A Randomised Trial of Post-operative Radiation Therapy Following Wide Excision of Neurotropic Melanoma of the Head and Neck
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