MSLT II
A phase III multicenter randomised trial of sentinel lymphadenectomy and node dissection versus sentinel lymphodenectomy alone, in cutaneous melanoma with molecular or histopathological evidence of metastasis in the sentinel node.
Contact person: Jo Dalton, SMU phone; 02 9911 7303 or Phone 02 9515 8880 and use Pager # 88032 and follow the prompts. Valerie Jakrot, SMU 02 9911 7306 or Phone 02 9515 8880 and use Pager # 80098.
Dr Pauline Hanrahan, Newcastle Melanoma Unit phone: 02 4985 0179
INCLUSION CRITERIA
- 18 – 75 years
- Primary melanoma is cutaneous. Must not be of the eye, mucous membranes or internal viscera.
- Breslow thickness greater than or equal to 1.2 mm and Clark Level III or Clark Level IV or ulceration.
- Life expectancy of at least 10 years from date of Dx.
- ECOG status 0-1.
- Willingness to return to SMU for 10 years for follow up.
- Randomisation and/or CLND must be completed no more than 120 days following diagnostic biopsy of primary melanoma.
EXCLUSION CRITERIA
- Previous or concurrent melanoma (ie second primary)
- Solid tumour or hematologic malignancy during the last 5 years excluding SCC’s, BCC’s and uterine cervical cancer
- Previous skin grafts, tissue transfers, flaps or LND or SNB that may have altered lymphatic drainage pattern
- History of autoimmune disease, history of organ transplantation
- Pregnant or lactating women
- Significant cognitive impairment or psychiatric disorder
- Use of oral or parenteral immunosuppressive agents (topical and inhaled steroids excepted) currently or in the last 6 months
- Enrolment in other concurrent experimental treatments or alternative therapies. Adjuvant therapy acceptable after recurrence.
