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A Randomized Phase II Trial of Irinotecan Monotherapy Versus Irinotecan, Leucovorin and 5-FU (ILF) Combination Chemotherapy in Patients With Advanced Gastric Cancer Failing Prior Chemotherapy


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Stomach Neoplasm, Metastatic, Second-Line

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Trial Information

A Randomized Phase II Trial of Irinotecan Monotherapy Versus Irinotecan, Leucovorin and 5-FU (ILF) Combination Chemotherapy in Patients With Advanced Gastric Cancer Failing Prior Chemotherapy


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:

- active infection

- severe co-morbidities

- previously treated with irinotecan or similar drugs

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

response rate

Principal Investigator

Se Hoon Park, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gachon University Gil Medical Center, Incheon, Korea

Authority:

Korea: Food and Drug Administration

Study ID:

GMO-GI-71

NCT ID:

NCT00509964

Start Date:

May 2007

Completion Date:

July 2007

Related Keywords:

  • Stomach Neoplasm
  • Metastatic
  • Second-Line
  • Neoplasms
  • Stomach Neoplasms

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