Clinical trial · Interventional
Trial of Surgical Excision Margins in Thick Primary Melanoma - 2
Long-term Follow-up of Survival in Surgical Resected Invasive Cutaneous Melanomas: Comparing 2-cm Versus 4 -cm Resection Margins - a Randomized, Multicenter Trial
NCT03638492CI-TRIAL-00034444completedN/AClinicalTrials.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)
Objectives: The purpose of this study was to assess the long-term follow-up of the overall and melanoma-specific survival in the randomised, open-lable multicenter trial (NTC NCT01183936) comparing excision margin of 2 cm versus 4 cm for patients with primary cutaneous malignant melanoma (CMM) thicker than 2 mm. Study hypothesis: The hypothesis is that there is no difference between the two treatment arms measured as melanoma-specific survival and overall survival.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Surgery | — | UNRESOLVED | — |
| Treatment Outcome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2-cm margin | Procedure | — | UNRESOLVED |
| 4-cm margin | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 2 cm margin of excision
- description
- Patients with CMM \>2 mm treated with an excision of 2-cm.
- interventionNames
- Procedure: 2-cm margin
- type
- ACTIVE_COMPARATOR
- label
- 4 cm margin of excision
- description
- Patients with CMM \>2 mm treated with an excision of 4-cm.
- interventionNames
- Procedure: 4-cm margin
Primary outcomes (1)
- measure
- Melanoma-specific survival
- timeFrame
- 24.9 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Melanoma \>2 mm * Age ≤ 75 yr * Patients operated on with ≤ 2-cm at diagnosis * Final surgery planned within 8 weeks after date of diagnosis * Patient fit for surgery * Signed patient consent form Exclusion Criteria: * Melanoma on hand, foot, head-neck or ano-genital regions * The presence of in-transit- regional and/or distant spread of the disease * Illness making patient unfit for surgery * Previous malignancies except basal cell- and in-situ colli uteri cancer
References
Publications (6)
- BACKGROUNDGillgren P, Drzewiecki KT, Niin M, Gullestad HP, Hellborg H, Mansson-Brahme E, Ingvar C, Ringborg U. 2-cm versus 4-cm surgical excision margins for primary cutaneous melanoma thicker than 2 mm: a randomised, multicentre trial. Lancet. 2011 Nov 5;378(9803):1635-42. doi: 10.1016/S0140-6736(11)61546-8. Epub 2011 Oct 23. PMID 22027547
- BACKGROUNDThomas JM, Newton-Bishop J, A'Hern R, Coombes G, Timmons M, Evans J, Cook M, Theaker J, Fallowfield M, O'Neill T, Ruka W, Bliss JM; United Kingdom Melanoma Study Group; British Association of Plastic Surgeons; Scottish Cancer Therapy Network. Excision margins in high-risk malignant melanoma. N Engl J Med. 2004 Feb 19;350(8):757-66. doi: 10.1056/NEJMoa030681. PMID 14973217
- BACKGROUNDHayes AJ, Maynard L, Coombes G, Newton-Bishop J, Timmons M, Cook M, Theaker J, Bliss JM, Thomas JM; UK Melanoma Study Group; British Association of Plastic; Reconstructive and Aesthetic Surgeons, and the Scottish Cancer Therapy Network. Wide versus narrow excision margins for high-risk, primary cutaneous melanomas: long-term follow-up of survival in a randomised trial. Lancet Oncol. 2016 Feb;17(2):184-192. doi: 10.1016/S1470-2045(15)00482-9. Epub 2016 Jan 12. PMID 26790922
- BACKGROUNDEthun CG, Delman KA. The importance of surgical margins in melanoma. J Surg Oncol. 2016 Mar;113(3):339-45. doi: 10.1002/jso.24111. Epub 2015 Dec 10. PMID 26662509
- BACKGROUNDSladden MJ, Nieweg OE, Howle J, Coventry BJ, Thompson JF. Updated evidence-based clinical practice guidelines for the diagnosis and management of melanoma: definitive excision margins for primary cutaneous melanoma. Med J Aust. 2018 Feb 19;208(3):137-142. doi: 10.5694/mja17.00278. PMID 29438650
- DERIVEDUtjes D, Malmstedt J, Teras J, Drzewiecki K, Gullestad HP, Ingvar C, Eriksson H, Gillgren P. 2-cm versus 4-cm surgical excision margins for primary cutaneous melanoma thicker than 2 mm: long-term follow-up of a multicentre, randomised trial. Lancet. 2019 Aug 10;394(10197):471-477. doi: 10.1016/S0140-6736(19)31132-8. Epub 2019 Jul 4.