Status:
COMPLETED
Immediate Radiotherapy or Observation After Surgery for Melanoma Involving Lymph Nodes
Lead Sponsor:
Trans Tasman Radiation Oncology Group
Collaborating Sponsors:
University Medical Center Groningen
Australian and New Zealand Intensive Care Society Clinical Trials Group
Conditions:
Malignant Melanoma
Lymph Node Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ra...
Eligibility Criteria
Inclusion
- 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
- Evidence of active or previous local recurrence or in transit disease
- Evidence of distant metastases on clinical or radiological investigation
- Patients with prior cancers
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00287196
Start Date
March 1 2002
End Date
December 1 2011
Last Update
June 25 2013
Active Locations (22)
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1
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
2
Mater Hospital - North sydney
Crows Nest, New South Wales, Australia, 1585
3
Calvary Mater Newcastle
Newcastle, New South Wales, Australia, 2298
4
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031