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CPT-11 Monotherapy Versus S-1/CPT-11 Combination for S-1 Refractory Gastric Cancer
NCT00639327Phase 3
Key facts
- Status
- Completed
- Start
- Mar 2008
- Primary completion
- Apr 2011
- Countries
- 1
- Sponsor
- Japan Clinical Cancer Research Organization
- Modality
- Small Molecules
- Drugs
- tegafur
- Conditions
- gastric cancer (GC)
01
Overview
Phase 3, randomised, open-label trial of tegafur in gastric cancer (GC) (2 arms), sponsored by Japan Clinical Cancer Research Organization. Primary endpoints: Progressive Disease Rate at 6 weeks and Overall Survival at 2 years. Started Mar 2008; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
CPT-11 + S-1
S-1 + irinotecan combination therapy
CPT-11
Irinotecan monotherapy
03
Who it enrols
Patients with inoperable advanced or relapsed gastric adenocarcinoma who have progressed after first-line S-1 based chemotherapy (excluding S-1 + CPT-11), with ECOG PS <= 1, adequate organ function, and life expectancy > 12 weeks.
04
Endpoints
Primary
Progressive Disease Rate
Overall Survival
Secondary
Adverse Events
Response Rates
Progression Free Survival
Time to Treatment Failure
Change over rates to 3rd line
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