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

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Medical Conditions
  • Melanoma
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Not Recruiting
Trial source and source ID number
NCT00297895

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This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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.
Research Details
    Sorry, this information is not available
Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
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
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
18 Years - 75 Years
Who Can Participate
Patients
Number of Participants
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
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Norfolk and Norwich University Hospital
Norwich
NR4 7UY
1. St. Thomas' Hospital
London
SE17EH
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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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
Funder(s)
  • National Institutes of Health (NIH)
  • National Cancer Institute (NCI)
Other Study ID Numbers
MSLT-II
Sponsor(s)
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 added to source

27 Feb 2006

Date updated in source

01 Jun 2016