Multicenter Selective Lymphadenectomy Trial (MSLT)

NCT00275496 | Completed Phase 3 DMC

• 2 other identifiers: MSLT-1NIH P01 CA029605
• Study Type: interventional
• Target: 2,001
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Melanoma

Keywords

SLND; Sentinel; Melanoma; Surgical

Outcome Measures

Primary Outcomes (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.

  10 years

Secondary Outcomes (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

  10 years

Study Arms (3)

WEX only

ACTIVE COMPARATOR

Procedure: Wide Excision

WEX + SLND

ACTIVE COMPARATOR

Procedure: Sentinel Lymph Node Dissection

WEX+SLND+CLND

ACTIVE COMPARATOR

Procedure: Complete Lymph Node Dissection

Interventions

Sentinel Lymph Node Dissection PROCEDURE

Subject has wide excision and sentinel lymph node dissection for primary melanoma.

WEX + SLND

Complete Lymph Node Dissection PROCEDURE

Subject has wide excision, sentinel lymph node dissection, and complete lymph node dissection (if positive sentinel node found) for primary melanoma.

WEX+SLND+CLND

Wide Excision PROCEDURE

Subject has wide excision only for primary melanoma.

WEX only

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient consents to be in the study.
• 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.
• 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.
• 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.)
• The patient must be between 18 and 75 years old.
• The patient must have a life expectancy of at least 10 years from the time of diagnosis, excluding the diagnosis of melanoma.

You may not qualify if:

• 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.
• The primary cutaneous melanoma involves the eye, ear, mucous membranes.
• The patient has clinical evidence of satellite lesions, in-transit, regional nodal or distant metastases.
• The patient has a second primary invasive melanoma.
• 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.
• 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.
• The patient has had previous chemotherapy, immunotherapy or radiation therapy.
• The patient has had an organ transplantation and is receiving immunosuppressive agents as a result of the transplantation.
• The patient has taken oral or parenteral steroids or immunosuppressive drugs within the last 6 months.
• The patient has any known primary or secondary immune deficiencies.
• The patient has another medical condition that will affect life expectancy.
• The patient is pregnant.
• Evidence that the patient cannot undergo selective lymph node dissection for any reason.

Sponsors & Collaborators

• Saint John's Cancer Institute: lead
• National Institutes of Health (NIH): collaborator

Related Publications (4)

• Morton DL, Thompson JF, Cochran AJ, Mozzillo N, Elashoff R, Essner R, Nieweg OE, Roses DF, Hoekstra HJ, Karakousis CP, Reintgen DS, Coventry BJ, Glass EC, Wang HJ; MSLT Group. Sentinel-node biopsy or nodal observation in melanoma. N Engl J Med. 2006 Sep 28;355(13):1307-17. doi: 10.1056/NEJMoa060992.

  PMID: 17005948 RESULT

• Faries MB, Thompson JF, Cochran A, Elashoff R, Glass EC, Mozzillo N, Nieweg OE, Roses DF, Hoekstra HJ, Karakousis CP, Reintgen DS, Coventry BJ, Wang HJ, Morton DL; MSLT Cooperative Group. The impact on morbidity and length of stay of early versus delayed complete lymphadenectomy in melanoma: results of the Multicenter Selective Lymphadenectomy Trial (I). Ann Surg Oncol. 2010 Dec;17(12):3324-9. doi: 10.1245/s10434-010-1203-0. Epub 2010 Jul 8.

  PMID: 20614193 RESULT

• Howard JH, Thompson JF, Mozzillo N, Nieweg OE, Hoekstra HJ, Roses DF, Sondak VK, Reintgen DS, Kashani-Sabet M, Karakousis CP, Coventry BJ, Kraybill WG, Smithers BM, Elashoff R, Stern SL, Cochran AJ, Faries MB, Morton DL. Metastasectomy for distant metastatic melanoma: analysis of data from the first Multicenter Selective Lymphadenectomy Trial (MSLT-I). Ann Surg Oncol. 2012 Aug;19(8):2547-55. doi: 10.1245/s10434-012-2398-z. Epub 2012 May 31.

  PMID: 22648554 RESULT

• Morton DL, Thompson JF, Cochran AJ, Mozzillo N, Nieweg OE, Roses DF, Hoekstra HJ, Karakousis CP, Puleo CA, Coventry BJ, Kashani-Sabet M, Smithers BM, Paul E, Kraybill WG, McKinnon JG, Wang HJ, Elashoff R, Faries MB; MSLT Group. Final trial report of sentinel-node biopsy versus nodal observation in melanoma. N Engl J Med. 2014 Feb 13;370(7):599-609. doi: 10.1056/NEJMoa1310460.

  PMID: 24521106 DERIVED

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Donald L Morton, MD

  Saint John's Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2006
• First Posted: January 12, 2006
• Study Start: November 1, 1993
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: September 2, 2015

Record last verified: 2014-05