Clinical trial NCT00287196: Immediate Radiotherapy or Observation After Surgery for Melanoma Involving Lymph Nodes
Official title: Randomised Clinical Trial of Surgery Versus Surgery Plus Adjuvant Radiotherapy for Regional Control in Patients With Completely Resected Macroscopic Nodal Metastatic Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malignant Melanoma
Lymph Node Disease
Keywords: Melanoma
Lymph node disease
Adjuvant radiotherapy
Lymphoedema
Lead sponsor: Trans Tasman Radiation Oncology Group
Sponsor class: OTHER
Collaborators: name: University Medical Center Groningen
name: Australian and New Zealand Intensive Care Society Clinical Trials Group
First posted: 2006-02-06
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This is a randomised phase III trial which is being performed on patients at high risk of local recurrence after having a lymphadenectomy for stage 3 melanoma. The control arm is surgery alone with radiotherapy reserved for those who recur. The study arm is surgery plus post-operative radiotherapy. All 3 major node sites are eligible. The radiation dose administered is 48Gy in 20 fractions. It is likely to be the only study of its kind ever performed. The target is 230 patients.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Evidence of active or previous local recurrence or in transit disease
* Evidence of distant metastases on clinical or radiological investigation
* Patients with prior cancers

Primary outcomes:
measure: Locoregional control
timeFrame: Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial)
Secondary outcomes:
measure: Disease-free survival
timeFrame: Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial)
measure: Overall survival
timeFrame: Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial)
measure: Toxicity
timeFrame: Interim analysis will occur on annual basis.
measure: Quality of life
timeFrame: Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial)
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Crows Nest
country: Australia
facility: Mater Hospital - North sydney
state: New South Wales
city: Newcastle
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
city: Randwick
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: Wentworthville
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Herston
country: Australia
facility: Royal Brisbane Hospital
state: Queensland
city: South Brisbane
country: Australia
facility: Mater QRI
state: Queensland
city: Tugun
country: Australia
facility: East Coast Cancer Centre
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Launceston
country: Australia
facility: Launceston General Hospital
state: Tasmania
city: East Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Geelong
country: Australia
facility: Andrew Love Cancer Care Centre, Geelong Hospital
state: Victoria
city: Prahran
country: Australia
facility: Alfred Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Sao Paulo
country: Brazil
facility: Hospital do Cancer
city: Groningen
country: Netherlands
facility: Groningen University Hospital
city: Auckland
country: New Zealand
facility: Auckland Hospital
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
city: Wellington
country: New Zealand
facility: Wellington Hospital
Study officials:
affiliation: Princess Alexandra Hospital
name: Bryan Burmeister
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.