Clinical trial · Interventional
Neurotropic Melanoma of the Head and Neck
A Randomised Trial of Post-operative Radiation Therapy Following Wide Excision of Neurotropic Melanoma of the Head and Neck
- 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)
This is a 2-armed randomised controlled trial comparing surgery alone with surgery plus post-operative radiation therapy for patients with completely resected primary melanoma showing histological features of neurotropism. Uncontrolled studies suggest that this form of primary melanoma has a high risk of local recurrence and that postoperative radiation therapy may substantially reduce that risk. Patients who are eligible on the basis of the pathology of the excised melanoma will be offered the opportunity to take part in the trial. Those randomised to receive radiation therapy will be treated with a simple technique encompassing the surgical bed plus a margin. Radiation will commence within 3 months of surgery (maximum of 14 weeks from surgery to start of radiotherapy).
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observation | Other | — | UNRESOLVED |
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Radiation Therapy
- description
- Investigational Treatment
- interventionNames
- Radiation: Radiation Therapy
- type
- OTHER
- label
- Observation
- description
- Observation
- interventionNames
- Other: Observation
Primary outcomes (1)
- measure
- Time to local relapse
- timeFrame
- 5 years from the date of randomisation
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Aged 18 years or older * Has provided written informed consent for participation in this trial * Histologically confirmed neurotropic primary melanoma * Neurotropism is identified pathologically by the presence of melanoma cells around nerve sheaths (perineural invasion) or within nerves (intraneural invasion). * Occasionally, the tumour itself may form neuroid structures (termed 'neural transformation'; this is also regarded as neurotropism) * "normal"-looking nerves that appear to be "entrapped" within the tumour should not be regarded as neurotropism * Tumour located above the clavicle and below the jaw or occiput (neck primary) or above the jaw/occiput (head primary) * Complete macroscopic resection of all known disease * No previous surgery for melanoma (other than complete macroscopic resection as stated above)(i.e. Not recurrent disease) * No evidence of in-transit, nodal or distant metastases as determined by clinical examination, CT or MRI * ECOG performance status score of 2 or less * Life expectancy greater than 6 months * Patients capable of childbearing are using adequate contraception * Available for follow up Exclusion Criteria: * Women who are pregnant or lactating * Intercurrent illness that will interfere with the radiation therapy such as immunosuppression due to medication or medical condition * Clinical and/or MRI evidence of a named cranial or cervical nerve involvement by tumour * Inability to localise surgical bed on CT scans and/or surgical margins (cm) not known * Previous radical radiation therapy to the head and neck, excluding superficial radiation therapy to cutaneous SCC or basal cell carcinoma, which is not within or overlapping the tumour bed * High risk for poor compliance with therapy or follow-up as assessed by investigator * Patients with prior cancers, except: those diagnosed ≥ 5 years ago with no evidence of disease relapse and clinical expectation of relapse of less than 5%; prior successfully treated Level 1 cutaneous melanomas ≥ 2 years ago; or non-melanoma skin cancer; or carcinoma in situ of the cervix * Albinism * Participation in other clinical trials with the same primary endpoint
References
Publications (0)
Data not yet available