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High-Dose or Low-Dose Interferon Alfa Compared With No Further Therapy 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
recombinant interferon alfa
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

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

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Cutaneous melanoma in one of the following categories: T4, N0, M0 Deep primary tumor with Breslow depth greater than 4.0 cm Tx, N1, M0 Primary tumor with regional lymph node metastases found at lymphadenectomy but clinically undetectable Tx, N2, M0 Clinically apparent regional lymph node metastases (synchronous or metachronous) confirmed by lymphadenectomy Definitive surgical resection and lymphadenectomy with pathologically confirmed adequate surgical margins required Minimum 2 cm margin for primary lesions with Breslow depth greater than 2 mm Distal interphalangeal amputation required for subungual melanomas No primary melanoma originating apart from the skin No multiple in transit metastases in an extremity No lymph node involvement outside the operative area resected by radical neck, axillary lymph node, or ilioinguinal dissection PATIENT CHARACTERISTICS: Age: 16 to 75 Performance status: ECOG 0 or 1 Hematopoietic: WBC at least 4,000 Platelets at least 125,000 Hemoglobin at least 9.8 g/dL (6.1 mmol/L) Hepatic: Bilirubin no greater than 2 times normal AST no greater than 2 times normal Renal: Creatinine no greater than 1.6 mg/dL (140 micromoles/L) Cardiovascular: No ventricular or supraventricular arrhythmia requiring treatment No congestive heart failure (NYHA class 3/4 status) Other: No uncontrolled infection No requirement for ongoing steroids, NSAIDs, or other immunomodulators No organic brain syndrome or significant impairment of basal cognitive function No psychiatric disorder that would preclude study participation or would be exacerbated by study therapy (e.g., depression) No second malignancy except: In situ cervical cancer Nonmelanomatous skin cancer No pregnant or nursing women PRIOR CONCURRENT THERAPY: No prior treatment on this protocol for patients with recurrent melanoma at regional lymph nodes No preoperative infusion or perfusion therapy Biologic therapy: No prior adjuvant immunotherapy Chemotherapy: No prior adjuvant systemic chemotherapy No prior anthracyclines Endocrine therapy: Not specified Radiotherapy: No prior adjuvant radiotherapy Surgery: See Disease Characteristics

Sites / Locations

  • Krankenhaus der Elisabethinen
  • Landeskrankenanstalten - Salzburg
  • Institut Jules Bordet
  • Cliniques Universitaires Saint-Luc
  • Hopital Universitaire Erasme
  • Centre Hospitalier Notre Dame - Reine Fabiola
  • Universitair Ziekenhuis Antwerpen
  • Universitair Ziekenhuis Gent
  • U.Z. Gasthuisberg
  • Alexander's University Hospital
  • National Centre of Oncology
  • University Hospital Sestre Milosrdnice
  • Estonian Cancer Center
  • Tampere University Hospital
  • Turku University Central Hospital
  • CHU de Bordeaux - Hopital Pellegrin
  • Institut Bergonie
  • CHU Ambroise Pare
  • CHRU de Caen
  • Centre Leon Berard
  • Centre Antoine Lacassagne
  • Hopital L'Archet - 2
  • Hopital Bichat-Claude Bernard
  • Hopital Saint-Louis
  • Hopital Cochin
  • Hopital Haut Leveque
  • Centre Eugene Marquis
  • Centre Rene Huguenin
  • Centre Hospitalier Regional et Universitaire de Saint-Etienne
  • Hopitaux Universitaire de Strasbourg
  • Centre Hospitalier Regional Metz Thionville
  • Institut Claudius Regaud
  • Centre Hospitalier Universitaire Bretonneau de Tours
  • Institut Gustave Roussy
  • Universitaetsklinikum Benjamin Franklin
  • Robert Roessle Klinik
  • Universitaets-Augenklinik - Erlangen
  • Georg August Universitaet
  • Universitats-Krankenhaus Eppendorf
  • Haematologisch-Onkologische Praxis Altona
  • Department of Dematology, Hannover Medical School
  • Universitaets-Hautklinik Heidelberg
  • Universitatsklinik, Saarland
  • III Medizinische Klinik Mannheim
  • Klinikum der Universitat Regensburg
  • Universitatshautklinik Eberhard - Karlsuniversitat Tubingen
  • Department of Dermatology
  • Universitaet Wuerzburg/Hautkrankheiten
  • Wolfson Medical Center
  • Tel-Aviv Medical Center-Ichilov Hospital
  • Istituto Europeo Di Oncologia
  • Academisch Ziekenhuis der Vrije Universiteit
  • Antoni van Leeuwenhoekhuis
  • Academisch Ziekenhuis Groningen
  • Leiden University Medical Center
  • University Medical Center Nijmegen
  • Rotterdam Cancer Institute
  • Academisch Ziekenhuis Utrecht
  • Medical University of Gdansk
  • Maria Sklodowska-Curie M.C.C.I.O. Krakow
  • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
  • Instituto Portugues de Oncologia de Francisco Gentil
  • Instituto Portugues de Oncologia do Porto
  • Russian Academy of Medical Sciences Cancer Research Center
  • Institute of Oncology and Radiology of Serbia
  • National Cancer Institute - Bratislava
  • Hospital Clinic y Provincial de Barcelona
  • Hospital Clinico Universitario
  • Huddinge Hospital
  • Ospedale San Giovanni
  • Inselspital, Bern
  • Ratisches Kantons und Regionalspital
  • Centre Hospitalier Universitaire Vaudois
  • Kantonsspital - Saint Gallen
  • Universitaetsspital
  • Cukurova University School of Medicine
  • Vakif Gureba Training Hospital
  • Istanbul University-Institute of Oncology
  • Cerrahpasa Medical School
  • Ege University Medical School
  • Bristol Oncology Centre
  • Addenbrooke's NHS Trust
  • St. James's Hospital
  • Royal Marsden NHS Trust
  • Derriford Hospital
  • Beatson Oncology Centre

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
November 15, 2011
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00002763
Brief Title
High-Dose or Low-Dose Interferon Alfa Compared With No Further Therapy Following Surgery in Treating Patients With Stage III Melanoma
Official Title
POST-OPERATIVE ADJUVANT INTERFERON-ALFA-2B (INTRON-A) TREATMENT AFTER RESECTION OF THICK PRIMARY MELANOMA AND/OR REGIONAL LYMPHNODE METASTASES 'INTERMEDIATE-HIGH DOSE' VS INTERMEDIATE-LOW DOSE' IFN-ALFA VS OBSERVATION: A 3-ARM MULTICENTER RANDOMIZED PHASE III TRIAL
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

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 cancer cells. It is not known whether giving high-dose or low-dose interferon alfa is more effective than no further therapy in treating patients with stage III melanoma. PURPOSE: Randomized phase III trial to compare the effectiveness of high- or low-dose interferon alfa with that of no further therapy following surgery in treating patients who have stage III melanoma.
Detailed Description
OBJECTIVES: I. Evaluate the time to distant metastasis, death due to melanoma, and overall survival in patients with high-risk stage III melanoma treated with 10 MU of interferon alfa (IFN-A) for 4 weeks followed by 1 year of IFN-A at 10 MU three times per week vs. 2 years of IFN-A at 5 MU three times per week vs. observation alone. II. Assess the toxicity associated with IFN-A. III. Compare the quality of life, costs, and compliance associated with each treatment regimen. OUTLINE: Randomized study. Following definitive surgical resection, patients are randomly assigned in a 2:2:1 ratio to Arms A, B, and C, respectively. Arm A: Biological Response Modifier Therapy. Interferon alfa-2b (Schering), IFN-A, NSC-377523. Higher dose. Arm B: Biological Response Modifier Therapy. IFN-A. Lower dose. Arm C: Control. Observation. PROJECTED ACCRUAL: A total of 1,000 patients will be entered over approximately 4 years in this multicenter study.

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, recurrent melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
recombinant interferon alfa

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Cutaneous melanoma in one of the following categories: T4, N0, M0 Deep primary tumor with Breslow depth greater than 4.0 cm Tx, N1, M0 Primary tumor with regional lymph node metastases found at lymphadenectomy but clinically undetectable Tx, N2, M0 Clinically apparent regional lymph node metastases (synchronous or metachronous) confirmed by lymphadenectomy Definitive surgical resection and lymphadenectomy with pathologically confirmed adequate surgical margins required Minimum 2 cm margin for primary lesions with Breslow depth greater than 2 mm Distal interphalangeal amputation required for subungual melanomas No primary melanoma originating apart from the skin No multiple in transit metastases in an extremity No lymph node involvement outside the operative area resected by radical neck, axillary lymph node, or ilioinguinal dissection PATIENT CHARACTERISTICS: Age: 16 to 75 Performance status: ECOG 0 or 1 Hematopoietic: WBC at least 4,000 Platelets at least 125,000 Hemoglobin at least 9.8 g/dL (6.1 mmol/L) Hepatic: Bilirubin no greater than 2 times normal AST no greater than 2 times normal Renal: Creatinine no greater than 1.6 mg/dL (140 micromoles/L) Cardiovascular: No ventricular or supraventricular arrhythmia requiring treatment No congestive heart failure (NYHA class 3/4 status) Other: No uncontrolled infection No requirement for ongoing steroids, NSAIDs, or other immunomodulators No organic brain syndrome or significant impairment of basal cognitive function No psychiatric disorder that would preclude study participation or would be exacerbated by study therapy (e.g., depression) No second malignancy except: In situ cervical cancer Nonmelanomatous skin cancer No pregnant or nursing women PRIOR CONCURRENT THERAPY: No prior treatment on this protocol for patients with recurrent melanoma at regional lymph nodes No preoperative infusion or perfusion therapy Biologic therapy: No prior adjuvant immunotherapy Chemotherapy: No prior adjuvant systemic chemotherapy No prior anthracyclines Endocrine therapy: Not specified Radiotherapy: No prior adjuvant radiotherapy Surgery: See Disease Characteristics
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
Krankenhaus der Elisabethinen
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Landeskrankenanstalten - Salzburg
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Institut Jules Bordet
City
Brussels (Bruxelles)
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels (Bruxelles)
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Hopital Universitaire Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Centre Hospitalier Notre Dame - Reine Fabiola
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
B-2650
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Ghent (Gent)
ZIP/Postal Code
B-9000
Country
Belgium
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Alexander's University Hospital
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
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
Estonian Cancer Center
City
Tallinn
ZIP/Postal Code
11619
Country
Estonia
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33521
Country
Finland
Facility Name
Turku University Central Hospital
City
Turku
ZIP/Postal Code
FIN-2-0521
Country
Finland
Facility Name
CHU de Bordeaux - Hopital Pellegrin
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CHU Ambroise Pare
City
Boulogne Billancourt
ZIP/Postal Code
F-92104
Country
France
Facility Name
CHRU de Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
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 Cochin
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
Hopital Haut Leveque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35062
Country
France
Facility Name
Centre Rene Huguenin
City
Saint Cloud
ZIP/Postal Code
92210
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
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31052
Country
France
Facility Name
Centre Hospitalier Universitaire Bretonneau de Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France
Facility Name
Universitaetsklinikum Benjamin Franklin
City
Berlin
ZIP/Postal Code
D-12200
Country
Germany
Facility Name
Robert Roessle Klinik
City
Berlin
ZIP/Postal Code
D-13122
Country
Germany
Facility Name
Universitaets-Augenklinik - 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
Universitats-Krankenhaus Eppendorf
City
Hamburg
ZIP/Postal Code
D-20246
Country
Germany
Facility Name
Haematologisch-Onkologische Praxis Altona
City
Hamburg
ZIP/Postal Code
D-22765
Country
Germany
Facility Name
Department of Dematology, Hannover Medical School
City
Hannover
ZIP/Postal Code
D-30449
Country
Germany
Facility Name
Universitaets-Hautklinik Heidelberg
City
Heidelberg
ZIP/Postal Code
D-69115
Country
Germany
Facility Name
Universitatsklinik, Saarland
City
Homburg/Saar
ZIP/Postal Code
D-66421
Country
Germany
Facility Name
III Medizinische Klinik Mannheim
City
Mannheim
ZIP/Postal Code
D-68305
Country
Germany
Facility Name
Klinikum der Universitat Regensburg
City
Regensburg
ZIP/Postal Code
DOH-9-3053
Country
Germany
Facility Name
Universitatshautklinik Eberhard - Karlsuniversitat Tubingen
City
Tubingen
ZIP/Postal Code
DOH-7-2076
Country
Germany
Facility Name
Department of Dermatology
City
Ulm
ZIP/Postal Code
DOH-8-9081
Country
Germany
Facility Name
Universitaet Wuerzburg/Hautkrankheiten
City
Wuerzburg
ZIP/Postal Code
D-97080
Country
Germany
Facility Name
Wolfson Medical Center
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Tel-Aviv Medical Center-Ichilov Hospital
City
Tel-Aviv
ZIP/Postal Code
62995
Country
Israel
Facility Name
Istituto Europeo Di Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Academisch Ziekenhuis der Vrije Universiteit
City
Amsterdam
ZIP/Postal Code
1007 MB
Country
Netherlands
Facility Name
Antoni van Leeuwenhoekhuis
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Academisch Ziekenhuis Groningen
City
Groningen
ZIP/Postal Code
9713 EZ
Country
Netherlands
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2300 ZA
Country
Netherlands
Facility Name
University Medical Center Nijmegen
City
Nijmegen
ZIP/Postal Code
NL-6252 HB
Country
Netherlands
Facility Name
Rotterdam Cancer Institute
City
Rotterdam
ZIP/Postal Code
3075 EA
Country
Netherlands
Facility Name
Academisch Ziekenhuis Utrecht
City
Utrecht
ZIP/Postal Code
3508 GA
Country
Netherlands
Facility Name
Medical University of Gdansk
City
Gdansk
ZIP/Postal Code
80-211
Country
Poland
Facility Name
Maria Sklodowska-Curie M.C.C.I.O. Krakow
City
Krakow (Cracow)
ZIP/Postal Code
31-115
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
City
Lisbon
ZIP/Postal Code
1093
Country
Portugal
Facility Name
Instituto Portugues de Oncologia do Porto
City
Porto
ZIP/Postal Code
4200
Country
Portugal
Facility Name
Russian Academy of Medical Sciences Cancer Research Center
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Institute of Oncology and Radiology of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
National Cancer Institute - Bratislava
City
Bratislava
ZIP/Postal Code
833 10
Country
Slovakia
Facility Name
Hospital Clinic y Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Clinico Universitario
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Huddinge Hospital
City
Huddinge
ZIP/Postal Code
S-141 86
Country
Sweden
Facility Name
Ospedale San Giovanni
City
Bellinzona
ZIP/Postal Code
CH-6500
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
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
CH-1011
Country
Switzerland
Facility Name
Kantonsspital - Saint Gallen
City
Saint Gallen
ZIP/Postal Code
CH-9007
Country
Switzerland
Facility Name
Universitaetsspital
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland
Facility Name
Cukurova University School of Medicine
City
Adana
ZIP/Postal Code
01330
Country
Turkey
Facility Name
Vakif Gureba Training Hospital
City
Istanbul
ZIP/Postal Code
34296
Country
Turkey
Facility Name
Istanbul University-Institute of Oncology
City
Istanbul
ZIP/Postal Code
34390
Country
Turkey
Facility Name
Cerrahpasa Medical School
City
Istanbul
Country
Turkey
Facility Name
Ege University Medical School
City
Izmir
ZIP/Postal Code
35220
Country
Turkey
Facility Name
Bristol 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
St. James's Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Royal Marsden NHS Trust
City
London
State/Province
England
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
State/Province
England
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Beatson Oncology Centre
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G11 6NT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22056637
Citation
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.
Results Reference
background
PubMed Identifier
19509353
Citation
Bouwhuis MG, Suciu S, Collette S, Aamdal S, Kruit WH, Bastholt L, Stierner U, Sales F, Patel P, Punt CJ, Hernberg M, Spatz A, ten Hagen TL, Hansson J, Eggermont AM; EORTC Melanoma Group and the Nordic Melanoma Group. Autoimmune antibodies and recurrence-free interval in melanoma patients treated with adjuvant interferon. J Natl Cancer Inst. 2009 Jun 16;101(12):869-77. doi: 10.1093/jnci/djp132. Epub 2009 Jun 9.
Results Reference
background
PubMed Identifier
12862495
Citation
Eggermont AM, Punt CJ. Does adjuvant systemic therapy with interferon-alpha for stage II-III melanoma prolong survival? Am J Clin Dermatol. 2003;4(8):531-6. doi: 10.2165/00128071-200304080-00002.
Results Reference
background
PubMed Identifier
21546857
Citation
Bouwhuis MG, Collette S, Suciu S, de Groot ER, Kruit WH, Ten Hagen TL, Aarden LA, Eggermont AM, Swaak AJ; EORTC Melanoma Group. Changes of ferritin and CRP levels in melanoma patients treated with adjuvant interferon-alpha (EORTC 18952) and prognostic value on treatment outcome. Melanoma Res. 2011 Aug;21(4):344-51. doi: 10.1097/CMR.0b013e328346c17f.
Results Reference
result
PubMed Identifier
21087856
Citation
Bouwhuis MG, Suciu S, Kruit W, Sales F, Stoitchkov K, Patel P, Cocquyt V, Thomas J, Lienard D, Eggermont AM, Ghanem G; European Organisation for Research and Treatment of Cancer Melanoma Group. Prognostic value of serial blood S100B determinations in stage IIB-III melanoma patients: a corollary study to EORTC trial 18952. Eur J Cancer. 2011 Feb;47(3):361-8. doi: 10.1016/j.ejca.2010.10.005. Epub 2010 Nov 17.
Results Reference
result
Citation
Bouwhuis M, Suciu S, Kruit W, et al.: Prognostic value of autoantibodies (auto-AB) in melanoma patients (pts) in the EORTC 18952 trial of adjuvant interferon (IFN) compared to observation (obs). [Abstract] J Clin Oncol 25 (Suppl 18): A-8507, 473s, 2007.
Results Reference
result
Citation
Suciu S, Ghanem G, Kruit W, et al.: Serum S-100B protein is a strong independent prognostic marker for distant-metastasis free survival (DMFS) in stage III melanoma patients: an evaluation of the EORTC randomized trial 18952 comparing IFNα versus observation. [Abstract] J Clin Oncol 25 (Suppl 18): A-8518, 476s, 2007.
Results Reference
result
PubMed Identifier
16198768
Citation
Eggermont AM, Suciu S, MacKie R, Ruka W, Testori A, Kruit W, Punt CJ, Delauney M, Sales F, Groenewegen G, Ruiter DJ, Jagiello I, Stoitchkov K, Keilholz U, Lienard D; EORTC Melanoma Group. Post-surgery adjuvant therapy with intermediate doses of interferon alfa 2b versus observation in patients with stage IIb/III melanoma (EORTC 18952): randomised controlled trial. Lancet. 2005 Oct 1;366(9492):1189-96. doi: 10.1016/S0140-6736(05)67482-X.
Results Reference
result

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High-Dose or Low-Dose Interferon Alfa Compared With No Further Therapy Following Surgery in Treating Patients With Stage III Melanoma

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