leucovorin and 5-fluorouracil, on day 1 every 2 weeks.

06

What researchers measure

Primary outcomes

  1. response rate

Secondary outcomes

  1. safety

07

Study locations

1 of 1 sites recruiting
  • Gachon University Gil Medical Center
    Incheon, 405 760, Korea, Republic of
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00509964
Lead sponsor
Gachon University Gil Medical Center
First posted
Aug 1, 2007
Start date
May 2007
Completion
Jul 2007 (estimated)
Last update
Aug 1, 2007

Study contacts

Dong Bok Shin, MD, PhD
Contact
dbs@gilhospital.com
82 32 460 3682
Se Hoon Park, MD
principal investigator · Gachon University Gil Medical Center, Incheon, Korea

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2007. You cannot join it, but the record below documents what was studied.

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