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Interferon Alfa Following Surgery in Treating Patients With Stage III Melanoma

9. februar 2015 opdateret af: European Organisation for Research and Treatment of Cancer - EORTC

PEG-Intron Observation After Regional Lymph Node Dissection in AJCC Stage III (TxN1-2MO) Melanoma Patients: a Randomized Phase III Trial

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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1258

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Australien
      • Newcastle, Australien, NSW 2300
        • David Maddison Clincial Sciences
    • Victoria
      • East Melbourne, Victoria, Australien, 8006
        • Peter Maccallum Cancer Institute
      • Heidelberg West, Victoria, Australien, 3081
        • Austin and Repatriation Medical Centre
    • Western Australia
      • Perth, Western Australia, Australien, 6000
        • Royal Perth Hospital
      • Perth, Western Australia, Australien, 6009
        • Sir Charles Gairdner Hospital, Perth
  • Belgien
      • Brussels, Belgien, 1200
        • Cliniques Universitaires Saint-Luc
      • Brussels, Belgien, 1000
        • Institut Jules Bordet
      • Brussels, Belgien, 1070
        • Hopital Universitaire Erasme
      • Edegem, Belgien, B-2650
        • Universitair Ziekenhuis Antwerpen
      • Gosselies, Belgien, 6041
        • Clinique Notre Dame de Grâce
      • Leuven, Belgien, B-3000
        • U.Z. Gasthuisberg
  • Bulgarien
      • Sofia, Bulgarien, 1756
        • National Centre of Oncology
  • Det Forenede Kongerige
      • Birmingham, Det Forenede Kongerige, B29 6JD
        • Selly Oak Hospital at University Hospital NHS Trust
      • Oxford, Det Forenede Kongerige, OX3 7LJ
        • Churchill Hospital
    • England
      • Bristol, England, Det Forenede Kongerige, BS2 8ED
        • Bristol Haematology and Oncology Centre
      • Cambridge, England, Det Forenede Kongerige, CB2 2QQ
        • Addenbrooke's NHS Trust
      • Cheltenham, England, Det Forenede Kongerige, GL53 7AN
        • Cheltenham General Hospital
      • Exeter, England, Det Forenede Kongerige, EX2 5DW
        • Royal Devon and Exeter Hospital
      • Guildford, England, Det Forenede Kongerige, GU2 5XX
        • Royal Surrey County Hospital
      • Hull, England, Det Forenede Kongerige, HU8 9HE
        • Princess Royal Hospital
      • Leeds, England, Det Forenede Kongerige, LS9 7TF
        • St. James's Hospital
      • Leicester, England, Det Forenede Kongerige, LE1 5WW
        • Leicester Royal Infirmary
      • London, England, Det Forenede Kongerige, SW3 6JJ
        • Royal Marsden NHS Trust
      • London, England, Det Forenede Kongerige, NW3 2QG
        • Royal Free Hospital
      • London, England, Det Forenede Kongerige, SW17 0QT
        • St. George's Hospital
      • London, England, Det Forenede Kongerige, EC1A 7BE
        • Saint Bartholomew's Hospital
      • London, England, Det Forenede Kongerige, SE1 9RT
        • Guy's and St. Thomas' Hospitals NHS Trust
      • Merseyside, England, Det Forenede Kongerige, CH63 4JY
        • Clatterbridge Centre for Oncology NHS Trust
      • Newcastle Upon Tyne, England, Det Forenede Kongerige, NE4 6BE
        • Newcastle General Hospital
      • Salisbury, England, Det Forenede Kongerige, SP2 8BJ
        • Salisbury District Hospital
      • Sheffield, England, Det Forenede Kongerige, S1O 2SJ
        • Weston Park Hospital
      • Southampton, England, Det Forenede Kongerige, SO16 6YD
        • Southampton General Hospital
      • Sutton, England, Det Forenede Kongerige, SM2 5PT
        • Royal Marsden Hospital
      • Westcliff-On-Sea, England, Det Forenede Kongerige, SS0 0RY
        • Southend NHS Trust Hospital
    • Northern Ireland
      • Belfast, Northern Ireland, Det Forenede Kongerige, BT9 7AB
        • Belfast City Hospital Trust
    • Scotland
      • Dundee, Scotland, Det Forenede Kongerige, DD1 9SY
        • Ninewells Hospital and Medical School
      • Glasgow, Scotland, Det Forenede Kongerige, G11 6NT
        • Western Infirmary
    • Wales
      • Cardiff, Wales, Det Forenede Kongerige, CF4 7XL
        • Velindre Cancer Center at Velinde Hospital
  • Estland
      • Tallinn, Estland, 11619
        • North-Estonian Regional Hospital Cancer Centre
  • Frankrig
      • Amiens, Frankrig, 80054
        • Centre Hospitalier Universitare d'Amens
      • Besancon, Frankrig, 25030
        • CHR de Besancon - Hopital Saint-Jacques
      • Bordeaux, Frankrig, 33075
        • Hôpital Saint André
      • Boulogne Billancourt, Frankrig, F-92104
        • CHU Ambroise Pare
      • Grenoble, Frankrig, 38043
        • Chr De Grenoble - La Tronche
      • Lille, Frankrig, 59037
        • Centre Hospitalier Regional et Universitaire de Lille
      • Limoges, Frankrig, 87042
        • Centre Hospital Regional Universitaire de Limoges
      • Lyon, Frankrig, 69373
        • Centre Leon Berard
      • Montpellier, Frankrig, 34298
        • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
      • Montpellier, Frankrig, 34295
        • Hopital St. Eloi
      • Nice, Frankrig, F-06202
        • Hopital L'Archet - 2
      • Paris, Frankrig, 75018
        • Hôpital Bichat - Claude Bernard
      • Paris, Frankrig, 75475
        • Hôpital Saint-Louis
      • Pessac, Frankrig, 33604
        • Hôpital Haut Levêque
      • Reims, Frankrig, 51092
        • Centre Hospitalier Universitaire
      • Rennes, Frankrig, 35042
        • Centre Eugene Marquis
      • Saint Cloud, Frankrig, 92211
        • Centre Rene Huguenin
      • Saint Priest en Jarez, Frankrig, 42277
        • Centre Hospitalier Regional et Universitaire de Saint-Etienne
      • Strasbourg, Frankrig, 67091
        • Hopitaux Universitaire de Strasbourg
      • Thionville, Frankrig, 57126
        • Centre Hospitalier Regional Metz Thionville
      • Tours, Frankrig, 37044
        • Centre Hospitalier Universitaire Bretonneau de Tours
      • Vandoeuvre-les-Nancy, Frankrig, 54511
        • Centre Alexis Vautrin
      • Villejuif, Frankrig, F-94805
        • Institut Gustave Roussy
  • Holland
      • Amsterdam, Holland, 1007 MB
        • Vrije Universiteit Medisch Centrum
      • Leiden, Holland, 2300 CA
        • Leiden University Medical Center
      • Nijmegen, Holland, NL-6500 HB
        • University Medical Center Nijmegen
      • Rotterdam, Holland, 3075 EA
        • Erasmus University Medical Center
      • Utrecht, Holland, 3584 CX
        • Academisch Ziekenhuis Utrecht
  • Israel
      • Haifa, Israel, 31096
        • Rambam Medical Center
      • Holon, Israel, 58100
        • Wolfson Medical Center
      • Tel-Aviv, Israel, 64239
        • Tel-Aviv Sourasky Medical Center
  • Italien
      • Aviano, Italien, 33081
        • Centro di Riferimento Oncologico - Aviano
      • Firenze, Italien, I-50011
        • Ospendale S.M. Annunziata-A.S.DI Firenze
      • Genoa (Genova), Italien, 16132
        • Istituto Nazionale per la Ricerca sul Cancro
      • Milano, Italien, 20141
        • European Institute of Oncology - Chemo Prevention
      • Milano (Milan), Italien, 20133
        • Istituto Nazionale per lo Studio e la Cura dei Tumori
      • Naples, Italien, 80131
        • Istituto Nazionale per lo Studio e la Cura dei Tumori
      • Rome, Italien, 00161
        • Istituto Regina Elena
      • Torino, Italien, 10126
        • Universita Degli Studi di Torino
  • Kalkun
      • Istanbul, Kalkun, 34296
        • Vakif Gureba Training Hospital
      • Izmir, Kalkun, 35220
        • Ege University Medical School
  • Kroatien
      • Zagreb, Kroatien, 10000
        • University Hospital Sestre Milosrdnice
  • Polen
      • Poznan, Polen, 61 866
        • Great Poland Cancer Center
      • Warsaw, Polen, 02-781
        • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
  • Portugal
      • Lisbon, Portugal, 1099-023 Codex
        • Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa
      • Porto, Portugal, 4200
        • Instituto Portugues de Oncologia Centro do Porto, SA
  • Schweiz
      • Aarau, Schweiz, 5001
        • Kantonspital Aarau
      • Bern, Schweiz, CH-3010
        • Inselspital, Bern
      • Chur, Schweiz, CH-7000
        • Ratisches Kantons und Regionalspital
      • Zurich, Schweiz, CH-8091
        • UniversitaetsSpital
  • Slovenien
      • Ljubljana, Slovenien, Sl-1000
        • Institute of Oncology, Ljubljana
  • Spanien
      • Madrid, Spanien, 28041
        • Hospital Universitario 12 de Octubre
      • Zaragoza, Spanien, 50009
        • Hospital Clínico Universitario
  • Tjekkiet
      • Prague (Praha), Tjekkiet, 128 08
        • Charles University Hospital
  • Tyskland
      • Berlin, Tyskland, D-13122
        • Robert Roessle Klinik
      • Bochum 1, Tyskland, D-44791
        • Saint Josef Hospital
      • Dortmund, Tyskland, 44123
        • Stadt. Kliniken
      • Erlangen, Tyskland, D-91054
        • Universitaet Erlangen
      • Goettingen, Tyskland, D-37075
        • Georg August Universitaet
      • Hamburg, Tyskland, D-22765
        • Haematologisch-Onkologische Praxis Altona
      • Heidelberg, Tyskland, D-69115
        • Universitaets-Hautklinik Heidelberg
      • Leipzig, Tyskland, D-04103
        • Universitaet Leipzig - Chirurgische Klinik und Poliklinik I
      • Magdeburg, Tyskland, D-39120
        • Otto - Von - Guericke - Universitaet Magdeburg
      • Mannheim, Tyskland, D-68135
        • Klinikum der Stadt Mannheim
      • Wuerzburg, Tyskland, D-97080
        • Universitaet Wuerzburg/Hautkrankheiten

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: observation
5 years observation + 5 years follow up
Eksperimentel: pegylated interferon alfa
5 years pegylated interferon alfa + 5 years follow up
Procedure: adjuverende terapi
Biologisk: pegyleret interferon alfa

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
distant-metastasis free-survival (DMFS)
Tidsramme: from randomization
distant-metastasis free-survival (DMFS) after randomization
from randomization

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
survival
Tidsramme: from randomization till death
duration of survival: time from randomization until death, whatever the cause
from randomization till death
toxicity
Tidsramme: from randomization
toxicity
from randomization

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
quality of life
Tidsramme: from randomization
Quality of life evaluation
from randomization

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Efterforskere

  • Studiestol: Alexander M. M. Eggermont, MD, PhD, Daniel Den Hoed Cancer Center at Erasmus Medical Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2000

Primær færdiggørelse (Faktiske)

1. august 2003

Datoer for studieregistrering

Først indsendt

11. september 2000

Først indsendt, der opfyldte QC-kriterier

26. januar 2003

Først opslået (Skøn)

27. januar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

10. februar 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. februar 2015

Sidst verificeret

1. februar 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • EORTC-18991

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Melanom (hud)

Kliniske forsøg med adjuverende terapi

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in China

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner