Irinotecan Versus Only Best Supportive Care for Gastric Cancer

Sponsor
Charite University, Berlin, Germany
Study ID
NCT00144378
Phase
PHASE3
Status
Completed

Conditions

  • Neoplasm Metastasis
  • Stomach Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The median survival at progression after first-line chemotherapy for metastatic gastric cancer is about 2.5 months. There are no data which a possible benefit of second line therapy. for this reason a trial which investigates a possible benefit or chemotherapy compared to best supportive care as second line treatment is urgently necessary. Irinotecan shows response rates of 20% in the first line therapy with high rates od disease stabilization. There are few trials investigating irinotecan in the second line setting. Response rates of 20% are reported in tis setting. Irinotecan is supplied without costs from the company Pfizer.

Key Dates

Start date
Oct 31, 2002
Status verified
Apr 2007

Study Design

Enrollment
44 participants
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP

Primary Outcome Measure

median survival

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