Immediate Radiotherapy or Observation After Surgery for Melanoma Involving Lymph Nodes
NCT ID: NCT00287196
Last Updated: 2013-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
250 participants
INTERVENTIONAL
2002-03-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Post-operative RADIOTHERAPY
Immediate post-operative RADIOTHERAPY
Radiotherapy
48 Gy reference dose in 20 fractions at 5 fractions per week, with a maximum overall treatment time of 30 days.
Delayed Radiotherapy
OBSERVATION with delayed radiotherapy for relapse
Radiotherapy
48 Gy reference dose in 20 fractions at 5 fractions per week, with a maximum overall treatment time of 30 days.
Interventions
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Radiotherapy
48 Gy reference dose in 20 fractions at 5 fractions per week, with a maximum overall treatment time of 30 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* melanoma involving lymph nodes at high risk of local recurrence (details in protocol)
* No evidence of metastases
* No active major cancer within 5 years
* Normal blood tests
* WHO performance status of 0 or 1
* Radiotherapy must be able to be commenced within 12 weeks of lymphadenectomy
* Patient must not be pregnant and if fertile must use a medically acceptable contraceptive throughout treatment
* No major concurrent illnesses likely to cause death within 2 years
* Written informed consent has been given
Exclusion Criteria
* Evidence of distant metastases on clinical or radiological investigation
* Patients with prior cancers
18 Years
ALL
No
Sponsors
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University Medical Center Groningen
OTHER
Australian and New Zealand Intensive Care Society Clinical Trials Group
NETWORK
Trans Tasman Radiation Oncology Group
OTHER
Responsible Party
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Principal Investigators
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Bryan Burmeister
Role: STUDY_CHAIR
Princess Alexandra Hospital
Locations
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Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Mater Hospital - North sydney
Crows Nest, New South Wales, Australia
Calvary Mater Newcastle
Newcastle, New South Wales, Australia
Prince of Wales Hospital
Randwick, New South Wales, Australia
Westmead Hospital
Wentworthville, New South Wales, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Royal Brisbane Hospital
Herston, Queensland, Australia
Mater QRI
South Brisbane, Queensland, Australia
East Coast Cancer Centre
Tugun, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Launceston General Hospital
Launceston, Tasmania, Australia
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia
Andrew Love Cancer Care Centre, Geelong Hospital
Geelong, Victoria, Australia
Alfred Hospital
Prahran, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Hospital do Cancer
São Paulo, , Brazil
Groningen University Hospital
Groningen, , Netherlands
Auckland Hospital
Auckland, , New Zealand
Christchurch Hospital
Christchurch, , New Zealand
Dunedin Hospital
Dunedin, , New Zealand
Wellington Hospital
Wellington, , New Zealand
Countries
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References
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Henderson MA, Burmeister BH, Ainslie J, Fisher R, Di Iulio J, Smithers BM, Hong A, Shannon K, Scolyer RA, Carruthers S, Coventry BJ, Babington S, Duprat J, Hoekstra HJ, Thompson JF. Adjuvant lymph-node field radiotherapy versus observation only in patients with melanoma at high risk of further lymph-node field relapse after lymphadenectomy (ANZMTG 01.02/TROG 02.01): 6-year follow-up of a phase 3, randomised controlled trial. Lancet Oncol. 2015 Sep;16(9):1049-1060. doi: 10.1016/S1470-2045(15)00187-4. Epub 2015 Jul 20.
Burmeister BH, Henderson MA, Ainslie J, Fisher R, Di Iulio J, Smithers BM, Hong A, Shannon K, Scolyer RA, Carruthers S, Coventry BJ, Babington S, Duprat J, Hoekstra HJ, Thompson JF. Adjuvant radiotherapy versus observation alone for patients at risk of lymph-node field relapse after therapeutic lymphadenectomy for melanoma: a randomised trial. Lancet Oncol. 2012 Jun;13(6):589-97. doi: 10.1016/S1470-2045(12)70138-9. Epub 2012 May 9.
Related Links
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Click here for more information about this study on the TROG official website
Other Identifiers
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NHMRC 251732
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
ANZMTG 01.02
Identifier Type: OTHER
Identifier Source: secondary_id
TROG 02.01
Identifier Type: -
Identifier Source: org_study_id
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