Multicenter Selective Lymphadenectomy Trial II (MSLT-II)

NCT ID: NCT00297895

Last Updated: 2022-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1939 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2019-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ultrasound observation + delayed CLND if recurrence detected

Group Type: ACTIVE_COMPARATOR

Monitoring with nodal ultrasound

Intervention Type: PROCEDURE

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

CLND

Group Type: ACTIVE_COMPARATOR

Completion Lymphadenectomy

Intervention Type: PROCEDURE

complete lymph node dissection of lymph node basin with positive node

Interventions

Completion Lymphadenectomy

complete lymph node dissection of lymph node basin with positive node

Intervention Type: PROCEDURE

Monitoring with nodal ultrasound

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Ability to provide informed consent.

2. Between 18 and 75 years of age.

3. Have a primary melanoma that is cutaneous (including head, neck, trunk, extremity, scalp, palm, sole, subungual skin tissues).

4. Have clear margins following WLE.

5. ECOG performance status 0-1.

6. Life expectancy of at least 10 years from the time of diagnosis, not considering the melanoma in question, as determined by the PI.

7. Willing to return to the MSLT-II center for follow up examinations and procedures as outlined in the protocol.

8. 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.

9. Have a melanoma-related tumor-positive SN, determined by either of the following methods:

1. 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).

2. 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

Exclusion Criteria

1. History of previous or concurrent (i.e., second primary) invasive melanoma.

2. Primary melanoma of the eye, ears, mucous membranes or internal viscera. (Primary of the skin of the external ear is acceptable.)

3. Physical, clinical, radiographic or pathologic evidence of satellite, in-transit, regional, or distant metastatic disease.

4. 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.

5. Skin grafts, tissue transfers or flaps that have the potential to alter the lymphatic drainage pattern from the primary melanoma to a LN basin.

6. Allergy to vital blue dye or any radiocolloid.

7. 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.)

8. 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.

9. 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).

10. Melanoma-related operative procedures not corresponding to criteria described in the protocol.

11. Primary or secondary immune deficiencies or known significant autoimmune disease.

12. History of organ transplantation.

13. Oral or parenteral immunosuppressive agents (not topical or inhaled steroids) at any time during study participation or within 6 months prior to enrollment.

14. Pregnant or lactating women.

15. 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.

16. SLND pathology shows, on microscopic examination, that melanoma extends through the lymph node capsule into the adjacent soft tissue.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Saint John's Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Essner, M.D.

Role: PRINCIPAL_INVESTIGATOR

Saint John's Cancer Institute

Locations

Sharp Hospital

San Diego, California, United States

John Wayne Cancer Institute

Santa Monica, California, United States

Memorial Hospital - Colorado Springs

Colorado Springs, Colorado, United States

Lakeland Regional Cancer Center

Lakeland, Florida, United States

H. Lee Moffitt Cancer Center

Tampa, Florida, United States

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Rush University

Chicago, Illinois, United States

University of Louisville

Louisville, Kentucky, United States

Mercy Medical Center

Baltimore, Maryland, United States

Johns Hopkins Medical Institute

Baltimore, Maryland, United States

University of Michigan

Ann Arbor, Michigan, United States

St. Louis University

St Louis, Missouri, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Buffalo General Hospital

Buffalo, New York, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Feinstein Institute for Medical Research

Great Neck, New York, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

SUNY at Stony Brook Hospital Medical Center

Stony Brook, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Wake Forest University

Winston-Salem, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

Ohio State University

Columbus, Ohio, United States

St. Luke's Hospital

Bethlehem, Pennsylvania, United States

Geisinger Clinic

Danville, Pennsylvania, United States

Pennsylvania State Hershey Cancer Institute

Hershey, Pennsylvania, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Main Line Surgeons

Wynnewood, Pennsylvania, United States

Greenville Hospital System Cancer Center

Greenville, South Carolina, United States

University of Tennessee Medical Center

Knoxville, Tennessee, United States

Vanderbilt University

Nashville, Tennessee, United States

Dallas Surgical Group

Dallas, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

IHC Cancer Services Intermountain Medical Center

Salt Lake City, Utah, United States

Hunstman Cancer Institute

Salt Lake City, Utah, United States

University of Virginia

Charlottesville, Virginia, United States

Sentara Careplex Hospital

Newport News, Virginia, United States

University of Washington

Seattle, Washington, United States

University of Wisconsin

Madison, Wisconsin, United States

Newcastle Melanoma Unit

Newcastle, New South Wales, Australia

Melanoma Institute Australia

Sydney, New South Wales, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Alfred Hospital

East Hawthorn, Victoria, Australia

Peter MacCallum Cancer Centre

East Melbourne, Victoria, Australia

Tom Baker Cancer Center

Calgary, Alberta, Canada

Sunnybrook Health Sciences Center

Toronto, Ontario, Canada

Helsinki Unversity Hospital

Helsinki, , Finland

U. Hosp. Schleswig-Holstein/Campus Lubeck

Lübeck, , Germany

City Hospital of Nurnberg

Nuremberg, , Germany

University of Wurzburg

Würzburg, , Germany

Tel-Aviv Sourasky Medical Center

Tel Aviv, , Israel

Istituto Europeo di Oncologia

Milan, , Italy

Istituto Nazionale dei Tumori Napoli

Naples, , Italy

Istituto Oncologico Veneto - University of Padova

Padua, , Italy

Padua University - Clinica Chirurgica II

Padua, , Italy

Netherlands Cancer Institute

Amsterdam, , Netherlands

Universitair Medisch Centrum Groningen

Groningen, , Netherlands

Hospital Clinic Barcelona

Barcelona, , Spain

Swedish Melanoma Study Group

Lund, , Sweden

Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

University of Zurich

Zurich, , Switzerland

Norfolk and Norwich University Hospital

Norfolk, Norwich, United Kingdom

Saint Thomas's Hospital

London, , United Kingdom

Countries

United States; Australia; Canada; Finland; Germany; Israel; Italy; Netherlands; Spain; Sweden; Switzerland; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 35921122 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28591523 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Related Links

https://www.saintjohnscancer.org/clinical-trials/

John Wayne Cancer Institute Clinical Trials (sponsor)

Other Identifiers

P01CA029605

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01CA189163

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MSLT-II

Identifier Type: -

Identifier Source: org_study_id

NCT00389571

Identifier Type: -

Identifier Source: nct_alias