Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18 - 75
Clinical summary
Summary
Melanoma is the third most common cancer in Australia. Approx 1000 Australians die of the disease each year. Neurotropism, defined as invasion by melanoma of peripheral neural tissue, is uncommon but it is this feature which is linked with a high risk of the cancer coming back in the same area. The primary aim of this trial is to determine if there is a difference in the rate of relapse between 2 randomised groups of patients treated after surgery with either radiation therapy or initial observation
Conditions
This trial is treating people with Melanoma
Eligibility
Inclusion
- 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
- 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
Inclusion
- Your cancer has not spread to other parts of the body (localised).
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR, ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Trans Tasman Radiation Oncology Group (TROG)
Scientific Title
A Randomised Trial of Post-operative Radiation Therapy Following Wide Excision of Neurotropic Melanoma of the Head and Neck (Other IDs: TROG 08.09, 2009/039, ANZMTG 01.09)
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