Spots Global Cancer Trial Database for Immediate Radiotherapy or Observation After Surgery for Melanoma Involving Lymph Nodes
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Trial Identification
Brief Title: 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 ID: NCT00287196
Interventions
Study Description
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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Sao 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
Contact Details
Name: Bryan Burmeister
Affiliation: Princess Alexandra Hospital
Role: STUDY_CHAIR
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