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Adjuvant IL-2, IFN-alpha, and 5-FU in Renal Cell Carcinoma
NCT00053807Phase 3
Key facts
- Status
- Completed
- Start
- Feb 1998
- Primary completion
- Jan 2004
- Countries
- 8
- Sponsor
- European Organisation for Research and Treatment of Cancer
- Modality
- Cytokines & Interferons, Small Molecules
- Conditions
- renal cell carcinoma (RCC)
01
Overview
Phase 3, randomised, open-label trial of aldesleukin, interferon alfa and fluorouracil in renal cell carcinoma (RCC) (2 arms), sponsored by European Organisation for Research and Treatment of Cancer. Primary endpoints: Disease-Free Survival and Overall Survival. Started Feb 1998; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Combination Therapy
Aldesleukin + Interferon alfa + Fluorouracil
Observation
Observation only
03
Who it enrols
Patients with histologically confirmed primary renal cell carcinoma at high risk of relapse (T3b-T4, or N1-N2, or positive margins/vascular invasion) who have undergone radical surgery within the past month.
04
Endpoints
Primary
Disease-Free Survival
Overall Survival
Secondary
Quality of Life
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