Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-25 @ 4:29 AM
NCT ID:
NCT00975520
Eligibility Criteria:
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 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00975520
Study Brief:
Protocol Section:
NCT00975520