Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-27 @ 11:49 PM
Study NCT ID:
NCT01259934
Status:
COMPLETED
Last Update Posted:
2010-12-14
First Post:
2010-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nordic Adjuvant IFN Melanoma Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000614170', 'term': 'Interferon-alpha2b'}, {'id': 'D007438', 'term': 'Introns'}], 'ancestors': [{'id': 'D021901', 'term': 'DNA, Intergenic'}, {'id': 'D040481', 'term': 'Genome Components'}, {'id': 'D016678', 'term': 'Genome'}, {'id': 'D040342', 'term': 'Genetic Structures'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}, {'id': 'D040461', 'term': 'Gene Components'}, {'id': 'D005796', 'term': 'Genes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 855}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1996-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-13', 'studyFirstSubmitDate': '2010-12-10', 'studyFirstSubmitQcDate': '2010-12-13', 'lastUpdatePostDateStruct': {'date': '2010-12-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Evaluated at regular intervals: every 3 months for 2 years, every 6 months up to 5 years and yearly up to 10 years following randomization. Actual median follow-up is 72.4 months', 'description': 'All registered deaths, not only melanoma-specific.'}], 'secondaryOutcomes': [{'measure': 'Relapse free survival', 'timeFrame': 'Evaluated at regular intervals', 'description': 'Time from randomization to date of first reported melanoma recurrence or death'}, {'measure': 'Safety-toxicity', 'timeFrame': 'Regular evaluations', 'description': 'All toxicities and SAEs are recorded and classified according to CTC v2.0 criteria'}, {'measure': 'Health related quality of life', 'timeFrame': 'Regular evaluations', 'description': 'Recorded by using the EORTC QLQ-C30 questionnaire at nine time points during treatment and follow-up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Randomized Phase III trial', 'Adjuvant therapy', 'Interferon', 'Melanoma'], 'conditions': ['Melanoma', 'Adjuvant Therapy']}, 'referencesModule': {'references': [{'pmid': '19509353', 'type': 'BACKGROUND', '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.'}, {'pmid': '25832001', 'type': 'DERIVED', 'citation': 'Prasmickaite L, Berge G, Bettum IJ, Aamdal S, Hansson J, Bastholt L, Oijordsbakken M, Boye K, Maelandsmo GM. Evaluation of serum osteopontin level and gene polymorphism as biomarkers: analyses from the Nordic Adjuvant Interferon alpha Melanoma trial. Cancer Immunol Immunother. 2015 Jun;64(6):769-76. doi: 10.1007/s00262-015-1686-4. Epub 2015 Apr 2.'}, {'pmid': '21256809', 'type': 'DERIVED', 'citation': 'Hansson J, Aamdal S, Bastholt L, Brandberg Y, Hernberg M, Nilsson B, Stierner U, von der Maase H; Nordic Melanoma Cooperative Group. Two different durations of adjuvant therapy with intermediate-dose interferon alfa-2b in patients with high-risk melanoma (Nordic IFN trial): a randomised phase 3 trial. Lancet Oncol. 2011 Feb;12(2):144-52. doi: 10.1016/S1470-2045(10)70288-6. Epub 2011 Jan 20.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effect of giving adjuvant treatment with intermediate doses of interferon-alpha2b to patients operated for high risk melanoma. Patients are randomly assigned to either observation only or interferon treatment for 2 different durations. The outcome with respect to overall survival, relapse-free survival, side effects and quality of life is analysed.', 'detailedDescription': 'This is an open multicenter, prospective randomised phase III trial evaluating the efficacy of two different schedules of Interferon-alpha2b (IFN-alpha2b) administered in an adjuvant setting after adequate surgery in high risk cutaneous melanoma patients (T4N0M0/TxN1-2M0). The patients have been operated for either a thick primary melanoma (\\> 4 mm) without evidence of distant metastasis or have undergone surgery for regional lymph node metastases.\n\nThe study consists of a control arm (A) and two treatment arms, B and C. The outcome in arms B and C with adjuvant treatment with IFN-alpha2b will be compared to the outcome of arm A in which the patients will only be observed after the surgery. The primary endpoint is overall survival. Secondary endpoints are relapse-free survival, safety-toxicity and health-related quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* T4 N0 M0 - Thick primary melanoma: \\> 4.0 mm Breslow depth, without lymph node involvement, or\n* Tx N1-2 M0 Primary melanoma of any thickness with regional lymph node metastases confirmed by lymphadenectomy, or\n* Tx N1-2 M0 Recurrent melanoma in regional lymph node(s) confirmed by lymphadenectomy.\n* ECOG performance status of 0-1\n* No active medical or psychiatric disorder requiring therapy that would prevent completion of protocol\n* Written informed consent\n\nExclusion Criteria:\n\n* Patients with unknown primary site of melanoma or primary melanoma originating apart from the skin, except subungual melanoma\n* Patients who have clinical, radiological/laboratory or pathological evidence of incompletely resected melanoma or distant metastatic disease\n* Patients who have had prior adjuvant radiotherapy, chemotherapy, immunotherapy including preoperative infusion or perfusion therapy\n* Female patients who are pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT01259934', 'briefTitle': 'Nordic Adjuvant IFN Melanoma Trial', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Nordic Randomized Phase III Trial of Two Different Durations of Adjuvant Therapy With Intermediate-dose Interferon Alfa-2b in Patients With High-risk Melanoma', 'orgStudyIdInfo': {'id': 'Nordic-IFN-melanoma trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Arm A', 'description': 'Observation only - no therapy'}, {'type': 'EXPERIMENTAL', 'label': 'Arm B Interferon 1 year', 'description': 'Interferon Therapy: Induction: IFN-alfa2b, 10 MU (flat dose), SC, 5 days/week, 4 weeks Maintenance: IFN-alfa2b, 10 MU (flat dose), 3 days/week, SC, 12 months', 'interventionNames': ['Drug: Interferon-alpha2b - 1 year']}, {'type': 'EXPERIMENTAL', 'label': 'Arm C Interferon 2 years', 'description': '"Two year arm" Induction: IFN-alfa2b, 10 MU (flat dose), SC, 5 days/week, 4 weeks Maintenance: IFN-alfa2b, 10 MU (flat dose), 3 days/week, SC, 24 months', 'interventionNames': ['Drug: Interferon-alpha2b - 2 years']}], 'interventions': [{'name': 'Interferon-alpha2b - 1 year', 'type': 'DRUG', 'otherNames': ['Intron-A'], 'description': 'Induction: IFN-alpha2b, 10 MU (flat dose), SC, 5 days/week, 4 weeks Maintenance: IFN-alpha2b, 10 MU (flat dose), 3 days/week, SC, 12 months', 'armGroupLabels': ['Arm B Interferon 1 year']}, {'name': 'Interferon-alpha2b - 2 years', 'type': 'DRUG', 'otherNames': ['Intron-A'], 'description': 'Induction: IFN-alfa2b, 10 MU (flat dose), SC, 5 days/week, 4 weeks Maintenance: IFN-alfa2b, 10 MU (flat dose), 3 days/week, SC, 24 months', 'armGroupLabels': ['Arm C Interferon 2 years']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S-171 76', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Institutet, Karolinska University Hospital,', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Johan Hansson, MD,PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Karolinska Institutet'}, {'name': 'Steinar Aamdal, MD. PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital, Oslo, Norway'}, {'name': 'Lars Bastholt, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Odense University Hospital'}, {'name': 'Micaela Hernberg, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helsinki University Central Hospital, Helsinki, Finland'}, {'name': 'Ulrika Stierner, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sahlgrenska University Hospital'}, {'name': 'Hans von der Maase, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Copenhagen University Hospital, Copenhagen, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Johan Hansson, PI', 'oldOrganization': 'Department of Oncology-Pathology, Karolinska Institutet'}}}}