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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
10/12/2023
Date data sharing statement initially provided
12/02/2019
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.
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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)
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Secondary ID [1]
1167
0
Clinicaltrials.gov ID NCT00975520
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Secondary ID [2]
251994
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MASC 01.09
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Universal Trial Number (UTN)
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Trial acronym
RTN2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neurotropic Melanoma
252335
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Condition category
Condition code
Cancer
252523
252523
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0
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Malignant melanoma
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
255642
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Treatment: Other
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Intervention code [2]
255643
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Other interventions
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
253406
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Timepoint [1]
253406
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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.
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Secondary outcome [1]
262501
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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.
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Assessment method [1]
262501
0
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Timepoint [1]
262501
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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.
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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.
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Assessment method [2]
262502
0
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Timepoint [2]
262502
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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.
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Secondary outcome [3]
262503
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Overall Survival. Measured from date of registration until death from any cause. Clinical assessment and follow-up.
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Assessment method [3]
262503
0
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Timepoint [3]
262503
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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.
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Secondary outcome [4]
262504
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Cancer Specific Survival. Measured from date of registration until death from melanoma. Patients will be clinically assessed throughout the trial
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Assessment method [4]
262504
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Timepoint [4]
262504
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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.
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Secondary outcome [5]
262505
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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.
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Assessment method [5]
262505
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Timepoint [5]
262505
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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.
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Secondary outcome [6]
262506
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Late Toxicity. Measred using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTC AE) v 4.0.
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Assessment method [6]
262506
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Timepoint [6]
262506
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Within 5 years from date of randomisation, measured every 3 months for 2 years post radiotherapy (RT), then every 6 months for 3 years.
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Secondary outcome [7]
262507
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Quality of Life. Measured by the European Organisation for Research and Treatment of Cancer Quality of Lofe Questionnaire(EORTC QLQ-C30) questionnaire.
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Assessment method [7]
262507
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Timepoint [7]
262507
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At baseline, 14 weeks post surgery, then every 6 months until 5 year follow-up is complete.
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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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.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
11/09/2009
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Actual
11/09/2009
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Date of last participant enrolment
Anticipated
27/05/2020
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Actual
31/01/2020
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Date of last data collection
Anticipated
31/01/2025
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Actual
22/11/2022
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Sample size
Target
50
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Accrual to date
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Final
50
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
1374
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [2]
1375
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Mater Adult Hospital - South Brisbane
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Recruitment hospital [3]
1376
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Royal Brisbane & Womens Hospital - Herston
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Recruitment hospital [4]
1377
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The Townsville Hospital - Douglas
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Recruitment hospital [5]
1378
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Calvary Mater Newcastle - Waratah
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Recruitment hospital [6]
1379
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Westmead Hospital - Westmead
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Recruitment hospital [7]
1380
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Nepean Hospital - Kingswood
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Recruitment hospital [8]
1381
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Peter MacCallum Cancer Institute - East Melbourne
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Recruitment hospital [9]
1382
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The Royal Adelaide Hospital - Adelaide
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Recruitment hospital [10]
6234
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The Poche Centre, Melanoma Institute Australia - North Sydney
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Recruitment hospital [11]
6235
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [12]
7505
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The Alfred - Prahran
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Recruitment hospital [13]
7506
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Wollongong Hospital - Wollongong
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Recruitment hospital [14]
7507
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Genesis Cancer Care - Tugun - Tugun
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Recruitment hospital [15]
7508
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Toowoomba Hospital - Toowoomba
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Recruitment hospital [16]
13092
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Genesis Cancer Care - Southport - Southport
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Recruitment hospital [17]
13093
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Genesis Cancer Care - Wesley - Auchenflower
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Recruitment hospital [18]
13094
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Genesis Cancer Care - Chermside - Chermside
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Recruitment postcode(s) [1]
15332
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2500 - Wollongong
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Recruitment postcode(s) [2]
15331
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3004 - Prahran
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Recruitment postcode(s) [3]
25604
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4032 - Chermside
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Recruitment postcode(s) [4]
25603
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4066 - Auchenflower
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Recruitment postcode(s) [5]
13654
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4101 - South Brisbane
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Recruitment postcode(s) [6]
25602
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4215 - Southport
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Recruitment postcode(s) [7]
13656
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4224 - Tugun
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Recruitment postcode(s) [8]
13655
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4350 - Toowoomba
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Recruitment outside Australia
Country [1]
8672
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United States of America
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State/province [1]
8672
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New York, Texas
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Country [2]
8673
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United Kingdom
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State/province [2]
8673
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Norfolk and Norwich University Hospital, Nottingham University Hospital and Sheffield Teaching Hospital
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Country [3]
21277
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Slovenia
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State/province [3]
21277
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Institute of Oncology Ljubljana
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Funding & Sponsors
Funding source category [1]
256123
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Other Collaborative groups
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Name [1]
256123
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Trans Tasman Radiation Oncology Group (TROG)
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Address [1]
256123
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Central Operations Office
Calvary Mater Newcastle
Locked Bag 7 HRMC
NSW 2310
Australia
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Country [1]
256123
0
Australia
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Funding source category [2]
256124
0
Hospital
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Name [2]
256124
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Princess Alexandra Hospital
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Address [2]
256124
0
Ipswich Road
Woolloongabba
QLD 4102
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Country [2]
256124
0
Australia
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Primary sponsor type
Other Collaborative groups
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Name
Melanoma and Skin Cancer (MASC) Trials
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Address
553 St Kilda Road
Melbourne, Victoria 3004
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Country
Australia
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Secondary sponsor category [1]
251466
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Individual
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Name [1]
251466
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Professor Bryan Burmiester
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Address [1]
251466
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Princess Alexandra Hospital
Level 2
Ipswich Road
Woolloongabba
QLD 4102
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Country [1]
251466
0
Australia
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Other collaborator category [1]
987
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Other Collaborative groups
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Name [1]
987
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Trans Tasman Radiation Oncology Group (TROG)
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Address [1]
987
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Central Operations Office
Calvary Mater Hospital
Locked Bag 7
HRMC NSW 2310
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Country [1]
987
0
Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
258215
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Princess Alexandra Hospital Human Research Ethics Committee
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Ethics committee address [1]
258215
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Princess Alexandra Hospital Level 2, Building 35 (TAFE 3) Ipswich Road Woolloongabba Qld 4102
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Ethics committee country [1]
258215
0
Australia
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Date submitted for ethics approval [1]
258215
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Approval date [1]
258215
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03/03/2009
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Ethics approval number [1]
258215
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2009/039 03/03/09
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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.
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Trial website
https://www.masc.org.au/
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Trial related presentations / publications
MB Pinkham, et. al. Results from a randomised trial of post-operative radiation therapy following wide excision of neurotropic melanoma of the head and neck (RTN2 trial 01.09). Australasian Melanoma Conference, 2023.
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Matthew Foote
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Address
30575
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Princess Alexandra Hospital
Level 2
Ipswitch rd
Woolloongabba Qld
4102
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Country
30575
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Australia
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Phone
30575
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+61 7 3176 3067
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Fax
30575
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Email
30575
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Matthew.Foote@health.qld.gov.au
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Contact person for public queries
Name
13822
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Simon Cumming
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Address
13822
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Melanoma and Skin Cancer Trials
553 St Kilda Road
Melbourne, Victoria 3004
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Country
13822
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Australia
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Phone
13822
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+61 3 9903 9022
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Fax
13822
0
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Email
13822
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rtn2@masc.org.au
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Contact person for scientific queries
Name
4750
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Simon Cumming
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Address
4750
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Melanoma and Skin Cancer Trials
553 St Kilda Road
Melbourne, Victoria 3004
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Country
4750
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Australia
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Phone
4750
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+61 3 9903 9022
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Fax
4750
0
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Email
4750
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rtn2@masc.org.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
IPD will not be shared. Identifiable IPD is not collected.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF