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Multicenter Selective Lymphadenectomy Trial (MSLT) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Multicenter Selective Lymphadenectomy Trial (MSLT)

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.

NCT00275496•Saint John's Cancer Institute

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.
+3 more criteria

Key Dates

Start Date

November 1, 1993

Primary Completion Date

June 1, 2012

Completion Date

June 1, 2012

Last Updated

September 2, 2015

Enrollment

2,001

ACTUAL participants

Conditions

Melanoma

Interventions

Sentinel Lymph Node Dissection

PROCEDURE

Complete Lymph Node Dissection

PROCEDURE

Wide Excision

PROCEDURE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 2, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Multicenter Selective Lymphadenectomy Trial (MSLT)

Inclusion Criteria

Exclusion Criteria

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma

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Narrow Excision Versus Wide Excision for the Treatment of Adults With Invasive Cutaneous Melanoma, ICEMAN Trial

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