ANZMTG 01.09/TROG 08.09 - The RTN2 Study
Research type
Research Study
Full title
A Randomised Trial of Post Operative Radiation Therapy Following Wide Excision of Neurotropic Melanoma of the Head and Neck TROG 08.09 ANZMTG 01.09
IRAS ID
189168
Contact name
Elizabeth Paton
Contact email
Sponsor organisation
Australia and New Zealand Melanoma Trials Group
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
ACTRN12610000478011, Australia and New Zealand Clinical Trials Registry
Duration of Study in the UK
2 years, 2 months, 30 days
Research summary
This study involves patients diagnosed with an unusual form of melanoma known as neurotropic melanoma. When this type of melanoma is diagnosed on the head or neck, the traditional treatment is surgery. This disease may have a high rate of local recurrence after surgery. If so, having radiation therapy soon after surgery could reduce the risk of the melanoma from returning but there have been no randomised trials to study this. Therefore, the purpose of this trial is to investigate if having radiation therapy soon after surgery on the head and neck is better at preventing the melanoma returning than just having surgery alone.nitial post-operative radiation therapy compared to initial observation after surgery for neurotropic melanoma. The main purpose of this study is to compare the rates of local recurrence in each arm of the trial. A total of 100 patients will be recruited across Australia, New Zealand and in other countries. The study involves half of the participants (‘Arm A’) having a 4 week course of radiation to the area of surgery. The other half of the participants (‘Arm B’) will have ongoing assessments (‘observation’) and can receive radiation if the melanoma returns (‘recurrence’).
Patients randomised to receive radiation (‘Arm A’) treatment needs to commence within 3 months of the operation or when healing has occurred. They will usually need to visit the radiation department 5 days a week (not on weekends) for 20 treatments in total.
To participate in this study patients will need to be available to see your doctor regularly for at least 5 years (every 3 months for the first 2 years, then 6 monthly) to check for any signs of melanoma return and to monitor any long term side effects experienced.REC name
East of England - Essex Research Ethics Committee
REC reference
16/EE/0124
Date of REC Opinion
3 Oct 2016
REC opinion
Further Information Favourable Opinion