Neurotropic Melanoma of the Head and Neck (RTN2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Trans-Tasman Radiation Oncology Group (TROG)
Sponsor:
Collaborator:
Australia and New Zealand Melanoma Trials Group
Information provided by (Responsible Party):
Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier:
NCT00975520
First received: September 10, 2009
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Neurotropic Melanoma of the Head and Neck
Other: Observation
Radiation: Radiation Therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised Trial of Post-operative Radiation Therapy Following Wide Excision of Neurotropic Melanoma of the Head and Neck

Resource links provided by NLM:


Further study details as provided by Trans-Tasman Radiation Oncology Group (TROG):

Primary Outcome Measures:
  • Time to local relapse [ Time Frame: 5 years from the date of randomisation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relapse free survival [ Time Frame: 5 years from date of randomisation ] [ Designated as safety issue: No ]
  • Time to Relapse [ Time Frame: 5 years from date of randomisation ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 5 years from date of randomisation ] [ Designated as safety issue: No ]
  • Cancer specific survival [ Time Frame: 5 years from date of randomisation ] [ Designated as safety issue: No ]
  • Patterns of relapse [ Time Frame: 5 years from date of randomisation ] [ Designated as safety issue: No ]
  • Late Toxicity [ Time Frame: 5 years from date of randomisation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: September 2009
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00975520

Contacts
Contact: Dr Matthew Foote +61 07 3240 2111 Matthew_Foote@health.qld.gov.au
Contact: Janelle Meakin +61 07 3240 2498 ext 2498 Janelle_Meakin@health.qld.gov.au

Locations
United States, New York
Memorial Sloan Ketttering Not yet recruiting
New York, New York, United States
Principal Investigator: Chris Baker         
Australia, New South Wales
Royal Prince Alfred Hospital Not yet recruiting
Camperdown, New South Wales, Australia, 2050
Calvary Mater Newcastle Recruiting
Newcastle, New South Wales, Australia
Principal Investigator: Mahesh Kumar         
Melanoma Institute Australia Recruiting
North Sydney, New South Wales, Australia
Principal Investigator: Angela Hong         
Westmead Recruiting
Westmead, New South Wales, Australia
Principal Investigator: Tim Wang         
Australia, Queensland
Royal Brisbane and Womens Hospital Recruiting
Herston, Queensland, Australia
Principal Investigator: Charles Lin         
Radiation Oncology Services Mater Centre Recruiting
South Brisbane, Queensland, Australia
Principal Investigator: Andrew Pullar         
Radiation Oncology Queensland (ROQ) Recruiting
Toowoomba, Queensland, Australia
Principal Investigator: Eric Khoo         
Townsville Cancer Centre Recruiting
Townsville, Queensland, Australia
Principal Investigator: Alex Tan         
Genesis Care: Tugan Recruiting
Tugan, Queensland, Australia
Principal Investigator: David Christie         
Princess Alexandra Hospital Recruiting
Woolloongabba, Queensland, Australia, 4102
Contact: Janelle Meakin    +61 07 3240 2498 ext 2498    Janelle_meakin@health.qld.gov.au   
Principal Investigator: Prof. Bryan Burmeister         
Australia, South Australia
Royal Adelaide Hospital Not yet recruiting
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Peter MacCallum Cancer Institute Not yet recruiting
Melbourne, Victoria, Australia, 3002
Sponsors and Collaborators
Trans-Tasman Radiation Oncology Group (TROG)
Australia and New Zealand Melanoma Trials Group
Investigators
Study Chair: Bryan Burmeister Trans-Tasman Radiation Oncology Group (TROG)
  More Information

Additional Information:
No publications provided

Responsible Party: Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier: NCT00975520     History of Changes
Other Study ID Numbers: TROG 08.09, 2009/039, ACTRN12610000478011
Study First Received: September 10, 2009
Last Updated: July 31, 2014
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Trans-Tasman Radiation Oncology Group (TROG):
Neurotropic
Melanoma
Observation
Radiation Therapy
Relapse

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on October 29, 2014