Clinical trial · Interventional
Nordic Adjuvant IFN Melanoma Trial
Nordic Randomized Phase III Trial of Two Different Durations of Adjuvant Therapy With Intermediate-dose Interferon Alfa-2b in Patients With High-risk Melanoma
NCT01259934CI-TRIAL-00004193completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adjuvant Therapy | — | UNRESOLVED | — |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interferon-alpha2b - 1 year | Drug | — | UNRESOLVED |
| Interferon-alpha2b - 2 years | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * T4 N0 M0 - Thick primary melanoma: \> 4.0 mm Breslow depth, without lymph node involvement, or * Tx N1-2 M0 Primary melanoma of any thickness with regional lymph node metastases confirmed by lymphadenectomy, or * Tx N1-2 M0 Recurrent melanoma in regional lymph node(s) confirmed by lymphadenectomy. * ECOG performance status of 0-1 * No active medical or psychiatric disorder requiring therapy that would prevent completion of protocol * Written informed consent Exclusion Criteria: * Patients with unknown primary site of melanoma or primary melanoma originating apart from the skin, except subungual melanoma * Patients who have clinical, radiological/laboratory or pathological evidence of incompletely resected melanoma or distant metastatic disease * Patients who have had prior adjuvant radiotherapy, chemotherapy, immunotherapy including preoperative infusion or perfusion therapy * Female patients who are pregnant or lactating
References
Publications (3)
- BACKGROUNDBouwhuis 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 19509353
- DERIVEDPrasmickaite 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 25832001
- DERIVEDHansson 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. PMID 21256809