Trials / Completed
CompletedNCT00297895
Multicenter Selective Lymphadenectomy Trial II (MSLT-II)
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,939 (actual)
- Sponsor
- Saint John's Cancer Institute · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Completion Lymphadenectomy | complete lymph node dissection of lymph node basin with positive node |
| PROCEDURE | Monitoring with nodal ultrasound | serial ultrasound monitoring of SLND positive basin. If recurrence detected, subject has CLND. |
Timeline
- Start date
- 2004-09-30
- Primary completion
- 2019-09-30
- Completion
- 2019-09-30
- First posted
- 2006-03-01
- Last updated
- 2022-05-13
Locations
63 sites across 12 countries: United States, Australia, Canada, Finland, Germany, Israel, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT00297895. Inclusion in this directory is not an endorsement.