Immediate Radiotherapy or Observation After Surgery for Melanoma Involving Lymph Nodes
Randomised Clinical Trial of Surgery Versus Surgery Plus Adjuvant Radiotherapy for Regional Control in Patients With Completely Resected Macroscopic Nodal Metastatic Melanoma
3 other identifiers
interventional
250
4 countries
22
Brief Summary
This trial seeks to establish the role of post-operative radiotherapy in patients who have had surgery for melanoma involving lymph nodes and who are at high risk of recurrence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2002
Longer than P75 for phase_3
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2002
CompletedFirst Submitted
Initial submission to the registry
February 3, 2006
CompletedFirst Posted
Study publicly available on registry
February 6, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedJune 25, 2013
September 1, 2009
6.7 years
February 3, 2006
June 23, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Locoregional control
Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial)
Secondary Outcomes (4)
Disease-free survival
Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial)
Overall survival
Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial)
Toxicity
Interim analysis will occur on annual basis.
Quality of life
Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial)
Study Arms (2)
Post-operative RADIOTHERAPY
ACTIVE COMPARATORImmediate post-operative RADIOTHERAPY
Delayed Radiotherapy
EXPERIMENTALOBSERVATION with delayed radiotherapy for relapse
Interventions
48 Gy reference dose in 20 fractions at 5 fractions per week, with a maximum overall treatment time of 30 days.
Eligibility Criteria
You may qualify if:
- Regional macroscopic nodal metastatic melanoma in one nodal basin region only which has been completely resected.
- 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
You may not qualify if:
- Evidence of active or previous local recurrence or in transit disease
- Evidence of distant metastases on clinical or radiological investigation
- Patients with prior cancers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Mater Hospital - North sydney
Crows Nest, New South Wales, 1585, Australia
Calvary Mater Newcastle
Newcastle, New South Wales, 2298, Australia
Prince of Wales Hospital
Randwick, New South Wales, 2031, Australia
Westmead Hospital
Wentworthville, New South Wales, 2145, Australia
Princess Alexandra Hospital
Brisbane, Queensland, 4102, Australia
Royal Brisbane Hospital
Herston, Queensland, 4029, Australia
Mater QRI
South Brisbane, Queensland, 4101, Australia
East Coast Cancer Centre
Tugun, Queensland, 4224, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Launceston General Hospital
Launceston, Tasmania, 7250, Australia
Peter MacCallum Cancer Centre
East Melbourne, Victoria, 8006, Australia
Andrew Love Cancer Care Centre, Geelong Hospital
Geelong, Victoria, 3220, Australia
Alfred Hospital
Prahran, Victoria, 3181, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009, Australia
Royal Perth Hospital
Perth, Western Australia, 6000, Australia
Hospital do Cancer
São Paulo, Brazil
Groningen University Hospital
Groningen, Netherlands
Auckland Hospital
Auckland, 1001, New Zealand
Christchurch Hospital
Christchurch, 4710, New Zealand
Dunedin Hospital
Dunedin, New Zealand
Wellington Hospital
Wellington, 7902, New Zealand
Related Publications (2)
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.
PMID: 26206146DERIVEDBurmeister 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.
PMID: 22575589DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Bryan Burmeister
Princess Alexandra Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2006
First Posted
February 6, 2006
Study Start
March 1, 2002
Primary Completion
November 1, 2008
Study Completion
December 1, 2011
Last Updated
June 25, 2013
Record last verified: 2009-09