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MelanomaPhase 3NCT00275496

Multicenter Selective Lymphadenectomy Trial (MSLT)

A Phase 3 study testing Sentinel Lymph Node Dissection, Complete Lymph Node Dissection and Wide Excision in people with Melanoma, run by Saint John's Cancer Institute.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Melanoma
What is being tested?
Sentinel Lymph Node Dissection, Complete Lymph Node Dissection and Wide Excision
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,001 participants
Where
No sites listed yet
Study dates
Nov 1993to Jun 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient consents to be in the study.
  • 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.
  • 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.
  • 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.)
  • The patient must be between 18 and 75 years old.
  • The patient must have a life expectancy of at least 10 years from the time of diagnosis, excluding the diagnosis of melanoma.

Who cannot join

  • 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.
  • The primary cutaneous melanoma involves the eye, ear, mucous membranes.
  • The patient has clinical evidence of satellite lesions, in-transit, regional nodal or distant metastases.
  • The patient has a second primary invasive melanoma.
  • 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.
  • 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.
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  • The patient has had previous chemotherapy, immunotherapy or radiation therapy.
  • The patient has had an organ transplantation and is receiving immunosuppressive agents as a result of the transplantation.
  • The patient has taken oral or parenteral steroids or immunosuppressive drugs within the last 6 months.
  • The patient has any known primary or secondary immune deficiencies.
  • The patient has another medical condition that will affect life expectancy.
  • The patient is pregnant.
  • Evidence that the patient cannot undergo selective lymph node dissection for any reason.

About this study

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.

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.

Conditions
Melanoma
Being tested
Sentinel Lymph Node Dissection, Complete Lymph Node Dissection, Wide Excision
Keywords
SLND, Sentinel, Melanoma, Surgical
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sentinel Lymph Node DissectionProcedure or surgery

    Subject has wide excision and sentinel lymph node dissection for primary melanoma.

  • Complete Lymph Node DissectionProcedure or surgery

    Subject has wide excision, sentinel lymph node dissection, and complete lymph node dissection (if positive sentinel node found) for primary melanoma.

  • Wide ExcisionProcedure or surgery

    Subject has wide excision only for primary melanoma.

Study groups in NCT00275496
Study groupRoleWhat they receive
WEX onlyActive comparatorNot described
Receives: Procedure: Wide Excision
WEX + SLNDActive comparatorNot described
Receives: Procedure: Sentinel Lymph Node Dissection
WEX+SLND+CLNDActive comparatorNot described
Receives: Procedure: Complete Lymph Node Dissection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 10 years

Secondary outcomes (1)

  1. 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

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2006 (estimated)
  2. Study startNov 1993
  3. Primary completionJun 2012
  4. Study completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,001 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00275496
Sponsor's protocol ID
MSLT-1
Other IDs
NIH P01 CA029605
Status last verified
May 2014
First submitted
10 Jan 2006
Last updated
2 Sep 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Morton DL, Thompson JF, Cochran AJ, Mozzillo N, Elashoff R, Essner R, Nieweg OE, Roses DF, Hoekstra HJ, Karakousis CP, Reintgen DS, Coventry BJ, Glass EC, Wang HJ; MSLT Group. Sentinel-node biopsy or nodal observation in melanoma. N Engl J Med. 2006 Sep 28;355(13):1307-17. doi: 10.1056/NEJMoa060992.

    PubMed 17005948

  • Faries MB, Thompson JF, Cochran A, Elashoff R, Glass EC, Mozzillo N, Nieweg OE, Roses DF, Hoekstra HJ, Karakousis CP, Reintgen DS, Coventry BJ, Wang HJ, Morton DL; MSLT Cooperative Group. The impact on morbidity and length of stay of early versus delayed complete lymphadenectomy in melanoma: results of the Multicenter Selective Lymphadenectomy Trial (I). Ann Surg Oncol. 2010 Dec;17(12):3324-9. doi: 10.1245/s10434-010-1203-0. Epub 2010 Jul 8.

    PubMed 20614193

  • Howard JH, Thompson JF, Mozzillo N, Nieweg OE, Hoekstra HJ, Roses DF, Sondak VK, Reintgen DS, Kashani-Sabet M, Karakousis CP, Coventry BJ, Kraybill WG, Smithers BM, Elashoff R, Stern SL, Cochran AJ, Faries MB, Morton DL. Metastasectomy for distant metastatic melanoma: analysis of data from the first Multicenter Selective Lymphadenectomy Trial (MSLT-I). Ann Surg Oncol. 2012 Aug;19(8):2547-55. doi: 10.1245/s10434-012-2398-z. Epub 2012 May 31.

    PubMed 22648554

  • Morton DL, Thompson JF, Cochran AJ, Mozzillo N, Nieweg OE, Roses DF, Hoekstra HJ, Karakousis CP, Puleo CA, Coventry BJ, Kashani-Sabet M, Smithers BM, Paul E, Kraybill WG, McKinnon JG, Wang HJ, Elashoff R, Faries MB; MSLT Group. Final trial report of sentinel-node biopsy versus nodal observation in melanoma. N Engl J Med. 2014 Feb 13;370(7):599-609. doi: 10.1056/NEJMoa1310460.

    PubMed 24521106

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sentinel Lymph Node Dissection, Complete Lymph Node Dissection and Wide Excision in people with Melanoma, run by Saint John's Cancer Institute.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00275496, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2015.

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