CompletedNot Applicable

Neurotropic Melanoma of the Head and Neck

United States, Australia, United Kingdom50 participantsStarted 2009-09

Plain-language summary

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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time to local relapse

Timeframe: 5 years from the date of randomisation

Trial details

NCT IDNCT00975520

SponsorMelanoma and Skin Cancer Trials Limited

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-01

View on ClinicalTrials.gov More Melanoma trials