NCT01502696

Adjuvant PEG Intron in Ulcerated Melanoma

Adjuvant Pegylated-Interferon-alpha2b (SylatronTM) for 2 Years Versus Observation in Patients With an Ulcerated Primary Cutaneous Melanoma With T(2-4)bN0M0: a Randomized Phase III Trial of the EORTC Melanoma Group.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,200 (estimated)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Patients with an ulcerated melanoma with Breslow \>1 mm, N0M0 have a significantly higher risk for relapse than patients with a non-ulcerated primary and about a 40-50% chance of developing stage IV disease to which they will almost invariably succumb. In stage I and II patients with an ulcerated primary who have been sentinel node (SN-staged) and found to be SN-negative there is still a 25-30% relapse risk. The purpose of this study is to evaluate the effectiveness and safety when treated with PEG IFN alfa-2b for 2 years as compared to observation (no treatment), administered after adequate surgery has been performed for ulcerated primary cutaneous melanomas.

Conditions

• Ulcerated Melanomas

Interventions

Type	Name	Description
BIOLOGICAL	PEG IFN alfa-2b	3µg/kg weekly injections

Timeline

• Start date: 2012-10-01
• Primary completion: 2019-04-01
• Completion: 2019-04-01
• First posted: 2012-01-02
• Last updated: 2019-03-04

Locations

58 sites across 12 countries: Austria, Belgium, Denmark, France, Germany, Italy, Netherlands, Poland, Portugal, Spain, Switzerland, United Kingdom