Spots Global Cancer Trial Database for Interferon Alfa Following Surgery in Treating Patients With Stage III Melanoma
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Trial Identification
Brief Title: Interferon Alfa Following Surgery in Treating Patients With Stage III Melanoma
Official Title: PEG-Intron Observation After Regional Lymph Node Dissection in AJCC Stage III (TxN1-2MO) Melanoma Patients: a Randomized Phase III Trial
Study ID: NCT00006249
Conditions
Study Description
Brief Summary: RATIONALE: Interferon alfa may interfere with the growth of the cancer cells. It is not yet known if this treatment is more effective than observation following surgery for stage III melanoma. PURPOSE: Randomized phase III trial to determine the effectiveness of interferon alfa in treating patients who have undergone surgery for stage III melanoma.
Detailed Description: OBJECTIVES: * Compare the effect of adjuvant therapy with pegylated interferon alfa vs observation, in terms of distant metastases-free survival, in patients with previously resected stage III melanoma. * Compare the overall survival in these patients after treatment with pegylated interferon alfa vs observation. * Determine the toxicity of pegylated interferon alfa in these patients. * Determine the compliance of these patients treated with pegylated interferon alfa. * Compare the quality of life in these patients after treatment with pegylated interferon alfa vs observation. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to type of nodal involvement (N1 vs N2), number of positive nodes (1 vs 2-4 vs 5 or more vs not assessed), Breslow primary (T1-2 vs T3 vs T4 vs unknown), ulceration of primary tumor (absent vs present vs unknown), sex, and center. Patients are randomized to one of two treatment arms. * Arm I: Patients receive pegylated interferon alfa subcutaneously weekly for 5 years. * Arm II: Patients undergo observation only. Treatment continues in the absence of distant metastases or unacceptable toxicity. Quality of life is assessed at baseline, and then at months 3, 12, 24, 36, 48, and 60. Patients are followed every 6 months for 5 years. PROJECTED ACCRUAL: A total of 1,200 patients (600 per treatment arm) will be accrued for this study within 1.5-2 years.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Peter MacCallum Cancer Institute, East Melbourne, Victoria, Australia
Austin and Repatriation Medical Centre, Heidelberg West, Victoria, Australia
Royal Perth Hospital, Perth, Western Australia, Australia
Sir Charles Gairdner Hospital, Perth, Perth, Western Australia, Australia
David Maddison Clincial Sciences, Newcastle, , Australia
Institut Jules Bordet, Brussels, , Belgium
Hopital Universitaire Erasme, Brussels, , Belgium
Cliniques Universitaires Saint-Luc, Brussels, , Belgium
Universitair Ziekenhuis Antwerpen, Edegem, , Belgium
Clinique Notre Dame de Grace, Gosselies, , Belgium
U.Z. Gasthuisberg, Leuven, , Belgium
National Centre of Oncology, Sofia, , Bulgaria
University Hospital Sestre Milosrdnice, Zagreb, , Croatia
Charles University Hospital, Prague (Praha), , Czech Republic
North-Estonian Regional Hospital Cancer Centre, Tallinn, , Estonia
Centre Hospitalier Universitare d'Amens, Amiens, , France
CHR de Besancon - Hopital Saint-Jacques, Besancon, , France
Hopital Saint Andre, Bordeaux, , France
CHU Ambroise Pare, Boulogne Billancourt, , France
CHR de Grenoble - La Tronche, Grenoble, , France
Centre Hospitalier Regional et Universitaire de Lille, Lille, , France
Centre Hospital Regional Universitaire de Limoges, Limoges, , France
Centre Leon Berard, Lyon, , France
Hopital St. Eloi, Montpellier, , France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle, Montpellier, , France
Hopital L'Archet - 2, Nice, , France
Hopital Bichat - Claude Bernard, Paris, , France
Hopital Saint-Louis, Paris, , France
Hopital Haut Leveque, Pessac, , France
Centre Hospitalier Universitaire, Reims, , France
Centre Eugene Marquis, Rennes, , France
Centre Rene Huguenin, Saint Cloud, , France
Centre Hospitalier Regional et Universitaire de Saint-Etienne, Saint Priest en Jarez, , France
Hopitaux Universitaire de Strasbourg, Strasbourg, , France
Centre Hospitalier Regional Metz Thionville, Thionville, , France
Centre Hospitalier Universitaire Bretonneau de Tours, Tours, , France
Centre Alexis Vautrin, Vandoeuvre-les-Nancy, , France
Institut Gustave Roussy, Villejuif, , France
Robert Roessle Klinik, Berlin, , Germany
Saint Josef Hospital, Bochum 1, , Germany
Stadt. Kliniken, Dortmund, , Germany
Universitaet Erlangen, Erlangen, , Germany
Georg August Universitaet, Goettingen, , Germany
Haematologisch-Onkologische Praxis Altona, Hamburg, , Germany
Universitaets-Hautklinik Heidelberg, Heidelberg, , Germany
Universitaet Leipzig - Chirurgische Klinik und Poliklinik I, Leipzig, , Germany
Otto - Von - Guericke - Universitaet Magdeburg, Magdeburg, , Germany
Klinikum der Stadt Mannheim, Mannheim, , Germany
Universitaet Wuerzburg/Hautkrankheiten, Wuerzburg, , Germany
Rambam Medical Center, Haifa, , Israel
Wolfson Medical Center, Holon, , Israel
Tel-Aviv Sourasky Medical Center, Tel-Aviv, , Israel
Centro di Riferimento Oncologico - Aviano, Aviano, , Italy
Ospendale S.M. Annunziata-A.S.DI Firenze, Firenze, , Italy
Istituto Nazionale per la Ricerca sul Cancro, Genoa (Genova), , Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori, Milano (Milan), , Italy
European Institute of Oncology - Chemo Prevention, Milano, , Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori, Naples, , Italy
Istituto Regina Elena, Rome, , Italy
Universita Degli Studi di Torino, Torino, , Italy
Vrije Universiteit Medisch Centrum, Amsterdam, , Netherlands
Leiden University Medical Center, Leiden, , Netherlands
University Medical Center Nijmegen, Nijmegen, , Netherlands
Erasmus University Medical Center, Rotterdam, , Netherlands
Academisch Ziekenhuis Utrecht, Utrecht, , Netherlands
Great Poland Cancer Center, Poznan, , Poland
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, , Poland
Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa, Lisbon, , Portugal
Instituto Portugues de Oncologia Centro do Porto, SA, Porto, , Portugal
Institute of Oncology, Ljubljana, Ljubljana, , Slovenia
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Clinico Universitario, Zaragoza, , Spain
Kantonspital Aarau, Aarau, , Switzerland
Inselspital, Bern, Bern, , Switzerland
Ratisches Kantons und Regionalspital, Chur, , Switzerland
UniversitaetsSpital, Zurich, , Switzerland
Vakif Gureba Training Hospital, Istanbul, , Turkey
Ege University Medical School, Izmir, , Turkey
Bristol Haematology and Oncology Centre, Bristol, England, United Kingdom
Addenbrooke's NHS Trust, Cambridge, England, United Kingdom
Cheltenham General Hospital, Cheltenham, England, United Kingdom
Royal Devon and Exeter Hospital, Exeter, England, United Kingdom
Royal Surrey County Hospital, Guildford, England, United Kingdom
Princess Royal Hospital, Hull, England, United Kingdom
St. James's Hospital, Leeds, England, United Kingdom
Leicester Royal Infirmary, Leicester, England, United Kingdom
Saint Bartholomew's Hospital, London, England, United Kingdom
Royal Free Hospital, London, England, United Kingdom
Guy's and St. Thomas' Hospitals NHS Trust, London, England, United Kingdom
St. George's Hospital, London, England, United Kingdom
Royal Marsden NHS Trust, London, England, United Kingdom
Clatterbridge Centre for Oncology NHS Trust, Merseyside, England, United Kingdom
Newcastle General Hospital, Newcastle Upon Tyne, England, United Kingdom
Salisbury District Hospital, Salisbury, England, United Kingdom
Weston Park Hospital, Sheffield, England, United Kingdom
Southampton General Hospital, Southampton, England, United Kingdom
Royal Marsden Hospital, Sutton, England, United Kingdom
Southend NHS Trust Hospital, Westcliff-On-Sea, England, United Kingdom
Belfast City Hospital Trust, Belfast, Northern Ireland, United Kingdom
Ninewells Hospital and Medical School, Dundee, Scotland, United Kingdom
Western Infirmary, Glasgow, Scotland, United Kingdom
Velindre Cancer Center at Velinde Hospital, Cardiff, Wales, United Kingdom
Selly Oak Hospital at University Hospital NHS Trust, Birmingham, , United Kingdom
Churchill Hospital, Oxford, , United Kingdom
Contact Details
Name: Alexander M. M. Eggermont, MD, PhD
Affiliation: Daniel Den Hoed Cancer Center at Erasmus Medical Center
Role: STUDY_CHAIR
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