Interferon Alfa Following Surgery in Treating Patients With Stage III Melanoma
- Conditions
- Melanoma (Skin)
- Interventions
- Biological: pegylated interferon alfaProcedure: adjuvant therapy
- Registration Number
- NCT00006249
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1258
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description pegylated interferon alfa pegylated interferon alfa 5 years pegylated interferon alfa + 5 years follow up pegylated interferon alfa adjuvant therapy 5 years pegylated interferon alfa + 5 years follow up
- Primary Outcome Measures
Name Time Method distant-metastasis free-survival (DMFS) from randomization distant-metastasis free-survival (DMFS) after randomization
- Secondary Outcome Measures
Name Time Method toxicity from randomization toxicity
survival from randomization till death duration of survival: time from randomization until death, whatever the cause
Trial Locations
- Locations (103)
Vrije Universiteit Medisch Centrum
🇳🇱Amsterdam, Netherlands
Leiden University Medical Center
🇳🇱Leiden, Netherlands
David Maddison Clincial Sciences
🇦🇺Newcastle, Australia
Institut Jules Bordet
🇧🇪Brussels, Belgium
Hopital Universitaire Erasme
🇧🇪Brussels, Belgium
National Centre of Oncology
🇧🇬Sofia, Bulgaria
University Hospital Sestre Milosrdnice
ðŸ‡ðŸ‡·Zagreb, Croatia
CHR de Besancon - Hopital Saint-Jacques
🇫🇷Besancon, France
Centre Hospitalier Universitare d'Amens
🇫🇷Amiens, France
CHU Ambroise Pare
🇫🇷Boulogne Billancourt, France
Hopital Saint Andre
🇫🇷Bordeaux, 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 L'Archet - 2
🇫🇷Nice, France
Hopital St. Eloi
🇫🇷Montpellier, France
Hopital Saint-Louis
🇫🇷Paris, France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
🇫🇷Montpellier, France
Hopital Bichat - Claude Bernard
🇫🇷Paris, France
Hopital Haut Leveque
🇫🇷Pessac, France
Centre Rene Huguenin
🇫🇷Saint Cloud, France
Centre Alexis Vautrin
🇫🇷Vandoeuvre-les-Nancy, France
Centre Hospitalier Universitaire
🇫🇷Reims, France
Centre Eugene Marquis
🇫🇷Rennes, France
Centre Hospitalier Regional Metz Thionville
🇫🇷Thionville, France
Centre Hospitalier Universitaire Bretonneau de Tours
🇫🇷Tours, France
Centre Hospitalier Regional et Universitaire de Saint-Etienne
🇫🇷Saint Priest en Jarez, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Hopitaux Universitaire de Strasbourg
🇫🇷Strasbourg, France
Saint Josef Hospital
🇩🇪Bochum 1, Germany
Georg August Universitaet
🇩🇪Goettingen, Germany
Universitaet Erlangen
🇩🇪Erlangen, Germany
Stadt. Kliniken
🇩🇪Dortmund, Germany
Robert Roessle Klinik
🇩🇪Berlin, 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
Ospendale S.M. Annunziata-A.S.DI Firenze
🇮🇹Firenze, Italy
Istituto Nazionale per la Ricerca sul Cancro
🇮🇹Genoa (Genova), Italy
Centro di Riferimento Oncologico - Aviano
🇮🇹Aviano, Italy
Universita Degli Studi di Torino
🇮🇹Torino, Italy
European Institute of Oncology - Chemo Prevention
🇮🇹Milano, Italy
Istituto Regina Elena
🇮🇹Rome, Italy
University Medical Center Nijmegen
🇳🇱Nijmegen, Netherlands
Erasmus University Medical Center
🇳🇱Rotterdam, Netherlands
Academisch Ziekenhuis Utrecht
🇳🇱Utrecht, Netherlands
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Clinico Universitario
🇪🇸Zaragoza, Spain
Inselspital, Bern
🇨ðŸ‡Bern, Switzerland
Vakif Gureba Training Hospital
🇹🇷Istanbul, Turkey
Ege University Medical School
🇹🇷Izmir, Turkey
Cheltenham General Hospital
🇬🇧Cheltenham, England, United Kingdom
Royal Free Hospital
🇬🇧London, England, United Kingdom
Guy's and St. Thomas' Hospitals NHS Trust
🇬🇧London, England, United Kingdom
Weston Park Hospital
🇬🇧Sheffield, England, United Kingdom
Ninewells Hospital and Medical School
🇬🇧Dundee, Scotland, United Kingdom
Western Infirmary
🇬🇧Glasgow, Scotland, United Kingdom
Selly Oak Hospital at University Hospital NHS Trust
🇬🇧Birmingham, United Kingdom
Velindre Cancer Center at Velinde Hospital
🇬🇧Cardiff, Wales, United Kingdom
Churchill Hospital
🇬🇧Oxford, United Kingdom
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
Sir Charles Gairdner Hospital, Perth
🇦🇺Perth, Western Australia, Australia
St. James's Hospital
🇬🇧Leeds, England, United Kingdom
Saint Bartholomew's Hospital
🇬🇧London, England, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, England, United Kingdom
Belfast City Hospital Trust
🇬🇧Belfast, Northern Ireland, United Kingdom
Istituto Nazionale per lo Studio e la Cura dei Tumori
🇮🇹Naples, Italy
Institute of Oncology, Ljubljana
🇸🇮Ljubljana, Slovenia
Kantonspital Aarau
🇨ðŸ‡Aarau, Switzerland
Great Poland Cancer Center
🇵🇱Poznan, Poland
Instituto Portugues de Oncologia Centro do Porto, SA
🇵🇹Porto, Portugal
Clatterbridge Centre for Oncology NHS Trust
🇬🇧Merseyside, England, United Kingdom
Peter MacCallum Cancer Institute
🇦🇺East Melbourne, Victoria, Australia
Addenbrooke's NHS Trust
🇬🇧Cambridge, England, United Kingdom
Ratisches Kantons und Regionalspital
🇨ðŸ‡Chur, Switzerland
North-Estonian Regional Hospital Cancer Centre
🇪🇪Tallinn, Estonia
Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa
🇵🇹Lisbon, Portugal
St. George's Hospital
🇬🇧London, England, United Kingdom
Royal Marsden NHS Trust
🇬🇧London, England, United Kingdom
Newcastle General Hospital
🇬🇧Newcastle Upon Tyne, England, United Kingdom
Salisbury District Hospital
🇬🇧Salisbury, England, United Kingdom
Royal Marsden Hospital
🇬🇧Sutton, England, United Kingdom
Clinique Notre Dame de Grace
🇧🇪Gosselies, Belgium
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
🇵🇱Warsaw, Poland
Austin and Repatriation Medical Centre
🇦🇺Heidelberg West, Victoria, Australia
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Charles University Hospital
🇨🇿Prague (Praha), Czech Republic
UniversitaetsSpital
🇨ðŸ‡Zurich, Switzerland
Princess Royal Hospital
🇬🇧Hull, England, United Kingdom
Bristol Haematology and Oncology Centre
🇬🇧Bristol, England, United Kingdom
Royal Surrey County Hospital
🇬🇧Guildford, England, United Kingdom
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
Royal Devon and Exeter Hospital
🇬🇧Exeter, England, United Kingdom
Southampton General Hospital
🇬🇧Southampton, England, United Kingdom
Southend NHS Trust Hospital
🇬🇧Westcliff-On-Sea, England, United Kingdom