Interferon Alfa Following Surgery in Treating Patients With Stage III Melanoma
NCT ID: NCT00006249
Last Updated: 2015-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
1258 participants
INTERVENTIONAL
2000-06-30
Brief Summary
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PURPOSE: Randomized phase III trial to determine the effectiveness of interferon alfa in treating patients who have undergone surgery for stage III melanoma.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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observation
5 years observation + 5 years follow up
No interventions assigned to this group
pegylated interferon alfa
5 years pegylated interferon alfa + 5 years follow up
pegylated interferon alfa
adjuvant therapy
Interventions
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pegylated interferon alfa
adjuvant therapy
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed previously resected stage III primary cutaneous melanoma or unknown primary with regional lymph node involvement
* N1 disease
* Microscopic, nonpalpable nodal involvement
* Primary melanoma of any stage with clinically inapparent N1 regional lymph node metastases (T1-4, N1, M0) detected by elective lymph node dissection or sentinel node biopsy
* N2 disease
* Palpable nodal involvement with synchronous primary melanoma or apparent nodal disease after prior excision (any pT, N2, M0)
* Regional lymph node recurrence at any interval after surgery for primary melanoma of any depth (T1-4, rN2, M0)
* Complete resection of primary melanoma with adequate surgical margins
* Full lymphadenectomy must be performed within 70 days of study
* No mucous membrane melanoma or ocular melanoma
* No evidence of distant or nonregional lymph node metastases or in transit metastases (even if previously resected)
* No incompletely resected disease due to gross extracapsular extension
PATIENT CHARACTERISTICS:
Age:
* 18 to 70
Performance status:
* ECOG 0-1
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 3,000/mm\^3
* Platelet count greater than 100,000/mm\^3
* Hemoglobin at least 9 g/dL
Hepatic:
* SGOT and SGPT less than 2 times upper limit of normal
* No active hepatitis
Renal:
* Creatinine less than 2.0 mg/dL
Cardiovascular:
* No severe cardiovascular disease including the following:
* Arrhythmias requiring chronic treatment
* Congestive heart failure (New York Heart Association class III or IV)
* Symptomatic ischemic heart disease
Other:
* No other prior malignancy within the past 5 years except surgically cured nonmelanomatous skin cancer or carcinoma in situ of the cervix
* No thyroid dysfunction unresponsive to therapy
* No uncontrolled diabetes mellitus
* No active autoimmune disease
* No active and/or uncontrolled infection
* No history of neuropsychiatric disorder requiring hospitalization
* No known active alcohol or drug abuse
* HIV negative
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior interferon alfa
* No prior immunotherapy for melanoma
* No other concurrent immunologic or biologic therapy
* No concurrent colony stimulating factors including epoetin alfa and filgrastim (G-CSF)
Chemotherapy:
* No prior chemotherapy for melanoma
* No concurrent chemotherapy
Endocrine therapy:
* No prior hormonal therapy for melanoma
* No concurrent hormonal therapy
* No concurrent chronic systemic corticosteroid therapy
Radiotherapy:
* No prior radiotherapy for melanoma
* No concurrent radiotherapy
Surgery:
* See Disease Characteristics
* Recovered from any prior recent surgery
Other:
* At least 30 days since other prior experimental therapy
* No other concurrent investigational drugs
18 Years
70 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Alexander M. M. Eggermont, MD, PhD
Role: STUDY_CHAIR
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Locations
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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), , Czechia
North-Estonian Regional Hospital Cancer Centre
Tallinn, , Estonia
Centre Hospitalier Universitare d'Amens
Amiens, , France
CHR de Besancon - Hopital Saint-Jacques
Besançon, , 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
Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy
Villejuif, , France
Robert Roessle Klinik
Berlin, , Germany
Saint Josef Hospital
Bochum, , Germany
Stadt. Kliniken
Dortmund, , Germany
Universitaet Erlangen
Erlangen, , Germany
Georg August Universitaet
Göttingen, , 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
Würzburg, , 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
Florence, , Italy
Istituto Nazionale per la Ricerca sul Cancro
Genoa (Genova), , Italy
European Institute of Oncology - Chemo Prevention
Milan, , Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori
Milano (Milan), , 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 (Türkiye)
Ege University Medical School
Izmir, , Turkey (Türkiye)
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
Countries
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References
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Eggermont AM, Suciu S, Testori A, Kruit WH, Marsden J, Punt CJ, Santinami M, Sales F, Schadendorf D, Patel P, Dummer R, Robert C, Keilholz U, Yver A, Spatz A. Ulceration and stage are predictive of interferon efficacy in melanoma: results of the phase III adjuvant trials EORTC 18952 and EORTC 18991. Eur J Cancer. 2012 Jan;48(2):218-25. doi: 10.1016/j.ejca.2011.09.028. Epub 2011 Nov 5.
Eggermont AM, Suciu S, Santinami M, et al.: EORTC 18991 phase III trial: Long-term adjuvant pegylated interferon-α2b (PEG-IFN) versus observation in resected stage III melanoma: long-term results at 7.6-years follow-up. [Abstract] J Clin Oncol 29 (Suppl 15): A-8506b, 2011.
Bouwhuis MG, Suciu S, Testori A, Kruit WH, Sales F, Patel P, Punt CJ, Santinami M, Spatz A, Ten Hagen TL, Eggermont AM. Phase III trial comparing adjuvant treatment with pegylated interferon Alfa-2b versus observation: prognostic significance of autoantibodies--EORTC 18991. J Clin Oncol. 2010 May 10;28(14):2460-6. doi: 10.1200/JCO.2009.24.6264. Epub 2010 Apr 12.
Eggermont AM, Bouwhuis MG, Kruit WH, Testori A, ten Hagen T, Yver A, Xu C. Serum concentrations of pegylated interferon alpha-2b in patients with resected stage III melanoma receiving adjuvant pegylated interferon alpha-2b in a randomized phase III trial (EORTC 18991). Cancer Chemother Pharmacol. 2010 Mar;65(4):671-7. doi: 10.1007/s00280-009-1072-z. Epub 2009 Jul 21.
Bottomley A, Coens C, Suciu S, Santinami M, Kruit W, Testori A, Marsden J, Punt C, Sales F, Gore M, Mackie R, Kusic Z, Dummer R, Patel P, Schadendorf D, Spatz A, Keilholz U, Eggermont A. Adjuvant therapy with pegylated interferon alfa-2b versus observation in resected stage III melanoma: a phase III randomized controlled trial of health-related quality of life and symptoms by the European Organisation for Research and Treatment of Cancer Melanoma Group. J Clin Oncol. 2009 Jun 20;27(18):2916-23. doi: 10.1200/JCO.2008.20.2069. Epub 2009 May 11.
Fusi A, Collette S, Busse A, Suciu S, Rietz A, Santinami M, Kruit WH, Testori A, Punt CJ, Dalgleish AG, Spatz A, Eggermont AM, Keilholz U. Circulating melanoma cells and distant metastasis-free survival in stage III melanoma patients with or without adjuvant interferon treatment (EORTC 18991 side study). Eur J Cancer. 2009 Dec;45(18):3189-97. doi: 10.1016/j.ejca.2009.09.004. Epub 2009 Sep 28.
Eggermont AM, Suciu S, Santinami M, Testori A, Kruit WH, Marsden J, Punt CJ, Sales F, Gore M, MacKie R, Kusic Z, Dummer R, Hauschild A, Musat E, Spatz A, Keilholz U; EORTC Melanoma Group. Adjuvant therapy with pegylated interferon alfa-2b versus observation alone in resected stage III melanoma: final results of EORTC 18991, a randomised phase III trial. Lancet. 2008 Jul 12;372(9633):117-126. doi: 10.1016/S0140-6736(08)61033-8.
Eggermont AM, Suciu S, Santinami M, et al.: EORTC 18991: long-term adjuvant pegylated interferon-alpha2b (PEG-IFN) compared to observation in resected stage III melanoma, final results of a randomized phase III trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-8504, 473s, 2007.
Other Identifiers
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EORTC-18991
Identifier Type: -
Identifier Source: secondary_id
EORTC-18991
Identifier Type: -
Identifier Source: org_study_id
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