Trial record 2 of 2 for:    Multicenter Selective Lymphadenectomy Trial

Multicenter Selective Lymphadenectomy Trial (MSLT)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
John Wayne Cancer Institute
ClinicalTrials.gov Identifier:
NCT00275496
First received: January 10, 2006
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Melanoma
Procedure: Sentinel Lymph Node Dissection
Procedure: Complete Lymph Node Dissection
Procedure: Wide Excision
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by John Wayne Cancer Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 2001
Study Start Date: November 1993
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: WEX only Procedure: Wide Excision
Subject has wide excision only for primary melanoma.
Active Comparator: WEX + SLND Procedure: Sentinel Lymph Node Dissection
Subject has wide excision and sentinel lymph node dissection for primary melanoma.
Active Comparator: WEX+SLND+CLND 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00275496

Sponsors and Collaborators
John Wayne Cancer Institute
Investigators
Study Chair: Donald L Morton, MD John Wayne Cancer Institute
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John Wayne Cancer Institute
ClinicalTrials.gov Identifier: NCT00275496     History of Changes
Other Study ID Numbers: MSLT-1, NIH P01 CA029605
Study First Received: January 10, 2006
Last Updated: May 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by John Wayne Cancer Institute:
SLND
Sentinel
Melanoma
Surgical

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on September 18, 2014