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DEFINITIONS
Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12607000063415
Ethics application status
Approved
Date submitted
23/12/2003
Date registered
23/12/2003
Date last updated
27/11/2015
Type of registration
Retrospectively registered
Titles & IDs
Public title
Immediate or delayed radiotherapy after surgery for melanoma involving lymph nodes
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Scientific title
Trans Tasman Radiation Oncology Group (TROG) 02.01 - A randomised clinical trial of surgery versus surgery plus adjuvant radiotherapy in patients with completely resected macroscopic nodal metastatic melanoma to improve regional relapse rates.
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Secondary ID [1]
50
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ClinicalTrials.gov: NCT00287196
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Secondary ID [2]
51
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National Clinical Trials Registry: NCTR487
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Universal Trial Number (UTN)
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Trial acronym
TROG 02.01
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic melanoma
46
0
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Lymph node disease
47
0
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Condition category
Condition code
Cancer
53
53
0
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 1: Immediate Post-operative radiotherapy. 48 Gy reference dose in 20 fractions at 5 fractions per week, with a maximum overall treatment time of 30 days
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Intervention code [1]
1302
0
Treatment: Other
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Comparator / control treatment
ARM 2: Observation with delayed radiotherapy for relapse. Dose is at treating physician discretion.
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Control group
Active
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Outcomes
Primary outcome [1]
86
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Rate of regional relapse - Time to regional failure.
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Assessment method [1]
86
0
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Timepoint [1]
86
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Measured until death. Follow up visits are every 3 months from randomisation for the first 2 years, then every 6 months until 5 years and then annually.
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Secondary outcome [1]
169
0
Failure free survival
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Assessment method [1]
169
0
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Timepoint [1]
169
0
Measured from the date of randomisation to the date of a relapse in any site or death. Follow up visits are every 3 months from randomisation for the first 2 years, then every 6 months until 5 years and then annually.
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Secondary outcome [2]
170
0
Overall survival
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Assessment method [2]
170
0
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Timepoint [2]
170
0
Measured from date of randomisation to the date of death from any cause. Follow up visits are every 3 months from randomisation for the first 2 years, then every 6 months until 5 years and then annually.
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Secondary outcome [3]
171
0
Toxicity
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Assessment method [3]
171
0
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Timepoint [3]
171
0
2 and 6 weeks post radiotherapy, every 3 months from randomisation for first 2 years, then every 6 months until 5 years and then annually until relapse or death.
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Secondary outcome [4]
172
0
Quality of Life
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Assessment method [4]
172
0
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Timepoint [4]
172
0
Pre-randomisation and then every 3 months from randomisation for first 2 years, then every 6 months until 5 years and then annually until relapse or death.
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Eligibility
Key inclusion criteria
All of the following criteria must apply for the patient to be eligible for the trial:
1. Regional macroscopic (palpable) nodal metastatic melanoma in one nodal basin region only (either parotid/neck, axilla or groin) which has been completely resected.
Patients presenting according to any of the three following ways are eligible: node metastases (i) occurring concurrently with the initial diagnosis of primary melanoma, (ii) appearing subsequently after the successful treatment of the primary, or (iii) as a first presentation of melanoma with an unknown primary.
Patients who undergo two or more operations to achieve total standards specified for lymphadenectomy must complete them within 8 weeks. A previous biopsy (open or closed) where the operative intent was not a definitive curative procedure does not need to be included within this 8 week period. Patients who undergo a procedure that is not curative in intent (e.g. revision of wound edges) after a definitive procedure that is curative in intent (e.g. inguinal
lymphadenectomy) will need to have this procedure completed within 12 weeks following the final definitive procedure.
2. A completed Synoptic Pathology Report which states that:
(a) resection is complete
And
(b) the lymphadenectomy specimen contains the required minimum numbers of
harvested nodes in the involved sites, as follows:
Superficial parotidectomy 2
Neck dissection
Comprehensive (levels I-V) 25
Selective
4 levels (e.g. Sentinal Node Dissection (SND) (I-IV) or Sentinal Node Dissection (SND) (II-V, +/-postauricular/occipital) 20
3 levels (e.g. Sentinal Node Dissection (SND) (I-III) or Sentinal Node Dissection (SND) (III-V)
15
Axillary dissection 10
Superficial inguinal dissection (4 for deep inguinal/pelvic node dissection if
performed in conjunction with superficial inguinal dissection) 6
3. At significant risk of regional relapse, defined as at least one of the following being present (as per Synoptic Pathology Report):
a) the number of nodes involved is:
> 1 node for parotid, or
> 2 nodes for neck or axilla, or
> 3 nodes for groin.
or b) Extranodal tissue spread;
or c) Any one metastatic node of maximum diameter = 3 cm neck, or = 4 cm in axilla or groin.
4. All staging investigations have been completed: Computed Tomography (CT) of nodal basin, Computed Tomography of
chest/abdomen/pelvis and Computed Tomography of brain. (Brain Magnetic Resonance Imaging may be substituted for brain Computed Tomography for initial staging only.)
5. Serum Lactate Dehydrogenase (LDH) < 1.5 times the upper limit of normal.
6. World Health Organisation (WHO) performance status of 0 or 1.
7. Age 18 years or older.
8. Expected life span of two or more years in the absence of melanoma.
9. A photograph has been taken of the involved nodal basin region; the photograph is to include the recent lymphadenectomy scar(s) and the defined anatomic boundaries drawn on the skin
for the node basin region concerned (refer to section 8.2 for details).
10. Radiotherapy must be able to be commenced within 12 weeks of lymphadenectomy.
11. Patient must not be pregnant and if fertile must use a medically acceptable contraceptive throughout the treatment period.
12. Written informed consent has been given.
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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
None of the following criteria must apply for the patient to be eligible for the trial.
1. Evidence of active or previous local recurrence or in transit disease; or evidence of nodal metastases or regional disease beyond the lymphadenectomy bed.
2. Evidence of distant metastases on clinical or radiological investigation.
3. Patients with prior cancers, except: those diagnosed more than five years ago with no evidence of disease recurrence within this time and with clinical expectation of recurrence of less than 10 %; and successfully treated basal cell or squamous cell skin carcinoma; and carcinoma in situ of cervix; and multiple primary melanoma. However, any patient with previous invasive breast cancer or prostate cancer is excluded.
Note: Treatment with adjuvant systemic therapy does not exclude participation in the trial. However cytotoxic drugs, other than interferon, should not be delivered during, or in close association with, radiation treatment. Documentation of adjuvant systemic therapy will be required.
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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)
Central randomisation by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation. Factors: Institution, Nodal basin site (parotid or neck, axilla or groin), number of nodes involved depending on site, maximum node diameter (<=4, >4) and extent of extrandoal tissue spread (none, limited, extensive). Simple randomisation by computer.
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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
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
20/03/2002
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Actual
20/03/2002
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Date of last participant enrolment
Anticipated
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Actual
21/09/2007
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
250
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Accrual to date
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Final
250
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,WA,VIC
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Recruitment hospital [1]
4769
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Calvary Mater Newcastle - Waratah
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Recruitment hospital [2]
4770
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Mater Sydney - North Sydney
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Recruitment hospital [3]
4771
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Prince of Wales Hospital - Randwick
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Recruitment hospital [4]
4772
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [5]
4773
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Westmead Private Hospital - Westmead
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Recruitment hospital [6]
4774
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Mater Adult Hospital - South Brisbane
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Recruitment hospital [7]
4775
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The Royal Adelaide Hospital - Adelaide
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Recruitment hospital [8]
4776
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Launceston General Hospital - Launceston
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Recruitment hospital [9]
4777
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The Alfred - Prahran
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Recruitment hospital [10]
4778
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Peter MacCallum Cancer Institute - East Melbourne
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Recruitment hospital [11]
4779
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment hospital [12]
4780
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Royal Perth Hospital - Perth
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Recruitment outside Australia
Country [1]
387
0
New Zealand
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State/province [1]
387
0
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Country [2]
7385
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Netherlands
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State/province [2]
7385
0
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Country [3]
7386
0
Brazil
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State/province [3]
7386
0
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Funding & Sponsors
Funding source category [1]
75
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Government body
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Name [1]
75
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National Health & Medical Research Council
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Address [1]
75
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Level 5, 20 Allara St Canberra ACT 2601
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Country [1]
75
0
Australia
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Funding source category [2]
76
0
Government body
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Name [2]
76
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Anti-Cancer Council of South Australia
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Address [2]
76
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Level 5, 20 Allara St Canberra ACT 2601
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Country [2]
76
0
Australia
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Primary sponsor type
Individual
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Name
Bryan Burmeister
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Address
Princess Alexandra Hospital Oncology Services Ipswich Road Woolloongabba QLD 4102
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Country
Australia
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Secondary sponsor category [1]
63
0
Other Collaborative groups
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Name [1]
63
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Trans Tasman Radiation Oncology Group (TROG)
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Address [1]
63
0
Edith St Waratah NSW 2298
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Country [1]
63
0
Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
563
0
William Buckland Radiotherapy Centre, The Alfred
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Ethics committee address [1]
563
0
Prahran, VIC
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Ethics committee country [1]
563
0
Australia
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Date submitted for ethics approval [1]
563
0
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Approval date [1]
563
0
01/08/2002
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Ethics approval number [1]
563
0
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Ethics committee name [2]
564
0
Andrew Love Cancer Centre, Geelong Hospital
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Ethics committee address [2]
564
0
Geelong, VIC
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Ethics committee country [2]
564
0
Australia
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Date submitted for ethics approval [2]
564
0
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Approval date [2]
564
0
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Ethics approval number [2]
564
0
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Ethics committee name [3]
565
0
Auckland Hospital
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Ethics committee address [3]
565
0
Auckland, NZ
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Ethics committee country [3]
565
0
New Zealand
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Date submitted for ethics approval [3]
565
0
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Approval date [3]
565
0
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Ethics approval number [3]
565
0
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Ethics committee name [4]
566
0
Christchurch Hospital
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Ethics committee address [4]
566
0
Christchurch, NZ
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Ethics committee country [4]
566
0
New Zealand
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Date submitted for ethics approval [4]
566
0
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Approval date [4]
566
0
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Ethics approval number [4]
566
0
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Ethics committee name [5]
567
0
Dunedin Hospital
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Ethics committee address [5]
567
0
Dunedin, Otago, NZ
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Ethics committee country [5]
567
0
New Zealand
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Date submitted for ethics approval [5]
567
0
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Approval date [5]
567
0
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Ethics approval number [5]
567
0
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Ethics committee name [6]
568
0
Premion Tugun
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Ethics committee address [6]
568
0
Tugun, QLD
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Ethics committee country [6]
568
0
Australia
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Date submitted for ethics approval [6]
568
0
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Approval date [6]
568
0
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Ethics approval number [6]
568
0
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Ethics committee name [7]
569
0
Groningen University Hospital
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Ethics committee address [7]
569
0
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Ethics committee country [7]
569
0
Netherlands
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Date submitted for ethics approval [7]
569
0
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Approval date [7]
569
0
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Ethics approval number [7]
569
0
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Ethics committee name [8]
570
0
Launceston Hospital
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Ethics committee address [8]
570
0
Launceston, TAS
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Ethics committee country [8]
570
0
Australia
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Date submitted for ethics approval [8]
570
0
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Approval date [8]
570
0
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Ethics approval number [8]
570
0
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Ethics committee name [9]
571
0
Mater Hospital
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Ethics committee address [9]
571
0
North Sydney, NSW
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Ethics committee country [9]
571
0
Australia
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Date submitted for ethics approval [9]
571
0
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Approval date [9]
571
0
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Ethics approval number [9]
571
0
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Ethics committee name [10]
572
0
Calvary Mater Newcastle
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Ethics committee address [10]
572
0
Waratah, NSW
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Ethics committee country [10]
572
0
Australia
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Date submitted for ethics approval [10]
572
0
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Approval date [10]
572
0
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Ethics approval number [10]
572
0
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Ethics committee name [11]
573
0
Peter MacCallum Cancer Centre
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Ethics committee address [11]
573
0
Melbourne, VIC
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Ethics committee country [11]
573
0
Australia
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Date submitted for ethics approval [11]
573
0
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Approval date [11]
573
0
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Ethics approval number [11]
573
0
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Ethics committee name [12]
574
0
Princess Alexandra Hospital
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Ethics committee address [12]
574
0
Wooloongabba, QLD
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Ethics committee country [12]
574
0
Australia
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Date submitted for ethics approval [12]
574
0
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Approval date [12]
574
0
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Ethics approval number [12]
574
0
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Ethics committee name [13]
575
0
Prince of Wales Hospital
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Ethics committee address [13]
575
0
Randwick, NSW
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Ethics committee country [13]
575
0
Australia
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Date submitted for ethics approval [13]
575
0
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Approval date [13]
575
0
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Ethics approval number [13]
575
0
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Ethics committee name [14]
576
0
Mater Centre QRI
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Ethics committee address [14]
576
0
South Brisbane, QLD
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Ethics committee country [14]
576
0
Australia
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Date submitted for ethics approval [14]
576
0
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Approval date [14]
576
0
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Ethics approval number [14]
576
0
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Ethics committee name [15]
577
0
Royal Adelaide Hospital
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Ethics committee address [15]
577
0
Adelaide, SA
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Ethics committee country [15]
577
0
Australia
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Date submitted for ethics approval [15]
577
0
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Approval date [15]
577
0
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Ethics approval number [15]
577
0
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Ethics committee name [16]
578
0
Royal Brisbane and Women's Hospital
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Ethics committee address [16]
578
0
Herston, QLD
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Ethics committee country [16]
578
0
Australia
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Date submitted for ethics approval [16]
578
0
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Approval date [16]
578
0
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Ethics approval number [16]
578
0
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Ethics committee name [17]
579
0
Royal Perth Hospital
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Ethics committee address [17]
579
0
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Ethics committee country [17]
579
0
Australia
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Date submitted for ethics approval [17]
579
0
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Approval date [17]
579
0
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Ethics approval number [17]
579
0
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Ethics committee name [18]
580
0
Royal Prince Alfred Hospital
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Ethics committee address [18]
580
0
Perth, WA
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Ethics committee country [18]
580
0
Australia
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Date submitted for ethics approval [18]
580
0
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Approval date [18]
580
0
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Ethics approval number [18]
580
0
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Ethics committee name [19]
581
0
Royal Prince Alfred Hospital
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Ethics committee address [19]
581
0
Camperdown, NSW
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Ethics committee country [19]
581
0
Australia
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Date submitted for ethics approval [19]
581
0
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Approval date [19]
581
0
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Ethics approval number [19]
581
0
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Ethics committee name [20]
582
0
Wellington Hospital
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Ethics committee address [20]
582
0
Wellington, NZ
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Ethics committee country [20]
582
0
New Zealand
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Date submitted for ethics approval [20]
582
0
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Approval date [20]
582
0
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Ethics approval number [20]
582
0
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Ethics committee name [21]
583
0
Westmead Hospital
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Ethics committee address [21]
583
0
Wentworhville, NSW
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Ethics committee country [21]
583
0
Australia
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Date submitted for ethics approval [21]
583
0
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Approval date [21]
583
0
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Ethics approval number [21]
583
0
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Summary
Brief summary
Surgery is the standard treatment for melanoma that has spread to nearby lymph glands, but it sometimes recurs despite surgery. Radiotherapy given soon after surgery may redue the risk of the melanoma coming back, but mat also cause side effects. This national randomised trial will determine the benefits and side effects of adding radiotherpay after surgery.
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Trial website
www.trog.com.au
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Trial related presentations / publications
Burmeister BH, Henderson MA, Ainslie J, Fisher R, Di Iulio J, Smithers BM, Hong A, Kerwin S, Scolyer RA, Curruthjers S, Coventry BJ, Babington S, Duprat J, Hoekstra HJ, Thompson. Adjuvant radiotherapy improves regional lymph node field control in melanoma patients at high risk of relapse after therapeutic lymphadenectomy – results of a randomised intergroup trial. Lancet Oncol 2012, 13 (6): 589 – 597.
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Public notes
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Contacts
Principal investigator
Name
35232
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Prof Bryan Burmeister
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Address
35232
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Princess Alexandra Hospital Oncology Services Ipswich Road Woolloongabba QLD 4102
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Country
35232
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Australia
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Phone
35232
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+61 7 3240 6584
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Fax
35232
0
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Email
35232
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Bryan_Burmeister@health.qld.gov.au
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Contact person for public queries
Name
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Juliana Dilulio
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Address
10491
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Department of Radiation Oncology
Locked Bag 1
A'Beckett Street
VIC 8006
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Country
10491
0
Australia
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Phone
10491
0
+61 3 9656 3786
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Fax
10491
0
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Email
10491
0
Juliana.DiIulio@petermac.org
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Contact person for scientific queries
Name
1419
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Bryan Burmeister
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Address
1419
0
Princess Alexandra Hospital
Oncology Services
Ipswich Road
Woolloongabba QLD 4102
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Country
1419
0
Australia
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Phone
1419
0
+61 7 3240 6584
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Fax
1419
0
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Email
1419
0
Bryan_Burmeister@health.qld.gov.au
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No information has been provided regarding IPD availability
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