Status:
COMPLETED
Neurotropic Melanoma of the Head and Neck
Lead Sponsor:
Melanoma and Skin Cancer Trials Limited
Collaborating Sponsors:
Trans Tasman Radiation Oncology Group
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 fea...
Detailed Description
Background Melanoma is a serious and common malignancy in Australia. It is the third most common cancer in Australia and approximately 1000 Australians will die of the disease each year.At least a qua...
Eligibility Criteria
Inclusion
- 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
- 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 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00975520
Start Date
September 1 2009
End Date
March 1 2023
Last Update
November 27 2024
Active Locations (16)
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1
Memorial Sloan Ketttering
New York, New York, United States, 10065
2
MD Anderson Cancer Center
Houston, Texas, United States, 77030
3
Calvary Mater Hospital
Newcastle, New South Wales, Australia, 2310
4
Melanoma Institute Australia / Royal Prince Alfred Hospital
North Sydney, New South Wales, Australia, 2060