Multicenter Selective Lymphadenectomy Trial II (MSLT-II) | Not Recruiting
Multicenter Selective Lymphadenectomy Trial II (MSLT-II)

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Melanoma
Unfortunately contact details are not available for this trial.
Primary Contact Details
Not Recruiting
Recruitment Status
Primary Trial ID Number
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.
Research Details
    Sorry, this information is not available
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Procedure : Completion Lymphadenectomy, Procedure : Monitoring with nodal ultrasound

Study Arm Groups : CLND, Ultrasound observation + delayed CLND if recurrence detected

Intervention Type
See Interventions above
Primary Outcome Measures
  • 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 Outcome Measures
  • Disease-free survival over 10 years of follow up; 10 years; Recurrence during 10 years of follow up; 10 years
Sorry, this information is not available
Result Reports
This is available on the website
Age Range
18 Years - 75 Years
Who Can Participate
Number of Participants
Participant Inclusion 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.
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Site: GB44006
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Australia, Canada, Finland, Germany, Israel, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom, United States
Scientific 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
EudraCT Number
Not available for this trial
  • National Institutes of Health (NIH)
  • National Cancer Institute (NCI)
Other Study ID Numbers
John Wayne Cancer Institute
Key Dates

Recruitment Start Date

Sep 2004

Recruitment End Date

Sep 2022

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

27 Feb 2006

Last Updated

02 Jan 2015