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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00006249
Registration number
NCT00006249
Ethics application status
Date submitted
11/09/2000
Date registered
27/01/2003
Date last updated
10/02/2015
Titles & IDs
Public title
Interferon Alfa Following Surgery in Treating Patients With Stage III Melanoma
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Scientific title
PEG-Intron Observation After Regional Lymph Node Dissection in AJCC Stage III (TxN1-2MO) Melanoma Patients: a Randomized Phase III Trial
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Secondary ID [1]
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EORTC-18991
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Secondary ID [2]
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EORTC-18991
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Melanoma (Skin)
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Condition category
Condition code
Cancer
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Malignant melanoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
No intervention: observation - 5 years observation + 5 years follow up
Experimental: pegylated interferon alfa - 5 years pegylated interferon alfa + 5 years follow up
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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distant-metastasis free-survival (DMFS)
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Assessment method [1]
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distant-metastasis free-survival (DMFS) after randomization
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Timepoint [1]
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from randomization
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Secondary outcome [1]
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survival
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Assessment method [1]
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duration of survival: time from randomization until death, whatever the cause
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Timepoint [1]
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from randomization till death
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Secondary outcome [2]
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toxicity
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Assessment method [2]
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toxicity
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from randomization
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Eligibility
Key inclusion 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
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Minimum age
18
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Maximum age
70
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Masking / blinding
Open (masking not used)
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2000
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
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Accrual to date
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Final
1258
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Recruitment in Australia
Recruitment state(s)
VIC,WA
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Recruitment hospital [1]
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Peter MacCallum Cancer Institute - East Melbourne
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Austin and Repatriation Medical Centre - Heidelberg West
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Royal Perth Hospital - Perth
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Sir Charles Gairdner Hospital, Perth - Perth
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David Maddison Clincial Sciences - Newcastle
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8006 - East Melbourne
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3081 - Heidelberg West
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Recruitment postcode(s) [3]
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6000 - Perth
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Recruitment postcode(s) [4]
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6009 - Perth
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NSW 2300 - Newcastle
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Oxford
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Funding & Sponsors
Primary sponsor type
Other
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Name
European Organisation for Research and Treatment of Cancer - EORTC
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00006249
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Trial related presentations / publications
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-a2b (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. Erratum In: J Clin Oncol. 2009 Sep 20;27(27):4630. Dosage error in published abstract; MEDLINE/PubMed abstract corrected. 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.
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Public notes
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Contacts
Principal investigator
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Alexander M. M. Eggermont, MD, PhD
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Address
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Daniel Den Hoed Cancer Center at Erasmus Medical Center
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Eggermont AM, Suciu S, Santinami M, et al.: EORTC ...
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Bouwhuis MG, Suciu S, Testori A, Kruit WH, Sales F...
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Eggermont AM, Bouwhuis MG, Kruit WH, Testori A, te...
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Bottomley A, Coens C, Suciu S, Santinami M, Kruit ...
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Fusi A, Collette S, Busse A, Suciu S, Rietz A, San...
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Eggermont AM, Suciu S, Santinami M, Testori A, Kru...
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Eggermont AM, Suciu S, Santinami M, et al.: EORTC ...
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Results not provided in
https://clinicaltrials.gov/study/NCT00006249
Download to PDF