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Multicenter Selective Lymphadenectomy Trial (MSLT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00275496
Recruitment Status : Completed
First Posted : January 12, 2006
Last Update Posted : September 2, 2015
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
John Wayne Cancer Institute

Tracking Information
First Submitted Date  ICMJE January 10, 2006
First Posted Date  ICMJE January 12, 2006
Last Update Posted Date September 2, 2015
Study Start Date  ICMJE November 1993
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2009)
To determine whether wide excision of the primary with intraoperative lymphatic mapping (LM) followed by selective lymphadenectomy will effectively prolong overall survival compared to wide excision of the primary melanoma alone. [ Time Frame: 10 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 10, 2006)
To determine whether wide excision of the primary with intraoperative lymphatic mapping (LM) followed by selective lymphadenectomy will effectively prolong overall survival compared to wide excision of the primary melanoma alone.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2009)
Disease-free survival; Incidence, timing, and anatomic distribution of distant metastases; Morbidity of procedures; Significance of TA90 levels; Incidence of Sentinel Node Metastases (biopsy) vs clinical metastases (observation); Accuracy of LM [ Time Frame: 10 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2006)
Disease-free survival; Incidence, timing, and anatomic distribution of distant metastases; Morbidity of procedures; Significance of TA90 levels; Sentinel node metastases in WEX arm; Incidence of nodal metastases; Accuracy of LM
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multicenter Selective Lymphadenectomy Trial (MSLT)
Official Title  ICMJE A Clinical Study of Wide Excision Alone Versus Wide Excision With Intraoperative Lymphatic Mapping and Selective Lymph Node Dissection in the Treatment of Patients With Cutaneous Invasive Melanoma.
Brief Summary Subjects must be diagnosed with melanoma. All subjects receive Wide Excision (WEX) of their melanoma. If the melanoma meets study requirements, the subject is randomized to receive either (1) no further surgical procedures as part of the study or (2) a Selective Lymphadenectomy with the possibility of a Complete Lymphadenectomy. Subjects are then followed for 10 years.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Melanoma
Intervention  ICMJE
  • Procedure: Sentinel Lymph Node Dissection
    Subject has wide excision and sentinel lymph node dissection for primary melanoma.
  • Procedure: Complete Lymph Node Dissection
    Subject has wide excision, sentinel lymph node dissection, and complete lymph node dissection (if positive sentinel node found) for primary melanoma.
  • Procedure: Wide Excision
    Subject has wide excision only for primary melanoma.
Study Arms  ICMJE
  • Active Comparator: WEX only
    Intervention: Procedure: Wide Excision
  • Active Comparator: WEX + SLND
    Intervention: Procedure: Sentinel Lymph Node Dissection
  • Active Comparator: WEX+SLND+CLND
    Intervention: Procedure: Complete Lymph Node Dissection
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2006)
2001
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. The patient consents to be in the study.
  2. The patient must have invasive melanoma with: 1) Clark Level III and Breslow Thickness greater than or equal to 1.00 mm; or 2) Clark Level IV or V with any Breslow thickness. A confirmation of diagnosis and thickness must be made by the institutional pathologist.
  3. The primary cutaneous melanoma site must be on the head, neck, trunk, extremity, scalp, palm of the hand, sole of the foot, or subungual skin.
  4. The patient's biopsy must have been completed no more than 10 weeks before the initial visit to the clinic. (Surgery must be scheduled within three months of the biopsy.)
  5. The patient must be between 18 and 75 years old.
  6. The patient must have a life expectancy of at least 10 years from the time of diagnosis, excluding the diagnosis of melanoma.

Exclusion Criteria:

  1. The patient had a prior wide excision of the primary with a diameter of excision greater than or equal to 3.0 cm and the shortest margin from the tumor edge to the excision edge was measured by a pathologist to be greater than or equal to 1.5 cm; or the patient had an elliptical excision and a margin beyond the tumor edge was greater than or equal to 1.5 cm at the narrowest margin.
  2. The primary cutaneous melanoma involves the eye, ear, mucous membranes.
  3. The patient has clinical evidence of satellite lesions, in-transit, regional nodal or distant metastases.
  4. The patient has a second primary invasive melanoma.
  5. The patient has had any type of solid tumor or hematologic malignancy during the past 5 years. Exceptions are if the patient has been treated for T1 lesions (e.g., squamous cell carcinoma of the skin, basal cell carcinoma or in situ carcinoma of the uterine cervix) during the past 5 years, but has not received treatment within the last 6 months.
  6. The patient has had prior skin grafts, tissue transfers or flaps, or lymph node dissections that may alter the lymphatic drainage pattern from a primary cutaneous melanoma to the adjacent regional lymph node basins.
  7. The patient has had previous chemotherapy, immunotherapy or radiation therapy.
  8. The patient has had an organ transplantation and is receiving immunosuppressive agents as a result of the transplantation.
  9. The patient has taken oral or parenteral steroids or immunosuppressive drugs within the last 6 months.
  10. The patient has any known primary or secondary immune deficiencies.
  11. The patient has another medical condition that will affect life expectancy.
  12. The patient is pregnant.
  13. Evidence that the patient cannot undergo selective lymph node dissection for any reason.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00275496
Other Study ID Numbers  ICMJE MSLT-1
NIH P01 CA029605
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party John Wayne Cancer Institute
Study Sponsor  ICMJE John Wayne Cancer Institute
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE
Study Chair: Donald L Morton, MD John Wayne Cancer Institute
PRS Account John Wayne Cancer Institute
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP