Immediate Radiotherapy or Observation After Surgery for Melanoma Involving Lymph Nodes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomised Clinical Trial of Surgery Versus Surgery Plus Adjuvant Radiotherapy for Regional Control in Patients With Completely Resected Macroscopic Nodal Metastatic Melanoma

Conditions
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Malignant Melanoma, Lymph Node Disease

Intervention / Treatment
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* Radiation: Radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Post-operative RADIOTHERAPY<br>Immediate post-operative RADIOTHERAPY | Radiation: Radiotherapy<br>* 48 Gy reference dose in 20 fractions at 5 fractions per week, with a maximum overall treatment time of 30 days.<br>* Other names: Radiation;|
| Experimental: Delayed Radiotherapy<br>OBSERVATION with delayed radiotherapy for relapse | Radiation: Radiotherapy<br>* 48 Gy reference dose in 20 fractions at 5 fractions per week, with a maximum overall treatment time of 30 days.<br>* Other names: Radiation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melanoma, Lymph node disease, Adjuvant radiotherapy, Lymphoedema