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
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.
Secondary ID [1] 50 0
ClinicalTrials.gov: NCT00287196
Secondary ID [2] 51 0
National Clinical Trials Registry: NCTR487
Universal Trial Number (UTN)
Trial acronym
TROG 02.01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic melanoma 46 0
Lymph node disease 47 0
Condition category
Condition code
Cancer 53 53 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 1302 0
Treatment: Other
Comparator / control treatment
ARM 2: Observation with delayed radiotherapy for relapse. Dose is at treating physician discretion.
Control group
Active

Outcomes
Primary outcome [1] 86 0
Rate of regional relapse - Time to regional failure.
Timepoint [1] 86 0
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.
Secondary outcome [1] 169 0
Failure free survival
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.
Secondary outcome [2] 170 0
Overall survival
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.
Secondary outcome [3] 171 0
Toxicity
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.
Secondary outcome [4] 172 0
Quality of Life
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.

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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)
Central randomisation by computer
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.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/03/2002
Actual
20/03/2002
Date of last participant enrolment
Anticipated
Actual
21/09/2007
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
250
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 4769 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [2] 4770 0
Mater Sydney - North Sydney
Recruitment hospital [3] 4771 0
Prince of Wales Hospital - Randwick
Recruitment hospital [4] 4772 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [5] 4773 0
Westmead Private Hospital - Westmead
Recruitment hospital [6] 4774 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [7] 4775 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [8] 4776 0
Launceston General Hospital - Launceston
Recruitment hospital [9] 4777 0
The Alfred - Prahran
Recruitment hospital [10] 4778 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment hospital [11] 4779 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [12] 4780 0
Royal Perth Hospital - Perth
Recruitment outside Australia
Country [1] 387 0
New Zealand
State/province [1] 387 0
Country [2] 7385 0
Netherlands
State/province [2] 7385 0
Country [3] 7386 0
Brazil
State/province [3] 7386 0

Funding & Sponsors
Funding source category [1] 75 0
Government body
Name [1] 75 0
National Health & Medical Research Council
Country [1] 75 0
Australia
Funding source category [2] 76 0
Government body
Name [2] 76 0
Anti-Cancer Council of South Australia
Country [2] 76 0
Australia
Primary sponsor type
Individual
Name
Bryan Burmeister
Address
Princess Alexandra Hospital Oncology Services Ipswich Road Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 63 0
Other Collaborative groups
Name [1] 63 0
Trans Tasman Radiation Oncology Group (TROG)
Address [1] 63 0
Edith St Waratah NSW 2298
Country [1] 63 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 563 0
William Buckland Radiotherapy Centre, The Alfred
Ethics committee address [1] 563 0
Ethics committee country [1] 563 0
Australia
Date submitted for ethics approval [1] 563 0
Approval date [1] 563 0
01/08/2002
Ethics approval number [1] 563 0
Ethics committee name [2] 564 0
Andrew Love Cancer Centre, Geelong Hospital
Ethics committee address [2] 564 0
Ethics committee country [2] 564 0
Australia
Date submitted for ethics approval [2] 564 0
Approval date [2] 564 0
Ethics approval number [2] 564 0
Ethics committee name [3] 565 0
Auckland Hospital
Ethics committee address [3] 565 0
Ethics committee country [3] 565 0
New Zealand
Date submitted for ethics approval [3] 565 0
Approval date [3] 565 0
Ethics approval number [3] 565 0
Ethics committee name [4] 566 0
Christchurch Hospital
Ethics committee address [4] 566 0
Ethics committee country [4] 566 0
New Zealand
Date submitted for ethics approval [4] 566 0
Approval date [4] 566 0
Ethics approval number [4] 566 0
Ethics committee name [5] 567 0
Dunedin Hospital
Ethics committee address [5] 567 0
Ethics committee country [5] 567 0
New Zealand
Date submitted for ethics approval [5] 567 0
Approval date [5] 567 0
Ethics approval number [5] 567 0
Ethics committee name [6] 568 0
Premion Tugun
Ethics committee address [6] 568 0
Ethics committee country [6] 568 0
Australia
Date submitted for ethics approval [6] 568 0
Approval date [6] 568 0
Ethics approval number [6] 568 0
Ethics committee name [7] 569 0
Groningen University Hospital
Ethics committee address [7] 569 0
Ethics committee country [7] 569 0
Netherlands
Date submitted for ethics approval [7] 569 0
Approval date [7] 569 0
Ethics approval number [7] 569 0
Ethics committee name [8] 570 0
Launceston Hospital
Ethics committee address [8] 570 0
Ethics committee country [8] 570 0
Australia
Date submitted for ethics approval [8] 570 0
Approval date [8] 570 0
Ethics approval number [8] 570 0
Ethics committee name [9] 571 0
Mater Hospital
Ethics committee address [9] 571 0
Ethics committee country [9] 571 0
Australia
Date submitted for ethics approval [9] 571 0
Approval date [9] 571 0
Ethics approval number [9] 571 0
Ethics committee name [10] 572 0
Calvary Mater Newcastle
Ethics committee address [10] 572 0
Ethics committee country [10] 572 0
Australia
Date submitted for ethics approval [10] 572 0
Approval date [10] 572 0
Ethics approval number [10] 572 0
Ethics committee name [11] 573 0
Peter MacCallum Cancer Centre
Ethics committee address [11] 573 0
Ethics committee country [11] 573 0
Australia
Date submitted for ethics approval [11] 573 0
Approval date [11] 573 0
Ethics approval number [11] 573 0
Ethics committee name [12] 574 0
Princess Alexandra Hospital
Ethics committee address [12] 574 0
Ethics committee country [12] 574 0
Australia
Date submitted for ethics approval [12] 574 0
Approval date [12] 574 0
Ethics approval number [12] 574 0
Ethics committee name [13] 575 0
Prince of Wales Hospital
Ethics committee address [13] 575 0
Ethics committee country [13] 575 0
Australia
Date submitted for ethics approval [13] 575 0
Approval date [13] 575 0
Ethics approval number [13] 575 0
Ethics committee name [14] 576 0
Mater Centre QRI
Ethics committee address [14] 576 0
Ethics committee country [14] 576 0
Australia
Date submitted for ethics approval [14] 576 0
Approval date [14] 576 0
Ethics approval number [14] 576 0
Ethics committee name [15] 577 0
Royal Adelaide Hospital
Ethics committee address [15] 577 0
Ethics committee country [15] 577 0
Australia
Date submitted for ethics approval [15] 577 0
Approval date [15] 577 0
Ethics approval number [15] 577 0
Ethics committee name [16] 578 0
Royal Brisbane and Women's Hospital
Ethics committee address [16] 578 0
Ethics committee country [16] 578 0
Australia
Date submitted for ethics approval [16] 578 0
Approval date [16] 578 0
Ethics approval number [16] 578 0
Ethics committee name [17] 579 0
Royal Perth Hospital
Ethics committee address [17] 579 0
Ethics committee country [17] 579 0
Australia
Date submitted for ethics approval [17] 579 0
Approval date [17] 579 0
Ethics approval number [17] 579 0
Ethics committee name [18] 580 0
Royal Prince Alfred Hospital
Ethics committee address [18] 580 0
Ethics committee country [18] 580 0
Australia
Date submitted for ethics approval [18] 580 0
Approval date [18] 580 0
Ethics approval number [18] 580 0
Ethics committee name [19] 581 0
Royal Prince Alfred Hospital
Ethics committee address [19] 581 0
Ethics committee country [19] 581 0
Australia
Date submitted for ethics approval [19] 581 0
Approval date [19] 581 0
Ethics approval number [19] 581 0
Ethics committee name [20] 582 0
Wellington Hospital
Ethics committee address [20] 582 0
Ethics committee country [20] 582 0
New Zealand
Date submitted for ethics approval [20] 582 0
Approval date [20] 582 0
Ethics approval number [20] 582 0
Ethics committee name [21] 583 0
Westmead Hospital
Ethics committee address [21] 583 0
Ethics committee country [21] 583 0
Australia
Date submitted for ethics approval [21] 583 0
Approval date [21] 583 0
Ethics approval number [21] 583 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35232 0
Prof Bryan Burmeister
Address 35232 0
Princess Alexandra Hospital Oncology Services Ipswich Road Woolloongabba QLD 4102
Country 35232 0
Australia
Phone 35232 0
+61 7 3240 6584
Fax 35232 0
Email 35232 0
[email protected]
Contact person for public queries
Name 10491 0
Juliana Dilulio
Address 10491 0
Department of Radiation Oncology
Locked Bag 1
A'Beckett Street
VIC 8006
Country 10491 0
Australia
Phone 10491 0
+61 3 9656 3786
Fax 10491 0
Email 10491 0
[email protected]
Contact person for scientific queries
Name 1419 0
Bryan Burmeister
Address 1419 0
Princess Alexandra Hospital
Oncology Services
Ipswich Road
Woolloongabba QLD 4102
Country 1419 0
Australia
Phone 1419 0
+61 7 3240 6584
Fax 1419 0
Email 1419 0
[email protected]

No information has been provided regarding IPD availability


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