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Trial registered on ANZCTR


Registration number
ACTRN12610000478011
Ethics application status
Approved
Date submitted
3/12/2009
Date registered
10/06/2010
Date last updated
21/08/2020
Date data sharing statement initially provided
12/02/2019
Date results information initially provided
21/08/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of postoperative radiation therapy on time to local relapse in patients with neurotropic melanoma of the head and neck.
Scientific title
A randomised trial to evaluate the effect of postoperative radiation therapy following wide excision of neurotropic melanoma of the head and neck on time to local relapse (RTN2 Study)
Secondary ID [1] 1167 0
Clinicaltrials.gov ID NCT00975520
Secondary ID [2] 251994 0
MASC 01.09
Universal Trial Number (UTN)
Trial acronym
RTN2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neurotropic Melanoma 252335 0
Condition category
Condition code
Cancer 252523 252523 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm A: Initial Radiation Therapy. Treatment: Other - Radiation Therapy. Patients are randomised to receive initial Radiation Therapy following surgery. Radiation therapy must begin within 14 weeks of surgery. 48Gy is delivered in 20 fractions over 4 weeks.
Intervention code [1] 255642 0
Treatment: Other
Intervention code [2] 255643 0
Other interventions
Comparator / control treatment
Arm B: Initial Observation. Other Intervention - Observation. Patients randomised to initial observation following surgery. If local failure (defined as relapse of disease at any time following randomisation) occurs , patients will receive radiation therapy of 48Gy in 20 fractions over 4 weeks.
Control group
Active

Outcomes
Primary outcome [1] 253406 0
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.
Timepoint [1] 253406 0
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.
Secondary outcome [1] 262501 0
Relapse free survival. Measured from date of randomisation to the development of relapse at any site (inclduing regional and distant metastasis). Relapse should be confirmed through biopsy, imaging or photographs as defined in the protocol.
Timepoint [1] 262501 0
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.
Secondary outcome [2] 262502 0
Time to relapse. Measured from date of randomisation to the development of relapse at any site (inclduing regional and distant metastasis). Relapse should be confirmed through biopsy, imaging or photographs as defined in the protocol.
Timepoint [2] 262502 0
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.
Secondary outcome [3] 262503 0
Overall Survival. Measured from date of registration until death from any cause. Clinical assessment and follow-up.
Timepoint [3] 262503 0
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.
Secondary outcome [4] 262504 0
Cancer Specific Survival. Measured from date of registration until death from melanoma. Patients will be clinically assessed throughout the trial
Timepoint [4] 262504 0
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.
Secondary outcome [5] 262505 0
Patterns of Relapse. Measured as the exact site (local, regional or distant) and timing of each relapse. Relapse should be confirmed through biopsy, imaging or photographs, where possile, as defined in the protocol.
Timepoint [5] 262505 0
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.
Secondary outcome [6] 262506 0
Late Toxicity. Measred using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTC AE) v 4.0.
Timepoint [6] 262506 0
Within 5 years from date of randomisation, measured every 3 months for 2 years post radiotherapy (RT), then every 6 months for 3 years.
Secondary outcome [7] 262507 0
Quality of Life. Measured by the European Organisation for Research and Treatment of Cancer Quality of Lofe Questionnaire(EORTC QLQ-C30) questionnaire.
Timepoint [7] 262507 0
At baseline, 14 weeks post surgery, then every 6 months until 5 year follow-up is complete.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients are registered on trial by implementing the registration and eligibility case report forms (CRFs) and forwarding by fax to the Trial Coordinating Centre.
Prior to patient enrolment, the investigator should ensure that all of the following
requirements are met:
· The patient meets all inclusion criteria and none of the exclusion criteria should
apply.
· The patient and investigator have signed and dated all applicable consent forms.
· All baseline assessments and investigations have been performed.
· The eligibility checklist has been completed, signed and dated.

The randomisation will be performed from
the Trial Coordinating Centre with all trial staff blinded to the codes, and with the codes maintained in a locked secure environment. The randomisation process itself will be nonblinded to the trial staff involved.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible patients will be randomised in the ratio of 1:1 between the two arms, initial radiation therapy and initial observation. Allocation to treatment will be balanced by institution and site (head or neck) using the minimisation technique.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 1374 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 1375 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [3] 1376 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [4] 1377 0
The Townsville Hospital - Douglas
Recruitment hospital [5] 1378 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [6] 1379 0
Westmead Hospital - Westmead
Recruitment hospital [7] 1380 0
Nepean Hospital - Kingswood
Recruitment hospital [8] 1381 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment hospital [9] 1382 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [10] 6234 0
The Poche Centre, Melanoma Institute Australia - North Sydney
Recruitment hospital [11] 6235 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [12] 7505 0
The Alfred - Prahran
Recruitment hospital [13] 7506 0
Wollongong Hospital - Wollongong
Recruitment hospital [14] 7507 0
Genesis Cancer Care - Tugun - Tugun
Recruitment hospital [15] 7508 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [16] 13092 0
Genesis Cancer Care - Southport - Southport
Recruitment hospital [17] 13093 0
Genesis Cancer Care - Wesley - Auchenflower
Recruitment hospital [18] 13094 0
Genesis Cancer Care - Chermside - Chermside
Recruitment postcode(s) [1] 13654 0
4101 - South Brisbane
Recruitment postcode(s) [2] 13655 0
4350 - Toowoomba
Recruitment postcode(s) [3] 13656 0
4224 - Tugun
Recruitment postcode(s) [4] 15331 0
3004 - Prahran
Recruitment postcode(s) [5] 15332 0
2500 - Wollongong
Recruitment postcode(s) [6] 25602 0
4215 - Southport
Recruitment postcode(s) [7] 25603 0
4066 - Auchenflower
Recruitment postcode(s) [8] 25604 0
4032 - Chermside
Recruitment outside Australia
Country [1] 8672 0
United States of America
State/province [1] 8672 0
New York, Texas
Country [2] 8673 0
United Kingdom
State/province [2] 8673 0
Norfolk and Norwich University Hospital, Nottingham University Hospital and Sheffield Teaching Hospital
Country [3] 21277 0
Slovenia
State/province [3] 21277 0
Institute of Oncology Ljubljana

Funding & Sponsors
Funding source category [1] 256123 0
Other Collaborative groups
Name [1] 256123 0
Trans Tasman Radiation Oncology Group (TROG)
Address [1] 256123 0
Central Operations Office
Calvary Mater Newcastle
Locked Bag 7 HRMC
NSW 2310
Australia
Country [1] 256123 0
Australia
Funding source category [2] 256124 0
Hospital
Name [2] 256124 0
Princess Alexandra Hospital
Address [2] 256124 0
Ipswich Road
Woolloongabba
QLD 4102
Country [2] 256124 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Melanoma and Skin Cancer (MASC) Trials
Address
The Poche Centre
40 Rocklands Rd
North Sydney NSW 2060
Country
Australia
Secondary sponsor category [1] 251466 0
Individual
Name [1] 251466 0
Professor Bryan Burmiester
Address [1] 251466 0
Princess Alexandra Hospital
Level 2
Ipswich Road
Woolloongabba
QLD 4102
Country [1] 251466 0
Australia
Other collaborator category [1] 987 0
Other Collaborative groups
Name [1] 987 0
Trans Tasman Radiation Oncology Group (TROG)
Address [1] 987 0
Central Operations Office
Calvary Mater Hospital
Locked Bag 7
HRMC NSW 2310
Country [1] 987 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258215 0
Princess Alexandra Hospital Human Research Ethics Committee
Ethics committee address [1] 258215 0
Princess Alexandra Hospital
Level 2, Building 35 (TAFE 3)
Ipswich Road
Woolloongabba Qld 4102
Ethics committee country [1] 258215 0
Australia
Date submitted for ethics approval [1] 258215 0
Approval date [1] 258215 0
03/03/2009
Ethics approval number [1] 258215 0
2009/039 03/03/09

Summary
Brief summary
This study is comparing surgery alone with surgery plus post-operative radiation therapy for patients with completely resected primary melanoma showing histological features of neurotropism.

Who is it for?
You may be eligible to join this study if you aged 18 years or above and have been diagnosed with neurotropic primary melanoma in the head/neck area.

Study details
Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will undergo radiation therapy over 4 weeks, commencing within 3 months of surgery. Participants in the other group will undergo surgery followed by observation only.

Participants will be monitored for up to 5 years in order to evaluate treatment effect, survival rates, and quality of life.
Trial website
https://www.masc.org.au/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30575 0
A/Prof Matthew Foote
Address 30575 0
Princess Alexandra Hospital
Level 2
Ipswitch rd
Woolloongabba Qld
4102
Country 30575 0
Australia
Phone 30575 0
+61 7 3176 3067
Fax 30575 0
Email 30575 0
Matthew.Foote@health.qld.gov.au
Contact person for public queries
Name 13822 0
Ms Narelle Williams
Address 13822 0
The Poche Centre
40 Rocklands Rd
North Sydney NSW 2060
Country 13822 0
Australia
Phone 13822 0
+61 2 99117322
Fax 13822 0
+61 2 99549435
Email 13822 0
rtn2@masc.org.au
Contact person for scientific queries
Name 4750 0
Ms Yasmin Chu
Address 4750 0
The Poche Centre
40 Rocklands Rd
North Sydney NSW 2060
Country 4750 0
Australia
Phone 4750 0
+61 2 99117322
Fax 4750 0
+61 2 99549435
Email 4750 0
yasmin.chu@melanoma.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD will not be shared. Identifiable IPD is not collected.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary