Immediate Radiotherapy or Observation After Surgery for Melanoma Involving Lymph Nodes

Phase 3

Completed

• Conditions: Malignant Melanoma; Lymph Node Disease
• Interventions: Radiation: Radiotherapy

• Registration Number: NCT00287196
• Lead Sponsor: Trans Tasman Radiation Oncology Group

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.

Study Timeline

• Study Start: 2002-03
• Study First Submitted: 2006-02-03
• Study First Submitted QC: 2006-02-03
• Study First Posted: 2006-02-06
• Primary Completion: 2008-11
• Status Verified: 2009-09
• Study Completion: 2011-12
• Last Update Submitted: 2013-06-23
• Last Update Posted: 2013-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Post-operative RADIOTHERAPY	Radiotherapy	Immediate post-operative RADIOTHERAPY
Delayed Radiotherapy	Radiotherapy	OBSERVATION with delayed radiotherapy for relapse

Primary Outcome Measures

Name	Time	Method
Locoregional control	Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (22)

Mater Hospital - North sydney; 🇦🇺 Crows Nest, New South Wales, Australia

Sir Charles Gairdner Hospital; 🇦🇺 Nedlands, Western Australia, Australia

Royal Perth Hospital; 🇦🇺 Perth, Western Australia, Australia

Royal Prince Alfred Hospital; 🇦🇺 Camperdown, New South Wales, Australia

Royal Brisbane Hospital; 🇦🇺 Herston, Queensland, Australia

Royal Adelaide Hospital; 🇦🇺 Adelaide, South Australia, Australia

Andrew Love Cancer Care Centre, Geelong Hospital; 🇦🇺 Geelong, Victoria, Australia

Alfred Hospital; 🇦🇺 Prahran, Victoria, Australia

Auckland Hospital; 🇳🇿 Auckland, New Zealand

Wellington Hospital; 🇳🇿 Wellington, New Zealand

Westmead Hospital; 🇦🇺 Wentworthville, New South Wales, Australia

Peter MacCallum Cancer Centre; 🇦🇺 East Melbourne, Victoria, Australia

Princess Alexandra Hospital; 🇦🇺 Brisbane, Queensland, Australia

East Coast Cancer Centre; 🇦🇺 Tugun, Queensland, Australia

Launceston General Hospital; 🇦🇺 Launceston, Tasmania, Australia

Groningen University Hospital; 🇳🇱 Groningen, Netherlands

Dunedin Hospital; 🇳🇿 Dunedin, New Zealand

Calvary Mater Newcastle; 🇦🇺 Newcastle, New South Wales, Australia

Prince of Wales Hospital; 🇦🇺 Randwick, New South Wales, Australia

Hospital do Cancer; 🇧🇷 Sao Paulo, Brazil

Christchurch Hospital; 🇳🇿 Christchurch, New Zealand

Mater QRI; 🇦🇺 South Brisbane, Queensland, Australia