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

Phase 3
18 Years
Open (Enrolling)
Neurotropic Melanoma of the Head and Neck

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Trial Information

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

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to local relapse

Outcome Time Frame:

5 years from the date of randomisation

Safety Issue:


Principal Investigator

Bryan Burmeister

Investigator Role:

Study Chair

Investigator Affiliation:

Trans-Tasman Radiation Oncology Group (TROG)


Australia: Human Research Ethics Committee

Study ID:

TROG 08.09



Start Date:

September 2009

Completion Date:

September 2018

Related Keywords:

  • Neurotropic Melanoma of the Head and Neck
  • Neurotropic
  • Melanoma
  • Observation
  • Radiation Therapy
  • Relapse
  • Melanoma