Melanoma is a serious and common malignancy in Australia. It is the third most common cancer in Australia and approximately 1000 Australians will die of the disease each year. Neurotropism is an uncommon feature of melanoma and can be defined as invasion by melanoma of peripheral neural tissue, it also has a high risk of recurrence.Treatment of this type of melanoma has traditionally been surgery, however in some cases, the cancer is in a location where surgery alone is not effective in ensuring that all of the cancer cells have been removed. This trial will look at the addition of radiation therapy and its impact on reducing the risk of the cancer coming back compared to surgery to remove the cancer alone.

Official Title

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

Conditions

  • Neurotropic melanoma of the head and neck

Study Type

Interventional

Study Design

Treatment, Randomised, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary outcome measures

  • Time to local relapse
    [ Time Frame: Time from randomisation to time of diagnosis of local relapse ]
    [ Designated as safety issue: No ]

Secondary outcome measures

  • 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 ]

Study Start

September 09 – Sept 2018

Eligibility & Criteria

  • Ages eligible for study: 18 years and older
  • Genders eligible for study: Both
  • Accepts healthy volunteers: No

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.

Total Enrolment

100

Contact Details

Professor Bryan Burmeister
+61 07 3240 6581
Bryan_Burmeister@health.qld.gov.au