Complete Lymph Node Dissection vs Watchful Waiting in Patients With Malignant Melanoma (Thickness of 1,0mm+ and Evidence of Metastases in the Sentinel Node) (DeCOG-SLT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02434107|
Recruitment Status : Unknown
Verified May 2017 by University Hospital Tuebingen.
Recruitment status was: Active, not recruiting
First Posted : May 5, 2015
Last Update Posted : May 5, 2017
Sentinel lymph node biopsy (SLNB) is considered as standard diagnostic procedure in melanoma patients carrying a reasonable risk for metastases. In numerous studies the prognostic role of micro metastases in the sentinel node (SN) was described. However, the prognostic value of a complete lymph node dissection in patients with a positive SN is still unclear.
This study was planned to analyse the survival outcome of patients with a positive SN receiving complete lymphadenectomy versus watchful waiting.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Procedure: Completion Lymphadenectomy Procedure: Clinical Monitoring (Palpation and node ultrasound)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||558 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Controlled and Prospective Randomised Study to Compare Complete Lymph Node Dissection Versus Watchful Waiting in Patients With Malignant Melanoma With a Tumour Thickness of 1,0mm+ and Evidence of Metastases in the Sentinel Node|
|Actual Study Start Date :||December 2005|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||December 2020|
Experimental: Completion Lymphadenectomy
Completion Lymphadenectomy and monitoring afterwards
Procedure: Completion Lymphadenectomy
Experimental: Clinical Monitoring (Palpation and node ultrasound)
Procedure: Clinical Monitoring (Palpation and node ultrasound)
- Distant metastases free survival [ Time Frame: 3 Years ]
- Distant metastases free survival [ Time Frame: 5 Years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02434107
|Study Director:||Claus Garbe, MD||University Hopsital Tübingen|
|Study Chair:||Rudolf Stadler, MD||Johannes Wesling Klinikum Minden|