Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000347561
Ethics application status
Approved
Date submitted
25/11/2004
Date registered
25/11/2004
Date last updated
18/05/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Multicenter Selective Lymphadenectomy Trial II (MSLT-II)
Scientific title
A Phase III Multicenter Randomized Trial of Sentinel Lymphadenectomy followed by Serial Nodal Ultrasound versus Sentinel Lymphadenectomy followed by Complete Lymphadenectomy in Cutaneous Melanoma Patients with Molecular or Histopathological Evidence of Metastases in the Sentinel Node to Improve Melanoma Specific Survival.
Secondary ID [1] 60 0
National Clinical Trials Registry: NCTR563
Universal Trial Number (UTN)
Trial acronym
MLST II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 56 0
Condition category
Condition code
Cancer 64 64 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1: Complete lymph node dissection + ten years of follow up
Group 2: Observation with serial nodal ultrasound for first five years of ten years of follow up
Intervention code [1] 1091 0
Treatment: Surgery
Comparator / control treatment
Follow up with nodal ultrasound
Control group
Active

Outcomes
Primary outcome [1] 95 0
The primary endpoint is melanoma-specific survival. This is defined as the time between the date of a subject’s randomization (or date of complete lymph node dissection (CLND) for those randomized to the complete lymph node dissection arm) and the date of a subject’s death due to melanoma.
Timepoint [1] 95 0
All subjects are followed until death, or at least 10 years. Follow up intervals are every four months for the first 2 years, every six months during years 3-5, and annually during years 6-10.
Secondary outcome [1] 192 0
Disease free survival and time to recurrence.
Timepoint [1] 192 0
Disease-free survival 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 a subject’s diagnosis of first recurrence after randomization. Recurrence is defined as the diagnosis of new sites of melanoma. The time to recurrence is the date at which recurrence is documented. Only the date on which a recurrence was confirmed will be used as a recurrence date. Every recurrence will be sub-classified according to size and location.

Eligibility
Key inclusion criteria
Subjects must meet all of the following criteria to be eligible to randomize in this trial.1) Ability to provide informed consent. 2) Have a primary melanoma that is cutaneous (including head, neck, trunk, extremity, scalp, palm, sole, subungual skin tissues). 3) Have clear margins following wide local excision. 4) ECOG performance status 0-1. 5) Life expectancy of at least 10 years from the time of diagnosis, not considering the melanoma in question, as determined by the PI. 6) Willing to return to the MSLT-II center for follow up examinations and procedures as outlined in the protocol. 7) Randomization and/or complete lymph node dissection (as appropriate to randomization arm) must be completed no more than 120 days following the diagnostic biopsy of the primary melanoma. 8) Have a melanoma-related tumor-positive SN, determined by either of the following methods:a. 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).b. Diagnosis of tumor-positive SN by RT-PCR analysis performed at JWCI, provided the primary melanoma fits into one of the following categories:o Breslow thickness of 1.20 mm or greater and Clark Level IIIo Clark Level IV or V, regardless of Breslow thicknesso Ulceration, regardless of Breslow thickness or Clark level. 9) Subjects must be male or female.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects cannot meet any of the following criteria in order to be eligible to randomize in this trial.1) History of previous or concurrent (i.e., second primary) invasive melanoma.2) Primary melanoma of the eye, ears, mucous membranes or internal viscera.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 experimental protocols or alternative therapies that might confound the analysis of this trial. Adjuvant therapy protocols after recurrence are acceptable.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random permuted variable size block design
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Bio-equivalence
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/09/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1925
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,QLD
Recruitment outside Australia
Country [1] 326 0
United States of America
State/province [1] 326 0

Funding & Sponsors
Funding source category [1] 95 0
Government body
Name [1] 95 0
National Cancer Institute (NCI) grant PO1 CA29605-12
Country [1] 95 0
United States of America
Primary sponsor type
Charities/Societies/Foundations
Name
John Wayne Cancer Institute
Address
2200 Santa Monica Blvd.
Santa Monica, CA 90404
Country
United States of America
Secondary sponsor category [1] 72 0
None
Name [1] 72 0
Nil
Address [1] 72 0
Country [1] 72 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 628 0
City Hospital of Nurnberg
Ethics committee address [1] 628 0
Ethics committee country [1] 628 0
Germany
Date submitted for ethics approval [1] 628 0
Approval date [1] 628 0
06/09/2005
Ethics approval number [1] 628 0
Ethics committee name [2] 629 0
Dallas Surgical Group
Ethics committee address [2] 629 0
Ethics committee country [2] 629 0
United States of America
Date submitted for ethics approval [2] 629 0
Approval date [2] 629 0
20/04/2006
Ethics approval number [2] 629 0
Ethics committee name [3] 630 0
Greenville Hospital System Cancer Center
Ethics committee address [3] 630 0
Ethics committee country [3] 630 0
United States of America
Date submitted for ethics approval [3] 630 0
Approval date [3] 630 0
16/05/2006
Ethics approval number [3] 630 0
Ethics committee name [4] 631 0
H.Lee Moffitt Cancer Center
Ethics committee address [4] 631 0
Ethics committee country [4] 631 0
United States of America
Date submitted for ethics approval [4] 631 0
Approval date [4] 631 0
17/01/2006
Ethics approval number [4] 631 0
Ethics committee name [5] 632 0
Hatton Institute of Research
Ethics committee address [5] 632 0
Ethics committee country [5] 632 0
United States of America
Date submitted for ethics approval [5] 632 0
Approval date [5] 632 0
26/05/2006
Ethics approval number [5] 632 0
Ethics committee name [6] 633 0
Helsinki University Hospital
Ethics committee address [6] 633 0
Ethics committee country [6] 633 0
Finland
Date submitted for ethics approval [6] 633 0
Approval date [6] 633 0
03/01/2006
Ethics approval number [6] 633 0
Ethics committee name [7] 634 0
Huntsman Cancer Institute
Ethics committee address [7] 634 0
Ethics committee country [7] 634 0
United States of America
Date submitted for ethics approval [7] 634 0
Approval date [7] 634 0
19/07/2006
Ethics approval number [7] 634 0
Ethics committee name [8] 635 0
IHC Cancer Services - LDS Hospital
Ethics committee address [8] 635 0
Ethics committee country [8] 635 0
United States of America
Date submitted for ethics approval [8] 635 0
Approval date [8] 635 0
27/10/2005
Ethics approval number [8] 635 0
Ethics committee name [9] 636 0
Istituto Europeo di Oncologia
Ethics committee address [9] 636 0
Ethics committee country [9] 636 0
Italy
Date submitted for ethics approval [9] 636 0
Approval date [9] 636 0
07/07/2005
Ethics approval number [9] 636 0
Ethics committee name [10] 637 0
Istituto Nazionale Tumori Napoli
Ethics committee address [10] 637 0
Ethics committee country [10] 637 0
Italy
Date submitted for ethics approval [10] 637 0
Approval date [10] 637 0
27/10/2004
Ethics approval number [10] 637 0
Ethics committee name [11] 638 0
John Wayne Cancer Institute
Ethics committee address [11] 638 0
Ethics committee country [11] 638 0
United States of America
Date submitted for ethics approval [11] 638 0
Approval date [11] 638 0
07/09/2004
Ethics approval number [11] 638 0
MORD-LM/SL-CLND-1102
Ethics committee name [12] 639 0
Lakeland Regional Cancer Center
Ethics committee address [12] 639 0
Ethics committee country [12] 639 0
United States of America
Date submitted for ethics approval [12] 639 0
Approval date [12] 639 0
16/09/2005
Ethics approval number [12] 639 0
Ethics committee name [13] 640 0
Main Line Surgeons
Ethics committee address [13] 640 0
Ethics committee country [13] 640 0
United States of America
Date submitted for ethics approval [13] 640 0
Approval date [13] 640 0
24/04/2006
Ethics approval number [13] 640 0
Ethics committee name [14] 641 0
Memorial Hospital - Colorado Springs
Ethics committee address [14] 641 0
Ethics committee country [14] 641 0
United States of America
Date submitted for ethics approval [14] 641 0
Approval date [14] 641 0
21/03/2006
Ethics approval number [14] 641 0
Ethics committee name [15] 642 0
Millard Fillmore Hospital
Ethics committee address [15] 642 0
Ethics committee country [15] 642 0
United States of America
Date submitted for ethics approval [15] 642 0
Approval date [15] 642 0
22/09/2005
Ethics approval number [15] 642 0
Ethics committee name [16] 643 0
Newcastle Melanoma Unit
Ethics committee address [16] 643 0
Ethics committee country [16] 643 0
Australia
Date submitted for ethics approval [16] 643 0
Approval date [16] 643 0
04/05/2005
Ethics approval number [16] 643 0
Ethics committee name [17] 644 0
OSF Saint Francis Medical Center
Ethics committee address [17] 644 0
Ethics committee country [17] 644 0
United States of America
Date submitted for ethics approval [17] 644 0
Approval date [17] 644 0
13/09/2005
Ethics approval number [17] 644 0
Ethics committee name [18] 645 0
Padua University - Clinica Chirurgica II
Ethics committee address [18] 645 0
Ethics committee country [18] 645 0
Italy
Date submitted for ethics approval [18] 645 0
Approval date [18] 645 0
10/10/2005
Ethics approval number [18] 645 0
Ethics committee name [19] 646 0
Princess Alexandra Hospital
Ethics committee address [19] 646 0
Ethics committee country [19] 646 0
Australia
Date submitted for ethics approval [19] 646 0
Approval date [19] 646 0
27/10/2005
Ethics approval number [19] 646 0
Ethics committee name [20] 647 0
Roswell Park Cancer Institute
Ethics committee address [20] 647 0
Ethics committee country [20] 647 0
United States of America
Date submitted for ethics approval [20] 647 0
Approval date [20] 647 0
15/03/2006
Ethics approval number [20] 647 0
Ethics committee name [21] 648 0
Sharp Hospital
Ethics committee address [21] 648 0
Ethics committee country [21] 648 0
United States of America
Date submitted for ethics approval [21] 648 0
Approval date [21] 648 0
14/12/2005
Ethics approval number [21] 648 0
Ethics committee name [22] 649 0
St. Louis University
Ethics committee address [22] 649 0
Ethics committee country [22] 649 0
United States of America
Date submitted for ethics approval [22] 649 0
Approval date [22] 649 0
20/09/2005
Ethics approval number [22] 649 0
Ethics committee name [23] 650 0
St. Luke's Hospital
Ethics committee address [23] 650 0
Ethics committee country [23] 650 0
United States of America
Date submitted for ethics approval [23] 650 0
Approval date [23] 650 0
03/04/2006
Ethics approval number [23] 650 0
Ethics committee name [24] 651 0
Swedish Melanoma Study Group
Ethics committee address [24] 651 0
Ethics committee country [24] 651 0
Sweden
Date submitted for ethics approval [24] 651 0
Approval date [24] 651 0
01/12/2005
Ethics approval number [24] 651 0
Ethics committee name [25] 652 0
Sydney Melanoma Unit
Ethics committee address [25] 652 0
Ethics committee country [25] 652 0
Australia
Date submitted for ethics approval [25] 652 0
Approval date [25] 652 0
07/10/2004
Ethics approval number [25] 652 0
Ethics committee name [26] 653 0
Tel-Aviv Sourasky Medical Center
Ethics committee address [26] 653 0
Ethics committee country [26] 653 0
Israel
Date submitted for ethics approval [26] 653 0
Approval date [26] 653 0
26/11/2004
Ethics approval number [26] 653 0
Ethics committee name [27] 654 0
Tom Baker Cancer Centre
Ethics committee address [27] 654 0
Ethics committee country [27] 654 0
Canada
Date submitted for ethics approval [27] 654 0
Approval date [27] 654 0
30/11/2005
Ethics approval number [27] 654 0
Ethics committee name [28] 655 0
Universitair Medisch Centrum Groningen
Ethics committee address [28] 655 0
Ethics committee country [28] 655 0
Netherlands
Date submitted for ethics approval [28] 655 0
Approval date [28] 655 0
08/03/2005
Ethics approval number [28] 655 0
Ethics committee name [29] 656 0
University of Cincinnati
Ethics committee address [29] 656 0
Ethics committee country [29] 656 0
United States of America
Date submitted for ethics approval [29] 656 0
Approval date [29] 656 0
29/09/2004
Ethics approval number [29] 656 0
Ethics committee name [30] 657 0
University of Louisville
Ethics committee address [30] 657 0
Ethics committee country [30] 657 0
United States of America
Date submitted for ethics approval [30] 657 0
Approval date [30] 657 0
02/12/2005
Ethics approval number [30] 657 0
Ethics committee name [31] 658 0
University of Texas Southwestern
Ethics committee address [31] 658 0
Ethics committee country [31] 658 0
United States of America
Date submitted for ethics approval [31] 658 0
Approval date [31] 658 0
08/11/2005
Ethics approval number [31] 658 0
Ethics committee name [32] 659 0
University of Wurzburg
Ethics committee address [32] 659 0
Ethics committee country [32] 659 0
Germany
Date submitted for ethics approval [32] 659 0
Approval date [32] 659 0
08/05/2006
Ethics approval number [32] 659 0
Ethics committee name [33] 660 0
Vanderbilt University
Ethics committee address [33] 660 0
Ethics committee country [33] 660 0
United States of America
Date submitted for ethics approval [33] 660 0
Approval date [33] 660 0
01/03/2006
Ethics approval number [33] 660 0
Ethics committee name [34] 661 0
Wake Forest University
Ethics committee address [34] 661 0
Ethics committee country [34] 661 0
United States of America
Date submitted for ethics approval [34] 661 0
Approval date [34] 661 0
07/12/2005
Ethics approval number [34] 661 0
Ethics committee name [35] 662 0
Westmead Hospital
Ethics committee address [35] 662 0
Ethics committee country [35] 662 0
Australia
Date submitted for ethics approval [35] 662 0
Approval date [35] 662 0
30/08/2005
Ethics approval number [35] 662 0

Summary
Brief summary
The study is being conducted to prove/disprove the hypothesis that Sentinel Lymphadenectomy plus 5 years of serial nodal ultrasound is as effective as Sentinel Lymphadenectomy plus Complete Lymphadenectomy in prolonging disease free survival in patients with metastasis to the sentinel node. This trial is unblinded.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35739 0
Address 35739 0
Country 35739 0
Phone 35739 0
Fax 35739 0
Email 35739 0
Contact person for public queries
Name 10280 0
Lisa van Kreuningen
Address 10280 0
John Wayne Cancer Institute
2200 Santa Monica Blvd
Santa Monica CA 90404
Country 10280 0
United States of America
Phone 10280 0
+1 310 582 7053
Fax 10280 0
+1 310 998 3996
Email 10280 0
lvk@jwci.org
Contact person for scientific queries
Name 1208 0
Dr. Donald L. Morton
Address 1208 0
John Wayne Cancer Institute
2200 Santa Monica Blvd.
Santa Monica CA 90404
Country 1208 0
United States of America
Phone 1208 0
+1 310 829 8781
Fax 1208 0
Email 1208 0
mortond@jwci.org

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

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