Neurotropic Melanoma of the Head and Neck (RTN2)

• Relapse free survival [ Time Frame: 5 years from date of randomisation ] [ Designated as safety issue: No ]
• Time to Relapse [ Time Frame: 5 years from date of randomisation ] [ Designated as safety issue: No ]
• Overall survival [ Time Frame: 5 years from date of randomisation ] [ Designated as safety issue: No ]
• Cancer specific survival [ Time Frame: 5 years from date of randomisation ] [ Designated as safety issue: No ]
• Patterns of relapse [ Time Frame: 5 years from date of randomisation ] [ Designated as safety issue: No ]
• Late Toxicity [ Time Frame: 5 years from date of randomisation ] [ Designated as safety issue: Yes ]

• Relapse free survival [ Time Frame: Time from randomisation to development of relpase at any site ] [ Designated as safety issue: No ]
• Time to Relapse [ Time Frame: Time from randomisation to the development of relapse at any site (local, regional and distant metastases). ] [ Designated as safety issue: No ]
• Overall survival [ Time Frame: Time from randomisation until death from any cause ] [ Designated as safety issue: No ]
• Cancer specific survival [ Time Frame: Time from registration until death from melanoma ] [ Designated as safety issue: No ]
• Patterns of relapse [ Time Frame: Time from registration to relpase ] [ Designated as safety issue: No ]
• Late Toxicity [ Time Frame: Time from randomisation to end of trial ] [ Designated as safety issue: Yes ]

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).

• Other: Observation
  Patients will be observed after surgery until recurrence when they will be offered radiation therapy
  Other Name: Surgery Alone
• Radiation: Radiation Therapy
  Patients randomised to the Investigational treatment arm, will receive adjuvant curative post-operative radiation therapy aiming to reduce the rate of local recurrence. The recommended dose prescribed is 48 Gy in 20 fractions over 4 weeks.
  Other Name: RT, radiotherapy

• Active Comparator: Radiation Therapy
  Investigational Treatment
  Intervention: Radiation: Radiation Therapy
• No Intervention: Initial Observation
  Initial Observation
  Intervention: Other: Observation

Inclusion Criteria:

• Aged 18 years or older
• Has provided written informed consent for participation in this trial
• Histologically confirmed neurotropic primary melanoma
• 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 with or without microscopic positive margins
• No previous surgery for melanoma (other than complete macroscopic resection as stated above)
• 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