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

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.

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.

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