Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Trans Tasman Radiation Oncology Group
With
University Medical Center Groningen
Australian and New Zealand Intensive Care Society Clinical Trials Group
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
Evidence of active or previous local recurrence or in transit disease
Evidence of distant metastases on clinical or radiological investigation
Patients with prior cancers
Clareo Health | Immediate Radiotherapy or Observation After Surgery for Melanoma Involving Lymph Nodes
