[Randomized melanoma study of perfusion of the extremities. Results of treatment 2 1/2 years after premature discontinuation].

To evaluate the effectiveness of regional hyperthermic cytostatic perfusion in patients with malignant melanomas of the extremities 107 patients were included in a prospective randomized study. In a control group (A, n = 54) the tumors were excised widely and the regional lymph nodes were dissected. The patients in the perfusion group (B, n = 53) received additional hyperthermic (42 degrees C) perfusion with Melphalan. We chose the disease-free-survival time as the criterion for success. An intermediate evaluation (mean follow-up observation period of 550 days) revealed a highly significant difference between the groups (p = 0.0001) of 21 resp. 4 recurrences. A second evaluation, 2 1/2 years after prematurely discontinuation, also shows a highly significant difference in favour of perfusion (p = 0.0001).

RCT Entities:   Population Interventions Outcomes