Multicenter Selective Lymphadenectomy Trial (MSLT)
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|ClinicalTrials.gov Identifier: NCT00275496|
Recruitment Status : Completed
First Posted : January 12, 2006
Last Update Posted : September 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Procedure: Sentinel Lymph Node Dissection Procedure: Complete Lymph Node Dissection Procedure: Wide Excision||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2001 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Study of Wide Excision Alone Versus Wide Excision With Intraoperative Lymphatic Mapping and Selective Lymph Node Dissection in the Treatment of Patients With Cutaneous Invasive Melanoma.|
|Study Start Date :||November 1993|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
|Active Comparator: WEX only||
Procedure: Wide Excision
Subject has wide excision only for primary melanoma.
|Active Comparator: WEX + SLND||
Procedure: Sentinel Lymph Node Dissection
Subject has wide excision and sentinel lymph node dissection for primary melanoma.
|Active Comparator: WEX+SLND+CLND||
Procedure: Complete Lymph Node Dissection
Subject has wide excision, sentinel lymph node dissection, and complete lymph node dissection (if positive sentinel node found) for primary melanoma.
- To determine whether wide excision of the primary with intraoperative lymphatic mapping (LM) followed by selective lymphadenectomy will effectively prolong overall survival compared to wide excision of the primary melanoma alone. [ Time Frame: 10 years ]
- Disease-free survival; Incidence, timing, and anatomic distribution of distant metastases; Morbidity of procedures; Significance of TA90 levels; Incidence of Sentinel Node Metastases (biopsy) vs clinical metastases (observation); Accuracy of LM [ Time Frame: 10 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00275496
|Study Chair:||Donald L Morton, MD||Saint John's Cancer Institute|