Clinical trial · Interventional
Trial of Surgical Excision Margins in Thick Primary Melanoma
A Randomised Trial of Surgical Excision Margins for Thick Primary Cutaneous Melanoma (>2 mm). A Multicenter Trial Comparing 2-cm vs 4-cm
NCT01183936CI-TRIAL-00003813completedN/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 effects of an excision margin of 2 cm versus 4 cm for patients with primary cutaneous malignant melanoma (CMM). Study hypothesis: The hypothesis is that there is no difference between the two treatment arms measured as overall survival and recurrence free 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
- Overall survival
Secondary outcomes (1)
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 (1)
- DERIVEDGillgren 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