Multicenter Selective Lymphadenectomy Trial II (MSLT-II)

NCT00297895 | Completed DMC

• 3 other identifiers: MSLT-IIP01CA029605R01CA189163
• Study Type: interventional
• Target: 1,939
• Locations: 12 countries
• Sites: 63

Brief Summary

Subjects must be diagnosed with melanoma. All subjects receive sentinel lymphadenectomy. If the subject is sentinel node positive and meets study requirements, the subject is randomized to receive either (1) completion lymphadenectomy (2) observation with nodal ultrasound. Subjects are then followed for 10 years.

Conditions

Melanoma

Keywords

sentinel lymph node dissection; complete lymph node dissection; surgical

Outcome Measures

Primary Outcomes (1)

• Melanoma-specific survival. This is defined as the time between the date of a subject's randomization (or date of CLND for those randomized to the CLND arm) and the date of death due to melanoma. Subjects are followed until death or 10yrs.

  10 years

Secondary Outcomes (2)

• Disease-free survival over 10 years of follow up

  10 years

• Recurrence during 10 years of follow up

  10 years

Study Arms (2)

Ultrasound observation + delayed CLND if recurrence detected

ACTIVE COMPARATOR

Procedure: Monitoring with nodal ultrasound

CLND

ACTIVE COMPARATOR

Procedure: Completion Lymphadenectomy

Interventions

Completion Lymphadenectomy PROCEDURE

complete lymph node dissection of lymph node basin with positive node

CLND

Monitoring with nodal ultrasound PROCEDURE

serial ultrasound monitoring of SLND positive basin. If recurrence detected, subject has CLND.

Ultrasound observation + delayed CLND if recurrence detected

Eligibility Criteria

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

You may qualify if:

• Ability to provide informed consent.
• Between 18 and 75 years of age.
• Have a primary melanoma that is cutaneous (including head, neck, trunk, extremity, scalp, palm, sole, subungual skin tissues).
• Have clear margins following WLE.
• ECOG performance status 0-1.
• Life expectancy of at least 10 years from the time of diagnosis, not considering the melanoma in question, as determined by the PI.
• Willing to return to the MSLT-II center for follow up examinations and procedures as outlined in the protocol.
• Randomization and/or CLND (as appropriate to randomization arm) must be completed no more than 120 days following the diagnostic biopsy of the primary melanoma.
• Have a melanoma-related tumor-positive SN, determined by either of the following methods:
• Diagnosis of tumor-positive SN by MSLT-II center institutional pathologist by either H\&E or IHC (using S-100, Mart-1, and HMB-45).
• Diagnosis of tumor-positive SN by RT-PCR analysis performed at JWCI, provided the primary melanoma fits into one of the following categories:
• Breslow thickness of 1.20 mm or greater and Clark Level III
• Clark Level IV or V, regardless of Breslow thickness
• Ulceration, regardless of Breslow thickness or Clark level

You may not qualify if:

• History of previous or concurrent (i.e., second primary) invasive melanoma.
• Primary melanoma of the eye, ears, mucous membranes or internal viscera. (Primary of the skin of the external ear is acceptable.)
• Physical, clinical, radiographic or pathologic evidence of satellite, in-transit, regional, or distant metastatic disease.
• Any additional solid tumor or hematologic malignancy during the past 5 years except T1 skin lesions of squamous cell carcinoma, basal cell carcinoma, or uterine cervical cancer.
• Skin grafts, tissue transfers or flaps that have the potential to alter the lymphatic drainage pattern from the primary melanoma to a LN basin.
• Allergy to vital blue dye or any radiocolloid.
• Inability to localize 1-2 SN drainage basins via LM (e.g., no basins found, more than 2 basins found, proximity of the primary melanoma to the regional draining basin, etc.)
• CLNDs or SLs (before evaluation of the current melanoma) that may have altered the lymphatic drainage pattern from the primary cutaneous melanoma to a potential LN basin.
• Organic brain syndrome or significant impairment of basal cognitive function or any psychiatric disorder that might preclude participation in the full protocol, or be exacerbated by therapy (e.g., severe depression).
• Melanoma-related operative procedures not corresponding to criteria described in the protocol.
• Primary or secondary immune deficiencies or known significant autoimmune disease.
• History of organ transplantation.
• Oral or parenteral immunosuppressive agents (not topical or inhaled steroids) at any time during study participation or within 6 months prior to enrollment.
• Pregnant or lactating women.
• Participation in concurrent therapy protocols of alternative local nodal basin therapies that might confound the analysis of this trial is not permitted. For example, radiation of a non-resected node basin is not acceptable because it might influence outgrowth of residual melanoma in that nodal basin. However, systemic adjuvant therapy or clinical trial adjuvant protocols after the finding of a positive node on LM/SL or delayed nodal recurrence in the ultrasound observation arm are both acceptable according to the standard of care at the multicenter site. Patients with positive sentinel nodes or thick primary melanomas who are considered by the multicenter site's investigator as high-risk may receive systemic adjuvant therapy according to the standard practice of that particular site.

Sponsors & Collaborators

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

Study Sites (63)

Sharp Hospital

San Diego, California, 92123, United States

Location

John Wayne Cancer Institute

Santa Monica, California, 90404, United States

Location

Memorial Hospital - Colorado Springs

Colorado Springs, Colorado, 809030-3658, United States

Location

Lakeland Regional Cancer Center

Lakeland, Florida, 33805, United States

Location

H. Lee Moffitt Cancer Center

Tampa, Florida, 33612-9497, United States

Location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Rush University

Chicago, Illinois, 60612-3824, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

Johns Hopkins Medical Institute

Baltimore, Maryland, 21287, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109-0932, United States

Location

St. Louis University

St Louis, Missouri, 63110-8566, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Buffalo General Hospital

Buffalo, New York, 14209, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Feinstein Institute for Medical Research

Great Neck, New York, 11021, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

SUNY at Stony Brook Hospital Medical Center

Stony Brook, New York, 11794-8191, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

St. Luke's Hospital

Bethlehem, Pennsylvania, 18015, United States

Location

Geisinger Clinic

Danville, Pennsylvania, 17822, United States

Location

Pennsylvania State Hershey Cancer Institute

Hershey, Pennsylvania, 17033, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Main Line Surgeons

Wynnewood, Pennsylvania, 19096, United States

Location

Greenville Hospital System Cancer Center

Greenville, South Carolina, 29605, United States

Location

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232-6868, United States

Location

Dallas Surgical Group

Dallas, Texas, 75235, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

IHC Cancer Services Intermountain Medical Center

Salt Lake City, Utah, 84103, United States

Location

Hunstman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Sentara Careplex Hospital

Newport News, Virginia, 23606, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Newcastle Melanoma Unit

Newcastle, New South Wales, 2298, Australia

Location

Melanoma Institute Australia

Sydney, New South Wales, 2060, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Alfred Hospital

East Hawthorn, Victoria, 3123, Australia

Location

Peter MacCallum Cancer Centre

East Melbourne, Victoria, 3677, Australia

Location

Tom Baker Cancer Center

Calgary, Alberta, T2N 4N1, Canada

Location

Sunnybrook Health Sciences Center

Toronto, Ontario, M4N3M5, Canada

Location

Helsinki Unversity Hospital

Helsinki, 00029 HUS, Finland

Location

U. Hosp. Schleswig-Holstein/Campus Lubeck

Lübeck, 23538, Germany

Location

City Hospital of Nurnberg

Nuremberg, 90419, Germany

Location

University of Wurzburg

Würzburg, 97080, Germany

Location

Tel-Aviv Sourasky Medical Center

Tel Aviv, 94239, Israel

Location

Istituto Europeo di Oncologia

Milan, 20141, Italy

Location

Istituto Nazionale dei Tumori Napoli

Naples, 80121, Italy

Location

Istituto Oncologico Veneto - University of Padova

Padua, 35128, Italy

Location

Padua University - Clinica Chirurgica II

Padua, 35128, Italy

Location

Netherlands Cancer Institute

Amsterdam, 1066 CX, Netherlands

Location

Universitair Medisch Centrum Groningen

Groningen, 9700 RB, Netherlands

Location

Hospital Clinic Barcelona

Barcelona, 08036, Spain

Location

Swedish Melanoma Study Group

Lund, S-221 85, Sweden

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH 1011, Switzerland

Location

University of Zurich

Zurich, CH-8091, Switzerland

Location

Norfolk and Norwich University Hospital

Norfolk, Norwich, NR4 7UY, United Kingdom

Location

Saint Thomas's Hospital

London, SE17EH, United Kingdom

Location

Related Publications (2)

• Multicenter Selective Lymphadenectomy Trials Study Group; Crystal JS, Thompson JF, Hyngstrom J, Caraco C, Zager JS, Jahkola T, Bowles TL, Pennacchioli E, Beitsch PD, Hoekstra HJ, Moncrieff M, Ingvar C, van Akkooi A, Sabel MS, Levine EA, Agnese D, Henderson M, Dummer R, Neves RI, Rossi CR, Kane JM 3rd, Trocha S, Wright F, Byrd DR, Matter M, Hsueh EC, MacKenzie-Ross A, Kelley M, Terheyden P, Huston TL, Wayne JD, Neuman H, Smithers BM, Ariyan CE, Desai D, Gershenwald JE, Schneebaum S, Gesierich A, Jacobs LK, Lewis JM, McMasters KM, O'Donoghue C, van der Westhuizen A, Sardi A, Barth R, Barone R, McKinnon JG, Slingluff CL, Farma JM, Schultz E, Scheri RP, Vidal-Sicart S, Molina M, Testori AAE, Foshag LJ, Van Kreuningen L, Wang HJ, Sim MS, Scolyer RA, Elashoff DE, Cochran AJ, Faries MB. Therapeutic Value of Sentinel Lymph Node Biopsy in Patients With Melanoma: A Randomized Clinical Trial. JAMA Surg. 2022 Sep 1;157(9):835-842. doi: 10.1001/jamasurg.2022.2055.

  PMID: 35921122 DERIVED

• Faries MB, Thompson JF, Cochran AJ, Andtbacka RH, Mozzillo N, Zager JS, Jahkola T, Bowles TL, Testori A, Beitsch PD, Hoekstra HJ, Moncrieff M, Ingvar C, Wouters MWJM, Sabel MS, Levine EA, Agnese D, Henderson M, Dummer R, Rossi CR, Neves RI, Trocha SD, Wright F, Byrd DR, Matter M, Hsueh E, MacKenzie-Ross A, Johnson DB, Terheyden P, Berger AC, Huston TL, Wayne JD, Smithers BM, Neuman HB, Schneebaum S, Gershenwald JE, Ariyan CE, Desai DC, Jacobs L, McMasters KM, Gesierich A, Hersey P, Bines SD, Kane JM, Barth RJ, McKinnon G, Farma JM, Schultz E, Vidal-Sicart S, Hoefer RA, Lewis JM, Scheri R, Kelley MC, Nieweg OE, Noyes RD, Hoon DSB, Wang HJ, Elashoff DA, Elashoff RM. Completion Dissection or Observation for Sentinel-Node Metastasis in Melanoma. N Engl J Med. 2017 Jun 8;376(23):2211-2222. doi: 10.1056/NEJMoa1613210.

  PMID: 28591523 DERIVED

Related Links

• John Wayne Cancer Institute Clinical Trials (sponsor)

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

• Richard Essner, M.D.

  Saint John's Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2006
• First Posted: March 1, 2006
• Study Start: September 30, 2004
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: May 13, 2022

Record last verified: 2022-05

Locations

SE (1); CH (2); IL (1); GB (2); US (39); DE (3); NL (2); CA (2); AU (5); ES (1); IT (4); FI (1)