Trial Status: Open

Treatment type: Surgical

Stage of disease: Stage IIA to IIIC

Intent of treatment: Prevention of recurrence

A phase III multicentre randomised trial of sentinel node biopsy and complete lymph node dissection versus sentinel node biopsy alone, in cutaneous melanoma patients with molecular or histopathological evidence of metastases in the sentinel node.

MSLT II (the second Multicentre Selective Lymphadenectomy Trial) is a Phase III clinical trial being conducted at 42 sites worldwide. At the SMU we have enrolled over 900 patients since December 2004 and we are the highest recruiter.

The trial sponsor is the John Wayne Cancer Institute (JWCI) in California, USA.

The primary objective of the trial is to determine whether sentinel node biopsy (SNB) and complete lymph node dissection (CLND) in patients with a positive sentinel node (either by histopathological or molecular evaluation) will lead to longer disease specific survival than SNB alone and serial ultrasound (U/S) monitoring.

Screening Phase - The Screening Phase involves a molecular test (RT-PCR) that is available at the JWCI.  If a patient’s SNB result is negative for melanoma cells from pathology here, the lymph node tissue is sent to the US for molecular evaluation. Approximately 80% return negative, 20% come back positive.

A positive RT-PCR result is treated as a positive result from pathology and current standard treatment is to remove all the remaining lymph nodes from the area. However, surgeons are questioning whether this surgery is necessary as new data indicate that 80 – 85% of people with a positive sentinel node have no other involved nodes.

Randomisation  Phase - The Randomisation Phase is a ten year study and it is comprised of 2 groups.  One group has standard treatment and the other group has regular U/S of the lymph nodes. If the patient decides to participate in the Randomisation Phase, they cannot choose which group to be in.  A computer at the JWCI randomises the patient to either group and the patient is strongly encouraged to accept the randomisation result.

Contacts

Principal Investigator; Professor John Thompson

Jo Dalton - Trial Coordinator            Tel: +61 2 9911 7303

Valerie Jakrot - Trial Coordinator       Tel: +61 2 9911 7306