The effect of postoperative radiation therapy on time to local relapse in patients with neurotropic melanoma of the head and neck.

Phase 3

Completed

• Conditions: eurotropic Melanoma; Neurotropic Melanoma; Cancer - Malignant melanoma

• Registration Number: ACTRN12610000478011
• Lead Sponsor: Melanoma and Skin Cancer (MASC) Trials

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-10
• Study Completion: 2022-11-22
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to Local relapse. Measured from date of randomisation to time of diagnosis of local relapse. Relapse should be confirmed through biopsy, imaging or photographs as defined in the protocol.[ Within 5 years from date of randomisation. From baseline, first day of radiotherapy, weekly during radiotherapy, 14 weeks post surgery, then every 3 months for two years and every 6 months until 5 years follow up has been reached.]