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Interferon Alfa Following Surgery in Treating Patients With Stage III Melanoma

Primary Purpose

Melanoma (Skin)

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
pegylated interferon alfa
adjuvant therapy
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage III melanoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peter MacCallum Cancer Institute
  • Austin and Repatriation Medical Centre
  • Royal Perth Hospital
  • Sir Charles Gairdner Hospital, Perth
  • David Maddison Clincial Sciences
  • Institut Jules Bordet
  • Hopital Universitaire Erasme
  • Cliniques Universitaires Saint-Luc
  • Universitair Ziekenhuis Antwerpen
  • Clinique Notre Dame de Grace
  • U.Z. Gasthuisberg
  • National Centre of Oncology
  • University Hospital Sestre Milosrdnice
  • Charles University Hospital
  • North-Estonian Regional Hospital Cancer Centre
  • Centre Hospitalier Universitare d'Amens
  • CHR de Besancon - Hopital Saint-Jacques
  • Hopital Saint Andre
  • CHU Ambroise Pare
  • CHR de Grenoble - La Tronche
  • Centre Hospitalier Regional et Universitaire de Lille
  • Centre Hospital Regional Universitaire de Limoges
  • Centre Leon Berard
  • Hopital St. Eloi
  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
  • Hopital L'Archet - 2
  • Hopital Bichat - Claude Bernard
  • Hopital Saint-Louis
  • Hopital Haut Leveque
  • Centre Hospitalier Universitaire
  • Centre Eugene Marquis
  • Centre Rene Huguenin
  • Centre Hospitalier Regional et Universitaire de Saint-Etienne
  • Hopitaux Universitaire de Strasbourg
  • Centre Hospitalier Regional Metz Thionville
  • Centre Hospitalier Universitaire Bretonneau de Tours
  • Centre Alexis Vautrin
  • Institut Gustave Roussy
  • Robert Roessle Klinik
  • Saint Josef Hospital
  • Stadt. Kliniken
  • Universitaet Erlangen
  • Georg August Universitaet
  • Haematologisch-Onkologische Praxis Altona
  • Universitaets-Hautklinik Heidelberg
  • Universitaet Leipzig - Chirurgische Klinik und Poliklinik I
  • Otto - Von - Guericke - Universitaet Magdeburg
  • Klinikum der Stadt Mannheim
  • Universitaet Wuerzburg/Hautkrankheiten
  • Rambam Medical Center
  • Wolfson Medical Center
  • Tel-Aviv Sourasky Medical Center
  • Centro di Riferimento Oncologico - Aviano
  • Ospendale S.M. Annunziata-A.S.DI Firenze
  • Istituto Nazionale per la Ricerca sul Cancro
  • Istituto Nazionale per lo Studio e la Cura dei Tumori
  • European Institute of Oncology - Chemo Prevention
  • Istituto Nazionale per lo Studio e la Cura dei Tumori
  • Istituto Regina Elena
  • Universita Degli Studi di Torino
  • Vrije Universiteit Medisch Centrum
  • Leiden University Medical Center
  • University Medical Center Nijmegen
  • Erasmus University Medical Center
  • Academisch Ziekenhuis Utrecht
  • Great Poland Cancer Center
  • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
  • Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa
  • Instituto Portugues de Oncologia Centro do Porto, SA
  • Institute of Oncology, Ljubljana
  • Hospital Universitario 12 de Octubre
  • Hospital Clinico Universitario
  • Kantonspital Aarau
  • Inselspital, Bern
  • Ratisches Kantons und Regionalspital
  • UniversitaetsSpital
  • Vakif Gureba Training Hospital
  • Ege University Medical School
  • Bristol Haematology and Oncology Centre
  • Addenbrooke's NHS Trust
  • Cheltenham General Hospital
  • Royal Devon and Exeter Hospital
  • Royal Surrey County Hospital
  • Princess Royal Hospital
  • St. James's Hospital
  • Leicester Royal Infirmary
  • Saint Bartholomew's Hospital
  • Royal Free Hospital
  • Guy's and St. Thomas' Hospitals NHS Trust
  • St. George's Hospital
  • Royal Marsden NHS Trust
  • Clatterbridge Centre for Oncology NHS Trust
  • Newcastle General Hospital
  • Salisbury District Hospital
  • Weston Park Hospital
  • Southampton General Hospital
  • Royal Marsden Hospital
  • Southend NHS Trust Hospital
  • Belfast City Hospital Trust
  • Ninewells Hospital and Medical School
  • Western Infirmary
  • Velindre Cancer Center at Velinde Hospital
  • Selly Oak Hospital at University Hospital NHS Trust
  • Churchill Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

observation

pegylated interferon alfa

Arm Description

5 years observation + 5 years follow up

5 years pegylated interferon alfa + 5 years follow up

Outcomes

Primary Outcome Measures

distant-metastasis free-survival (DMFS)
distant-metastasis free-survival (DMFS) after randomization

Secondary Outcome Measures

survival
duration of survival: time from randomization until death, whatever the cause
toxicity
toxicity

Full Information

First Posted
September 11, 2000
Last Updated
February 9, 2015
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00006249
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 Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2000 (undefined)
Primary Completion Date
August 2003 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
stage III melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1258 (Actual)

8. Arms, Groups, and Interventions

Arm Title
observation
Arm Type
No Intervention
Arm Description
5 years observation + 5 years follow up
Arm Title
pegylated interferon alfa
Arm Type
Experimental
Arm Description
5 years pegylated interferon alfa + 5 years follow up
Intervention Type
Biological
Intervention Name(s)
pegylated interferon alfa
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Primary Outcome Measure Information:
Title
distant-metastasis free-survival (DMFS)
Description
distant-metastasis free-survival (DMFS) after randomization
Time Frame
from randomization
Secondary Outcome Measure Information:
Title
survival
Description
duration of survival: time from randomization until death, whatever the cause
Time Frame
from randomization till death
Title
toxicity
Description
toxicity
Time Frame
from randomization
Other Pre-specified Outcome Measures:
Title
quality of life
Description
Quality of life evaluation
Time Frame
from randomization

10. Eligibility

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

12. IPD Sharing Statement

Citations:
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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.
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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.
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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.
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Interferon Alfa Following Surgery in Treating Patients With Stage III Melanoma

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