Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Gemcitabine plus UFTE in refractory metastatic colorectal cancer
NCT01409005Phase 2
Key facts
- Status
- Completed
- Start
- Jun 2011
- Primary completion
- Feb 2013
- Countries
- 1
- Sponsor
- Seoul National University Bundang Hospital
- Modality
- Small Molecules
- Conditions
- colorectal cancer (CRC)
01
Overview
Phase 2, open-label, single-arm trial of gemcitabine and tegafur + uracil in colorectal cancer (CRC), sponsored by Seoul National University Bundang Hospital. Primary endpoint: 8-weeks progression free survival rate. Started Jun 2011; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Gemcitabine plus UFTE
Gemcitabine and UFTE chemotherapy
03
Who it enrols
Patients with metastatic or recurrent colorectal cancer refractory to fluoropyrimidine, oxaliplatin, and irinotecan. Must have measurable disease and adequate organ function. Excludes patients with prior UFTE therapy (unless adjuvant > 6 months disease-free), bowel obstruction, or severe comorbidities.
04
Endpoints
Primary
8-weeks progression free survival rate
Secondary
Overall Survival
Response Rate
Percentage of Patients with Adverse Events
Beyond the preview
Go deeper on NCT01409005.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT01409005.