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PegIntron vs IntronA in Adjuvant Treatment of Stage II Cutaneous Melanoma
NCT00221702Phase 3
Key facts
- Status
- Completed
- Start
- Jun 2003
- Primary completion
- Oct 2010
- Countries
- 1
- Sponsor
- Centre Hospitalier Universitaire de Bordeaux
- Modality
- Polymer-based Nanoparticles, Cytokines & Interferons
- Conditions
- cutaneous melanoma (CM)
01
Overview
Phase 3, randomised, open-label trial of peginterferon alfa-2b in cutaneous melanoma (CM) (2 arms), sponsored by Centre Hospitalier Universitaire de Bordeaux. Primary endpoint: Disease-Free Survival at 5 years. Started Jun 2003; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
PegIntron
PegIntron 100 mcg SC/week for 36 months
IntronA
IntronA 3miu TIWW SC for 18 months
03
Who it enrols
Patients with histologically proven cutaneous melanoma, tumor thickness >= 1.5 mm, no clinically detectable regional node metastasis or distant metastasis, and no prior systemic or radiation therapy.
04
Endpoints
Primary
Disease-Free Survival
Secondary
Time to Distant Metastasis
Overall Survival
Toxicity
Quality of Life
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