A randomised trial to evaluate the effect of postoperative radiation therapy following wide excision of neurotropic melanoma of the head and neck on time to local relapse (RTN2 Study)

Melanoma and Skin Cancer (MASC) Trials0 个研究点目标入组 50 人开始时间: 2010年6月10日最近更新: 2024年1月8日

适应症

试验速览

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•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

•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.

发起方

Melanoma and Skin Cancer (MASC) Trials