Neurotropic Melanoma of the Head and Neck

NCT00975520 | Completed DMC

• 3 other identifiers: 01.092009/039ACTRN12610000478011
• Study Type: interventional
• Target: 50
• Locations: 3 countries
• Sites: 16

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 features of neurotropism. Uncontrolled studies suggest that this form of primary melanoma has a high risk of local recurrence and that postoperative radiation therapy may substantially reduce that risk. Patients who are eligible on the basis of the pathology of the excised melanoma will be offered the opportunity to take part in the trial. Those randomised to receive radiation therapy will be treated with a simple technique encompassing the surgical bed plus a margin. Radiation will commence within 3 months of surgery (maximum of 14 weeks from surgery to start of radiotherapy).

Conditions

Melanoma

Keywords

Neurotropic; Melanoma; Observation; Radiation Therapy; Relapse

Outcome Measures

Primary Outcomes (1)

• Time to local relapse

  5 years from the date of randomisation

Secondary Outcomes (6)

• Relapse free survival

  5 years from date of randomisation

• Time to Relapse

  5 years from date of randomisation

• Overall survival

  5 years from date of randomisation

• Cancer specific survival

  5 years from date of randomisation

• Patterns of relapse

  5 years from date of randomisation

Study Arms (2)

Radiation Therapy

ACTIVE COMPARATOR

Investigational Treatment

Radiation: Radiation Therapy

Observation

OTHER

Observation

Other: Observation

Interventions

Observation OTHER

Patients will be observed after surgery until recurrence when they will be offered radiation therapy

Also known as: Surgery Alone

Observation

Radiation Therapy RADIATION

Patients randomised to the Investigational treatment arm, will receive adjuvant curative post-operative radiation therapy aiming to reduce the rate of local recurrence. The recommended dose prescribed is 48 Gy in 20 fractions over 4 weeks.

Also known as: RT, radiotherapy

Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Melanoma and Skin Cancer Trials Limited: lead
• Trans Tasman Radiation Oncology Group: collaborator

Study Sites (16)

Memorial Sloan Ketttering

New York, New York, 10065, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Calvary Mater Hospital

Newcastle, New South Wales, 2310, Australia

Location

Melanoma Institute Australia / Royal Prince Alfred Hospital

North Sydney, New South Wales, 2060, Australia

Location

Westmead Hospital

Westmead, New South Wales, Australia

Location

Wollongong Hospital

Wollongong, New South Wales, Australia

Location

Royal Brisbane and Womens Hospital

Herston, Queensland, Australia

Location

Radiation Oncology Services - Mater Centre

South Brisbane, Queensland, 4101, Australia

Location

Radiation Oncology Queensland (ROQ)

Toowoomba, Queensland, Australia

Location

Townsville Cancer Centre

Townsville, Queensland, Australia

Location

Genesis Care: Tugun

Tugun, Queensland, 4224, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Peter MacCallum Cancer Centre

East Melbourne, Victoria, 8006, Australia

Location

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Norfolk and Norwich University Hosptial, NHS Foundation Trust

Norwich, NR4 7UY, United Kingdom

Location

Related Links

• Please visit this website for further trial specific information

MeSH Terms

Conditions

Melanoma; Recurrence

Interventions

Observation; Surgical Procedures, Operative; Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques; Therapeutics; Physical Phenomena

Study Officials

• Matthew Foote

  Princess Alexandra Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2009
• First Posted: September 11, 2009
• Study Start: September 1, 2009
• Primary Completion: January 1, 2021
• Study Completion: March 1, 2023
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); GB (1); AU (13)