MelanomaNCT00297895
Multicenter Selective Lymphadenectomy Trial II (MSLT-II)
A study testing Completion Lymphadenectomy and Monitoring with nodal ultrasound in people with Melanoma, run by Saint John's Cancer Institute at 63 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Melanoma
- What is being tested?
- Completion Lymphadenectomy and Monitoring with nodal ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,939 participants
- Where
- 63 sitesin 12 countries
- Study dates
- 30 Sep 2004to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
- SLND pathology shows, on microscopic examination, that melanoma extends through the lymph node capsule into the adjacent soft tissue.
Trial locations and contacts
63 sites in 12 countries.
63 sites in 12 countries
United States39 sites
University of Michigan
Ann Arbor, Michigan, 48109-0932
Mercy Medical Center
Baltimore, Maryland, 21202
Johns Hopkins Medical Institute
Baltimore, Maryland, 21287
St. Luke's Hospital
Bethlehem, Pennsylvania, 18015
Buffalo General Hospital
Buffalo, New York, 14209
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
University of Virginia
Charlottesville, Virginia, 22908
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Rush University
Chicago, Illinois, 60612-3824
University of Cincinnati
Cincinnati, Ohio, 45219
Memorial Hospital - Colorado Springs
Colorado Springs, Colorado, 809030-3658
Ohio State University
Columbus, Ohio, 43210
Dallas Surgical Group
Dallas, Texas, 75235
Geisinger Clinic
Danville, Pennsylvania, 17822
Duke University Medical Center
Durham, North Carolina, 27710
Feinstein Institute for Medical Research
Great Neck, New York, 11021
Greenville Hospital System Cancer Center
Greenville, South Carolina, 29605
Pennsylvania State Hershey Cancer Institute
Hershey, Pennsylvania, 17033
MD Anderson Cancer Center
Houston, Texas, 77030
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
Lakeland Regional Cancer Center
Lakeland, Florida, 33805
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Louisville
Louisville, Kentucky, 40202
University of Wisconsin
Madison, Wisconsin, 53792
Vanderbilt University
Nashville, Tennessee, 37232-6868
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Sentara Careplex Hospital
Newport News, Virginia, 23606
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
IHC Cancer Services Intermountain Medical Center
Salt Lake City, Utah, 84103
Hunstman Cancer Institute
Salt Lake City, Utah, 84112
Sharp Hospital
San Diego, California, 92123
John Wayne Cancer Institute
Santa Monica, California, 90404
University of Washington
Seattle, Washington, 98195
St. Louis University
St Louis, Missouri, 63110-8566
SUNY at Stony Brook Hospital Medical Center
Stony Brook, New York, 11794-8191
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612-9497
Wake Forest University
Winston-Salem, North Carolina, 27157
Main Line Surgeons
Wynnewood, Pennsylvania, 19096
Australia5 sites
Alfred Hospital
East Hawthorn, Victoria, 3123
Peter MacCallum Cancer Centre
East Melbourne, Victoria, 3677
Newcastle Melanoma Unit
Newcastle, New South Wales, 2298
Melanoma Institute Australia
Sydney, New South Wales, 2060
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Italy4 sites
Istituto Europeo di Oncologia
Milan, 20141
Istituto Nazionale dei Tumori Napoli
Naples, 80121
Istituto Oncologico Veneto - University of Padova
Padova, 35128
Padua University - Clinica Chirurgica II
Padua, 35128
Germany3 sites
U. Hosp. Schleswig-Holstein/Campus Lubeck
Lübeck, 23538
City Hospital of Nurnberg
Nuremberg, 90419
University of Wurzburg
Würzburg, 97080
Canada2 sites
Tom Baker Cancer Center
Calgary, Alberta, T2N 4N1
Sunnybrook Health Sciences Center
Toronto, Ontario, M4N3M5
Netherlands2 sites
Netherlands Cancer Institute
Amsterdam, 1066 CX
Universitair Medisch Centrum Groningen
Groningen, 9700 RB
Switzerland2 sites
Centre Hospitalier Universitaire Vaudois
Lausanne, CH 1011
University of Zurich
Zurich, CH-8091
United Kingdom2 sites
Saint Thomas's Hospital
London, SE17EH
Norfolk and Norwich University Hospital
Norfolk, Norwich, NR4 7UY
About this study
Official title: A Phase III Multicenter Randomized Trial of Sentinel Lymphadenectomy and Complete Lymph Node Dissection Versus Sentinel Lymphadenectomy Alone in Cutaneous Melanoma Patients With Molecular or Histopathological Evidence of Metastases in the Sentinel Node
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
- Being tested
- Completion Lymphadenectomy, Monitoring with nodal ultrasound
- Keywords
- sentinel lymph node dissection, complete lymph node dissection, surgical
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Completion LymphadenectomyProcedure or surgery
complete lymph node dissection of lymph node basin with positive node
Monitoring with nodal ultrasoundProcedure or surgery
serial ultrasound monitoring of SLND positive basin. If recurrence detected, subject has CLND.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound observation + delayed CLND if recurrence detected | Active comparator | Not described Receives: Procedure: Monitoring with nodal ultrasound |
| CLND | Active comparator | Not described Receives: Procedure: Completion Lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Secondary outcomes (2)
Disease-free survival over 10 years of follow up
Measured: 10 years
Recurrence during 10 years of follow up
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2006 (estimated)
- Study start30 Sep 2004
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,939 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint John's Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Richard Essner, M.D., Principal investigator, Saint John's Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00297895
- Sponsor's protocol ID
- MSLT-II
- Other IDs
- P01CA029605, R01CA189163
- Status last verified
- May 2022
- First submitted
- 27 Feb 2006
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35921122Faries 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.
PubMed 28591523
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Multicenter Randomized Trial of Sentinel Lymphadenectomy and Complete Lymph Node Dissection Versus Sentinel Lymphadenectomy Alone in Cutaneous Melanoma Patients With Molecular or Histopathological Evidence of Metastases in the Sentinel Node
- ClinicalTrials.gov ID
- NCT00297895
- Acronym / sponsor ID
- MSLT-II
- Conditions
- Melanoma
- Keywords
- sentinel lymph node dissection, complete lymph node dissection, surgical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,939 participants (actual)
- Lead sponsor
- Saint John's Cancer InstituteUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 30 Sep 2004 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 1 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound observation + delayed CLND if recurrence detected | Active comparator | Procedure: Monitoring with nodal ultrasound |
| CLND | Active comparator | Procedure: Completion Lymphadenectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Completion Lymphadenectomycomplete lymph node dissection of lymph node basin with positive node | Procedure or surgery | CLND |
| Monitoring with nodal ultrasoundserial ultrasound monitoring of SLND positive basin. If recurrence detected, subject has CLND. | Procedure or surgery | Ultrasound observation + delayed CLND if recurrence detected |
Primary outcome
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.
Time frame: 10 years
2 secondary outcomes
Disease-free survival over 10 years of follow up
Time frame: 10 years
Recurrence during 10 years of follow up
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Derived from this study: PubMed 35921122Multicenter 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.
- Derived from this study: PubMed 28591523Faries 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.
- John Wayne Cancer Institute Clinical Trials (sponsor)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Essner, M.D. principal investigator
Saint John's Cancer Institute
63 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Completion Lymphadenectomy and Monitoring with nodal ultrasound in people with Melanoma, run by Saint John's Cancer Institute at 63 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 sites in United States, Australia, Italy, Germany, Canada and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00297895, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2022.