Multicenter Selective Lymphadenectomy Trial II (MSLT-II) | Not Recruiting
Multicenter Selective Lymphadenectomy Trial II (MSLT-II)
Health Conditions
  • Melanoma
Not Recruiting
Recruitment Status
NCT00297895
Primary Trial ID Number
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.
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
Research Question
  • 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.
Design Type
Sorry, this information is not available
Ethics Approval
Sorry, this information is not available
Publications
Sorry, this information is not available
Countries of Recruitment
United States; Australia; Canada; Finland; Germany; Israel; Italy; Netherlands; Spain; Sweden; Switzerland; United Kingdom
Participant Sex
Both
Participant Age Range
18 Years to 75 Years
Participant Type
Sorry, this information is not available
Trial Sample Size
1925
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
  • 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.
Interventions
Procedure; Completion Lymphadenectomy; complete lymph node dissection of lymph node basin with positive node; [CLND]; Procedure; Monitoring with nodal ultrasound; serial ultrasound monitoring of SLND positive basin. If recurrence detected, subject has CLND.; [Ultrasound observation + delayed CLND if recurrence detected]
Design Details
Sorry, this information is not available
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Results Reporting
Sorry, this information is not available
Acronym
Sorry, this information is not available
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
Secondary Trial Identifying Number
P01CA029605; R01CA189163
Website
http://www.jwci.org/open-trials.aspx
Study Funded By
John Wayne Cancer Institute
Funder Type
Sorry, this information is not available
Study Sponsored By
John Wayne Cancer Institute
Study Also Sponsored By
National Institutes of Health (NIH); National Cancer Institute (NCI)
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

27 Feb 2006

Last Updated

02 Jan 2015

Date Record Refreshed on UKCTG

01 Aug 2015