None listed
Conditions
Brief summary
This study looks at the effectiveness of the addition of radiotherapy to surgery on local relapse and survival in patients with neurotropic melanoma. Who is it for? You can join this study if you have neurotropic primary melanoma in the head or neck, and have had no previous surgery and you will be treated at Princess Alexandra Hospital in Queensland (Other sites around Australia will be opened within the next six months). Trial details Participants will be in two groups. Both groups will receive surgery to excise their melanomas, and then one group will be randomised to receive follow-up post-operative radiation therapy. The other group will be randomised to observation only after their surgery, with follow-up occurring every 3 months for the first 2 years, then every 6 months for the next 3 years. The aim of the study is to compare the local relapse rate, survival, side effects and quality of life between the two groups.
Interventions
Surgical excision of melanoma - this will occur before patient is recruited to trial.
Radiation - Patients randomised to the Investigational treatment arm, will receive adjuvant curative post-operative radiation therapy aiming to reduce the rate of local relapse. This will be at a dose of 48Gy in 20 fractions.
Observation of affected area will be once every 3 months for the first 2 years, then every 6 months for the next 3 years.
Follow up frequency and overall duration for the observational a
Surgical excision of melanoma - this will occur before patient is recruited to trial. Radiation - Patients randomised to the Investigational treatment arm, will receive adjuvant curative post-operative radiation therapy aiming to reduce the rate of local relapse. This will be at a dose of 48Gy in 20 fractions. Observation of affected area will be once every 3 months for the first 2 years, then every 6 months for the next 3 years. Follow up frequency and overall duration for the observational arm is the same as for the radiation arm ie once every 3 motnhs for the first 2 years and then every 6 months for the next 3 years
Sponsors
Trans Tasman Radiation Oncology Group (TROG)
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
- 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 negative microscopic 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, and any form of imaging - 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 any form of imaging 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 greater than or equal to 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 greater than or equal to 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
Outcome results
None listed