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Neurotropic Melanoma of the Head and Neck (RTN2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00975520
Recruitment Status : Active, not recruiting
First Posted : September 11, 2009
Last Update Posted : March 18, 2020
Sponsor:
Collaborator:
Trans-Tasman Radiation Oncology Group (TROG)
Information provided by (Responsible Party):
Melanoma and Skin Cancer Trials Limited

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).

Condition or disease Intervention/treatment Phase
Melanoma Other: Observation Radiation: Radiation Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Trial of Post-operative Radiation Therapy Following Wide Excision of Neurotropic Melanoma of the Head and Neck
Study Start Date : September 2009
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Active Comparator: Radiation Therapy
Investigational Treatment
Radiation: Radiation Therapy
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.
Other Name: RT, radiotherapy

Observation
Observation
Other: Observation
Patients will be observed after surgery until recurrence when they will be offered radiation therapy
Other Name: Surgery Alone




Primary Outcome Measures :
  1. Time to local relapse [ Time Frame: 5 years from the date of randomisation ]

Secondary Outcome Measures :
  1. Relapse free survival [ Time Frame: 5 years from date of randomisation ]
  2. Time to Relapse [ Time Frame: 5 years from date of randomisation ]
  3. Overall survival [ Time Frame: 5 years from date of randomisation ]
  4. Cancer specific survival [ Time Frame: 5 years from date of randomisation ]
  5. Patterns of relapse [ Time Frame: 5 years from date of randomisation ]
  6. Late Toxicity [ Time Frame: 5 years from date of randomisation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00975520


Locations
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United States, New York
Memorial Sloan Ketttering
New York, New York, United States, 10065
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Australia, New South Wales
Calvary Mater Hospital
Newcastle, New South Wales, Australia, 2310
Melanoma Institute Australia / Royal Prince Alfred Hospital
North Sydney, New South Wales, Australia, 2060
Westmead Hospital
Westmead, New South Wales, Australia
Wollongong Hospital
Wollongong, New South Wales, Australia
Australia, Queensland
Royal Brisbane and Womens Hospital
Herston, Queensland, Australia
Radiation Oncology Services - Mater Centre
South Brisbane, Queensland, Australia, 4101
Radiation Oncology Queensland (ROQ)
Toowoomba, Queensland, Australia
Townsville Cancer Centre
Townsville, Queensland, Australia
Genesis Care: Tugan
Tugan, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia, 8006
Alfred Hospital
Melbourne, Victoria, Australia, 3004
United Kingdom
Norfolk and Norwich University Hosptial, NHS Foundation Trust
Norwich, United Kingdom, NR4 7UY
Sponsors and Collaborators
Melanoma and Skin Cancer Trials Limited
Trans-Tasman Radiation Oncology Group (TROG)
Investigators
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Study Chair: Matthew Foote, Oncologist Princess Alexandra Hospital
Additional Information:
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Responsible Party: Melanoma and Skin Cancer Trials Limited
ClinicalTrials.gov Identifier: NCT00975520    
Other Study ID Numbers: 01.09
2009/039 ( Other Identifier: HREC )
ACTRN12610000478011 ( Registry Identifier: ANZCTR )
First Posted: September 11, 2009    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not sharing IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Melanoma and Skin Cancer Trials Limited:
Neurotropic
Melanoma
Observation
Radiation Therapy
Relapse
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas