Neurotropic Melanoma of the Head and Neck

Completed · Not applicable

Conditions studied: Melanoma

In brief

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).

Key facts

Study ID

NCT00975520

Run by

Melanoma and Skin Cancer Trials Limited

People needed

50

Starts

2009-09-01

Expected to finish

2023-03-01

Last updated by the study team

2024-11-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Memorial Sloan Ketttering — New York, New York, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Calvary Mater Hospital — Newcastle, New South Wales, Australia
• Melanoma Institute Australia / Royal Prince Alfred Hospital — North Sydney, New South Wales, Australia
• Westmead Hospital — Westmead, New South Wales, Australia
• Wollongong Hospital — Wollongong, New South Wales, Australia
• Royal Brisbane and Womens Hospital — Herston, Queensland, Australia
• Radiation Oncology Services - Mater Centre — South Brisbane, Queensland, Australia
• Radiation Oncology Queensland (ROQ) — Toowoomba, Queensland, Australia
• Townsville Cancer Centre — Townsville, Queensland, Australia
• Genesis Care: Tugun — Tugun, Queensland, Australia
• Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• Peter MacCallum Cancer Centre — East Melbourne, Victoria, Australia
• Alfred Hospital — Melbourne, Victoria, Australia
• Norfolk and Norwich University Hosptial, NHS Foundation Trust — Norwich, United Kingdom

Full record on ClinicalTrials.gov

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