Lymph Node Disease, Malignant Melanoma
Conditions
Keywords
Melanoma, Lymph node disease, Adjuvant radiotherapy, Lymphoedema
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.
Interventions
RADIATIONRadiotherapy
48 Gy reference dose in 20 fractions at 5 fractions per week, with a maximum overall treatment time of 30 days.
Sponsors
University Medical Center Groningen
Australian and New Zealand Intensive Care Society Clinical Trials Group
Trans Tasman Radiation Oncology Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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) |
Countries
Australia, Brazil, Netherlands, New Zealand
Outcome results
None listed