Multicenter Selective Lymphadenectomy Trial II (MSLT-II)
This study is currently recruiting participants.
Verified September 2012 by John Wayne Cancer Institute
Sponsor:
John Wayne Cancer Institute
Collaborator:
Information provided by (Responsible Party):
John Wayne Cancer Institute
ClinicalTrials.gov Identifier:
NCT00297895
First received: February 27, 2006
Last updated: September 10, 2012
Last verified: September 2012
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Purpose
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.
Condition | Intervention | Phase |
---|---|---|
Melanoma |
Procedure: Completion Lymphadenectomy Procedure: Monitoring with nodal ultrasound |
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 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 |
Resource links provided by NLM:
Further study details as provided by John Wayne Cancer Institute:
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. [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Disease-free survival over 10 years of follow up [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- Recurrence during 10 years of follow up [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Estimated Enrollment: | 1925 |
Study Start Date: | September 2004 |
Estimated Study Completion Date: | September 2022 |
Estimated Primary Completion Date: | September 2022 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Active Comparator: Ultrasound observation + delayed CLND if recurrence detected |
Procedure: Monitoring with nodal ultrasound
serial ultrasound monitoring of SLND positive basin. If recurrence detected, subject has CLND.
|
Active Comparator: CLND |
Procedure: Completion Lymphadenectomy
complete lymph node dissection of lymph node basin with positive node
|
Eligibility
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Ability to provide informed consent.
- Between 18 and 75 years of age.
- Have a primary melanoma that is cutaneous (including head, neck, trunk, extremity, scalp, palm, sole, subungual skin tissues).
- Have clear margins following WLE.
- ECOG performance status 0-1.
- Life expectancy of at least 10 years from the time of diagnosis, not considering the melanoma in question, as determined by the PI.
- Willing to return to the MSLT-II center for follow up examinations and procedures as outlined in the protocol.
- 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.
Have a melanoma-related tumor-positive SN, determined by either of the following methods:
- 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).
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:
- History of previous or concurrent (i.e., second primary) invasive melanoma.
- Primary melanoma of the eye, ears, mucous membranes or internal viscera.
- Physical, clinical, radiographic or pathologic evidence of satellite, in-transit, regional, or distant metastatic disease.
- 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.
- Skin grafts, tissue transfers or flaps that have the potential to alter the lymphatic drainage pattern from the primary melanoma to a LN basin.
- Allergy to vital blue dye or any radiocolloid.
- 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.)
- 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.
- 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).
- Melanoma-related operative procedures not corresponding to criteria described in the protocol.
- Primary or secondary immune deficiencies or known significant autoimmune disease.
- History of organ transplantation.
- Oral or parenteral immunosuppressive agents (not topical or inhaled steroids) at any time during study participation or within 6 months prior to enrollment.
- Pregnant or lactating women.
- Participation in concurrent experimental protocols or alternative therapies that might confound the analysis of this trial. Adjuvant therapy protocols after recurrence are acceptable.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00297895
Show 65 Study Locations
Contacts
Contact: Donald Morton, M.D. | 310-829-8363 | mortond@jwci.org |
Contact: Holly Hou | 310-582-7439 | houh@jwci.org |
Show 65 Study Locations
Sponsors and Collaborators
John Wayne Cancer Institute
Investigators
Study Chair: | Donald L. Morton, M.D. | John Wayne Cancer Institute |
More Information
Additional Information:
No publications provided
Keywords provided by John Wayne Cancer Institute:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 16, 2012
Additional Information:
No publications provided
Responsible Party: | John Wayne Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00297895 History of Changes |
Obsolete Identifiers: | NCT00389571 |
Other Study ID Numbers: | MSLT-II, NIH P01 CA029605 |
Study First Received: | February 27, 2006 |
Last Updated: | September 10, 2012 |
Health Authority: | United States: Institutional Review Board |
Keywords provided by John Wayne Cancer Institute:
sentinel lymph node dissection complete lymph node dissection 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 October 16, 2012