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| Sponsor: | European Organization for Research and Treatment of Cancer |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006249 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma (Skin) |
Biological: pegylated interferon alfa Procedure: adjuvant therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | PEG-Intron Observation After Regional Lymph Node Dissection in AJCC Stage III (TxN1-2MO) Melanoma Patients: a Randomized Phase III Trial |
| Study Start Date: | June 2000 |
OBJECTIVES:
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed previously resected stage III primary cutaneous melanoma or unknown primary with regional lymph node involvement
N1 disease
N2 disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
No severe cardiovascular disease including the following:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Hide Study Locations| Australia | |
| David Maddison Clincial Sciences | |
| Newcastle, Australia, NSW 2300 | |
| Australia, Victoria | |
| Austin and Repatriation Medical Centre | |
| Heidelberg West, Victoria, Australia, 3081 | |
| Peter MacCallum Cancer Institute | |
| East Melbourne, Victoria, Australia, 8006 | |
| Australia, Western Australia | |
| Royal Perth Hospital | |
| Perth, Western Australia, Australia, 6000 | |
| Sir Charles Gairdner Hospital, Perth | |
| Perth, Western Australia, Australia, 6009 | |
| Belgium | |
| Clinique Notre Dame de Grace | |
| Gosselies, Belgium, 6041 | |
| Cliniques Universitaires Saint-Luc | |
| Brussels, Belgium, 1200 | |
| Hopital Universitaire Erasme | |
| Brussels, Belgium, 1070 | |
| Institut Jules Bordet | |
| Brussels, Belgium, 1000 | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| Universitair Ziekenhuis Antwerpen | |
| Edegem, Belgium, B-2650 | |
| Bulgaria | |
| National Centre of Oncology | |
| Sofia, Bulgaria, 1756 | |
| Croatia | |
| University Hospital Sestre Milosrdnice | |
| Zagreb, Croatia, 10000 | |
| Czech Republic | |
| Charles University Hospital | |
| Prague (Praha), Czech Republic, 128 08 | |
| Estonia | |
| North-Estonian Regional Hospital Cancer Centre | |
| Tallinn, Estonia, 11619 | |
| France | |
| Centre Alexis Vautrin | |
| Vandoeuvre-les-Nancy, France, 54511 | |
| Centre Eugene Marquis | |
| Rennes, France, 35042 | |
| Centre Hospital Regional Universitaire de Limoges | |
| Limoges, France, 87042 | |
| Centre Hospitalier Regional et Universitaire de Lille | |
| Lille, France, 59037 | |
| Centre Hospitalier Regional et Universitaire de Saint-Etienne | |
| Saint Priest en Jarez, France, 42277 | |
| Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | |
| Montpellier, France, 34298 | |
| Centre Hospitalier Universitaire Bretonneau de Tours | |
| Tours, France, 37044 | |
| Centre Hospitalier Universitaire | |
| Reims, France, 51092 | |
| Centre Hospitalier Universitare d'Amens | |
| Amiens, France, 80054 | |
| Centre Leon Berard | |
| Lyon, France, 69373 | |
| Centre Hospitalier Regional Metz Thionville | |
| Thionville, France, 57126 | |
| Centre Rene Huguenin | |
| Saint Cloud, France, 92211 | |
| CHR de Besancon - Hopital Saint-Jacques | |
| Besancon, France, 25030 | |
| CHR de Grenoble - La Tronche | |
| Grenoble, France, 38043 | |
| CHU Ambroise Pare | |
| Boulogne Billancourt, France, F-92104 | |
| Hopital L'Archet - 2 | |
| Nice, France, F-06202 | |
| Hopital Haut Leveque | |
| Pessac, France, 33604 | |
| Hopital Bichat - Claude Bernard | |
| Paris, France, 75018 | |
| Hopital Saint Andre | |
| Bordeaux, France, 33075 | |
| Hopital Saint-Louis | |
| Paris, France, 75475 | |
| Hopital St. Eloi | |
| Montpellier, France, 34295 | |
| Hopitaux Universitaire de Strasbourg | |
| Strasbourg, France, 67091 | |
| Institut Gustave Roussy | |
| Villejuif, France, F-94805 | |
| Germany | |
| Georg August Universitaet | |
| Goettingen, Germany, D-37075 | |
| Haematologisch-Onkologische Praxis Altona | |
| Hamburg, Germany, D-22765 | |
| Klinikum der Stadt Mannheim | |
| Mannheim, Germany, D-68135 | |
| Otto - Von - Guericke - Universitaet Magdeburg | |
| Magdeburg, Germany, D-39120 | |
| Robert Roessle Klinik | |
| Berlin, Germany, D-13122 | |
| Universitaet Erlangen | |
| Erlangen, Germany, D-91054 | |
| Stadt. Kliniken | |
| Dortmund, Germany, 44123 | |
| Saint Josef Hospital | |
| Bochum 1, Germany, D-44791 | |
| Universitaet Leipzig - Chirurgische Klinik und Poliklinik I | |
| Leipzig, Germany, D-04103 | |
| Universitaet Wuerzburg/Hautkrankheiten | |
| Wuerzburg, Germany, D-97080 | |
| Universitaets-Hautklinik Heidelberg | |
| Heidelberg, Germany, D-69115 | |
| Israel | |
| Rambam Medical Center | |
| Haifa, Israel, 31096 | |
| Tel-Aviv Sourasky Medical Center | |
| Tel-Aviv, Israel, 64239 | |
| Wolfson Medical Center | |
| Holon, Israel, 58100 | |
| Italy | |
| Centro di Riferimento Oncologico - Aviano | |
| Aviano, Italy, 33081 | |
| European Institute of Oncology - Chemo Prevention | |
| Milano, Italy, 20141 | |
| Istituto Nazionale per la Ricerca sul Cancro | |
| Genoa (Genova), Italy, 16132 | |
| Istituto Nazionale per lo Studio e la Cura dei Tumori | |
| Naples, Italy, 80131 | |
| Ospendale S.M. Annunziata-A.S.DI Firenze | |
| Firenze, Italy, I-50011 | |
| Istituto Regina Elena | |
| Rome, Italy, 00161 | |
| Istituto Nazionale per lo Studio e la Cura dei Tumori | |
| Milano (Milan), Italy, 20133 | |
| Universita Degli Studi di Torino | |
| Torino, Italy, 10126 | |
| Netherlands | |
| Academisch Ziekenhuis Utrecht | |
| Utrecht, Netherlands, 3584 CX | |
| Erasmus University Medical Center | |
| Rotterdam, Netherlands, 3075 EA | |
| Leiden University Medical Center | |
| Leiden, Netherlands, 2300 CA | |
| University Medical Center Nijmegen | |
| Nijmegen, Netherlands, NL-6500 HB | |
| Vrije Universiteit Medisch Centrum | |
| Amsterdam, Netherlands, 1007 MB | |
| Poland | |
| Great Poland Cancer Center | |
| Poznan, Poland, 61 866 | |
| Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology | |
| Warsaw, Poland, 02-781 | |
| Portugal | |
| Instituto Portugues de Oncologia Centro do Porto, SA | |
| Porto, Portugal, 4200 | |
| Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa | |
| Lisbon, Portugal, 1099-023 Codex | |
| Slovenia | |
| Institute of Oncology, Ljubljana | |
| Ljubljana, Slovenia, Sl-1000 | |
| Spain | |
| Hospital Clinico Universitario | |
| Zaragoza, Spain, 50009 | |
| Hospital Universitario 12 de Octubre | |
| Madrid, Spain, 28041 | |
| Switzerland | |
| Inselspital, Bern | |
| Bern, Switzerland, CH-3010 | |
| Kantonspital Aarau | |
| Aarau, Switzerland, 5001 | |
| Ratisches Kantons und Regionalspital | |
| Chur, Switzerland, CH-7000 | |
| UniversitaetsSpital | |
| Zurich, Switzerland, CH-8091 | |
| Turkey | |
| Ege University Medical School | |
| Izmir, Turkey, 35220 | |
| Vakif Gureba Training Hospital | |
| Istanbul, Turkey, 34296 | |
| United Kingdom | |
| Churchill Hospital | |
| Oxford, United Kingdom, OX3 7LJ | |
| Selly Oak Hospital at University Hospital NHS Trust | |
| Birmingham, United Kingdom, B29 6JD | |
| United Kingdom, England | |
| Addenbrooke's NHS Trust | |
| Cambridge, England, United Kingdom, CB2 2QQ | |
| Bristol Haematology and Oncology Centre | |
| Bristol, England, United Kingdom, BS2 8ED | |
| Cheltenham General Hospital | |
| Cheltenham, England, United Kingdom, GL53 7AN | |
| Clatterbridge Centre for Oncology NHS Trust | |
| Merseyside, England, United Kingdom, CH63 4JY | |
| Guy's and St. Thomas' Hospitals NHS Trust | |
| London, England, United Kingdom, SE1 9RT | |
| Royal Marsden Hospital | |
| Sutton, England, United Kingdom, SM2 5PT | |
| Newcastle General Hospital | |
| Newcastle Upon Tyne, England, United Kingdom, NE4 6BE | |
| Princess Royal Hospital | |
| Hull, England, United Kingdom, HU8 9HE | |
| Royal Devon and Exeter Hospital | |
| Exeter, England, United Kingdom, EX2 5DW | |
| Royal Free Hospital | |
| London, England, United Kingdom, NW3 2QG | |
| Leicester Royal Infirmary | |
| Leicester, England, United Kingdom, LE1 5WW | |
| Royal Marsden NHS Trust | |
| London, England, United Kingdom, SW3 6JJ | |
| Royal Surrey County Hospital | |
| Guildford, England, United Kingdom, GU2 5XX | |
| Saint Bartholomew's Hospital | |
| London, England, United Kingdom, EC1A 7BE | |
| Salisbury District Hospital | |
| Salisbury, England, United Kingdom, SP2 8BJ | |
| St. George's Hospital | |
| London, England, United Kingdom, SW17 0QT | |
| Southend NHS Trust Hospital | |
| Westcliff-On-Sea, England, United Kingdom, SS0 0RY | |
| Southampton General Hospital | |
| Southampton, England, United Kingdom, SO16 6YD | |
| St. James's Hospital | |
| Leeds, England, United Kingdom, LS9 7TF | |
| Weston Park Hospital | |
| Sheffield, England, United Kingdom, S1O 2SJ | |
| United Kingdom, Northern Ireland | |
| Belfast City Hospital Trust | |
| Belfast, Northern Ireland, United Kingdom, BT9 7AB | |
| United Kingdom, Scotland | |
| Ninewells Hospital and Medical School | |
| Dundee, Scotland, United Kingdom, DD1 9SY | |
| Western Infirmary | |
| Glasgow, Scotland, United Kingdom, G11 6NT | |
| United Kingdom, Wales | |
| Velindre Cancer Center at Velinde Hospital | |
| Cardiff, Wales, United Kingdom, CF4 7XL | |
| Investigator: | Alexander M. M. Eggermont, MD, PhD | Daniel Den Hoed Cancer Center at Erasmus Medical Center |
More Information
| Study ID Numbers: | CDR0000068181, EORTC-18991 |
| Study First Received: | September 11, 2000 |
| Last Updated: | October 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00006249 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage III melanoma |
|
Interferon-alpha Anti-Infective Agents Neoplasms by Histologic Type Immunologic Factors Antineoplastic Agents Growth Substances Neoplasms, Nerve Tissue Interferons Physiological Effects of Drugs Angiogenesis Inhibitors Antiviral Agents |
Pharmacologic Actions Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Nevi and Melanomas Growth Inhibitors Angiogenesis Modulating Agents Interferon Alfa-2a |