EORTC protocol 18081

Adjuvant peginterferon alpha-2b for 2 years vs Observation in patients with an ulcerated primary cutaneous melanoma with T(2-4)bN0M0: a randomized phase III trial of the EORTC Melanoma Group
Trial StatusRecruiting
DatesDate of activation: 23-Oct-12
Data management at EORTCFull
Phase3
Randomized trialYes
TypeAdjuvant
Targeted Sample sizeEORTC Groups: 1200 - All Groups: 1200
Number of steps3
DrugPeginterferon alfa-2b
Study StaffAlessandro Testori (Study Coordinator) - Istituto Europeo Di Oncologia, Milano
Stefan Suciu (Statistician) - EORTC Headquarters, Brussels
Sven Janssen (Data Manager) - EORTC Headquarters, Brussels
Ravi Karra (Coordinating Physician) - EORTC Headquarters, Brussels
Gaetan de Schaetzen (Project Manager) - EORTC Headquarters, Brussels, gaetan.deschaetzen( at )eortc.be, +32 27741618
Type of cancerMelanoma
Participating GroupsEORTC Melanoma Group(Coordinating Group)
NCIC Clinical Trial Group
Centers authorized by EORTC Medical University of Graz (Graz, Austria) - Inst. 908
Hôpitaux Universitaires Bordet-Erasme - Institut Jules Bordet (Brussels, Belgium) - Inst. 101
Universitair Ziekenhuis Gent (Gent, Belgium) - Inst. 104
U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium) - Inst. 147
Odense University Hospital (Odense, Denmark) - Inst. 411
Assistance Publique - Hôpitaux de Paris - Hopital Bichat-Claude Bernard AP-HP (Paris, France) - Inst. 191
Assistance Publique - Hôpitaux de Paris - Hopital Saint-Louis AP-HP (Paris, France) - Inst. 192
CHRU de Besancon - Hopital Saint-Jacques (Besancon, France) - Inst. 204
CHU de Grenoble - La Tronche - Hôpital A. Michallon (Grenoble, France) - Inst. 215
Institut Gustave Roussy (Villejuif, France) - Inst. 225
Centre Leon Berard (Lyon, France) - Inst. 227
CHU d'Amiens - CHU Amiens - Hopital Sud (Salouel, France) - Inst. 2321
CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre (Bordeaux, France) - Inst. 236
CHRU de Lille (Lille, France) - Inst. 254
Assistance Publique - Hôpitaux de Marseille - Hôpital de La Timone (Marseille, France) - Inst. 287
CHU de Bordeaux - Group Hospitalier Sud - Hopital Haut-Lévêque (Pessac, France) - Inst. 433
CHU de Nice - Hopital De L'Archet (Nice, France) - Inst. 2292
CHU Ambroise Pare AP-HP (Boulogne-Billancourt, France) - Inst. 2303
Protocol summaryCancer.gov (PDQ)
ClinicalTrials.gov
NCT numberNCT01502696
EudraCT2009-010273-20
Protocol documents in PDF
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Study documentation
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