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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
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Saint John's Cancer Institute

Brief Summary:
Subjects must be diagnosed with melanoma. All subjects receive Wide Excision (WEX) of their melanoma. If the melanoma meets study requirements, the subject is randomized to receive either (1) no further surgical procedures as part of the study or (2) a Selective Lymphadenectomy with the possibility of a Complete Lymphadenectomy. Subjects are then followed for 10 years.

Condition or disease Intervention/treatment Phase
Melanoma Procedure: Sentinel Lymph Node Dissection Procedure: Complete Lymph Node Dissection Procedure: Wide Excision Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2001 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. The patient consents to be in the study.
  2. The patient must have invasive melanoma with: 1) Clark Level III and Breslow Thickness greater than or equal to 1.00 mm; or 2) Clark Level IV or V with any Breslow thickness. A confirmation of diagnosis and thickness must be made by the institutional pathologist.
  3. The primary cutaneous melanoma site must be on the head, neck, trunk, extremity, scalp, palm of the hand, sole of the foot, or subungual skin.
  4. The patient's biopsy must have been completed no more than 10 weeks before the initial visit to the clinic. (Surgery must be scheduled within three months of the biopsy.)
  5. The patient must be between 18 and 75 years old.
  6. The patient must have a life expectancy of at least 10 years from the time of diagnosis, excluding the diagnosis of melanoma.

Exclusion Criteria:

  1. The patient had a prior wide excision of the primary with a diameter of excision greater than or equal to 3.0 cm and the shortest margin from the tumor edge to the excision edge was measured by a pathologist to be greater than or equal to 1.5 cm; or the patient had an elliptical excision and a margin beyond the tumor edge was greater than or equal to 1.5 cm at the narrowest margin.
  2. The primary cutaneous melanoma involves the eye, ear, mucous membranes.
  3. The patient has clinical evidence of satellite lesions, in-transit, regional nodal or distant metastases.
  4. The patient has a second primary invasive melanoma.
  5. The patient has had any type of solid tumor or hematologic malignancy during the past 5 years. Exceptions are if the patient has been treated for T1 lesions (e.g., squamous cell carcinoma of the skin, basal cell carcinoma or in situ carcinoma of the uterine cervix) during the past 5 years, but has not received treatment within the last 6 months.
  6. The patient has had prior skin grafts, tissue transfers or flaps, or lymph node dissections that may alter the lymphatic drainage pattern from a primary cutaneous melanoma to the adjacent regional lymph node basins.
  7. The patient has had previous chemotherapy, immunotherapy or radiation therapy.
  8. The patient has had an organ transplantation and is receiving immunosuppressive agents as a result of the transplantation.
  9. The patient has taken oral or parenteral steroids or immunosuppressive drugs within the last 6 months.
  10. The patient has any known primary or secondary immune deficiencies.
  11. The patient has another medical condition that will affect life expectancy.
  12. The patient is pregnant.
  13. Evidence that the patient cannot undergo selective lymph node dissection for any reason.

Information from the National Library of Medicine

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

Sponsors and Collaborators
Saint John's Cancer Institute
National Institutes of Health (NIH)
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Study Chair: Donald L Morton, MD Saint John's Cancer Institute
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Saint John's Cancer Institute
ClinicalTrials.gov Identifier: NCT00275496    
Other Study ID Numbers: MSLT-1
NIH P01 CA029605
First Posted: January 12, 2006    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: May 2014
Keywords provided by Saint John's Cancer Institute:
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas