NCT00287196

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Trans Tasman Radiation Oncology Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malignant Melanoma
• Lymph Node Disease

Interventions

Type	Name	Description
RADIATION	Radiotherapy	48 Gy reference dose in 20 fractions at 5 fractions per week, with a maximum overall treatment time of 30 days.

Timeline

• Start date: 2002-03-01
• Primary completion: 2008-11-01
• Completion: 2011-12-01
• First posted: 2006-02-06
• Last updated: 2013-06-25

Locations

22 sites across 4 countries: Australia, Brazil, Netherlands, New Zealand