None listed
Conditions
Brief summary
This study is comparing surgery alone with surgery plus post-operative radiation therapy for patients with completely resected primary melanoma showing histological features of neurotropism. Who is it for? You may be eligible to join this study if you aged 18 years or above and have been diagnosed with neurotropic primary melanoma in the head/neck area. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will undergo radiation therapy over 4 weeks, commencing within 3 months of surgery. Participants in the other group will undergo surgery followed by observation only. Participants will be monitored for up to 5 years in order to evaluate treatment effect, survival rates, and quality of life.
Interventions
Arm A: Initial Radiation Therapy. Treatment: Other - Radiation Therapy. Patients are randomised to receive initial Radiation Therapy following surgery. Radiation therapy must begin within 14 weeks of surgery. 48Gy is delivered in 20 fractions over 4 weeks.
Sponsors
Melanoma and Skin Cancer (MASC) Trials
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients may be included in the trial only if they meet all of the following criteria: 1. Aged 18 years or older 2. Has provided written informed consent for participation in this trial 3. Histologically confirmed neurotropic primary melanoma 4. Tumour located above the clavicle and below the jaw or occiput (neck primary) or above the jaw/occiput (head primary) 5. Complete macroscopic resection of all known disease with or without microscopic positive margins 6. No previous surgery for melanoma (other than complete macroscopic resection as stated above) 7. No evidence of in-transit, nodal or distant metastases as determined by clinical examination, and any form of imaging. 8. Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less 9. Life expectancy greater than 6 months 10. Patients capable of childbearing are using adequate contraception 11. Available for follow up
Exclusion criteria
Patients who fulfil any of the following criteria are not eligible for admission to trial: 1. Women who are pregnant or lactating. 2. Intercurrent illness that will interfere with the radiation therapy such as immunosuppression due to medication or medical condition. 3. Clinical and/or MRI evidence of a named cranial or cervical nerve involvement by tumour 3. Inability to localise surgical bed on any form of imaging and/or surgical margins (cm) not known 5. Previous radical radiation therapy to the head and neck, excluding superficial radiation therapy to cutaneous Squamous Cell Carcinoma (SCC) or basal cell carcinoma, which is not within or overlapping the tumour bed. 6. High risk for poor compliance with therapy or follow-up as assessed by investigator 7. Patients with prior cancers, except: those diagnosed > or = 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 > or = 2 years ago; or non-melanoma skin cancer; or carcinoma in situ of the cervix. 7. Albinism. 8. Participation in other clinical trials with the same primary endpoint.
Outcome results
None listed