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)
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ClinicalTrials.gov Identifier: NCT02434107 |
Recruitment Status :
Completed
First Posted : May 5, 2015
Last Update Posted : December 21, 2022
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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) |
Actual Enrollment : | 483 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Primary Completion Date : | December 2017 |
Actual Study Completion Date : | December 2017 |
Arm | Intervention/treatment |
---|---|
Experimental: Completion Lymphadenectomy
Completion Lymphadenectomy and monitoring afterwards
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Procedure: Completion Lymphadenectomy |
Experimental: Clinical Monitoring (Palpation and node ultrasound)
Monitoring only
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Procedure: Clinical Monitoring (Palpation and node ultrasound) |
- Distant metastases free survival [ Time Frame: 3 Years ]
- Distant metastases free survival [ Time Frame: 5 Years ]
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Cutaneous melanoma with a tumour thickness of at least 1,00mm
- Positive sentinel node with micro metastases of max. 2mm in diameter
Exclusion Criteria:
- Mucosal or ocular melanoma
- Cutaneous melanoma located in the head/neck region
- Evidence of satellite, in transit or local metastases / recurrences
- Macro metastases of the SN or micro metastases of >2mm in diameter
- Additional immune-suppressive therapy
- Pregnant of lactating women
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 |
Responsible Party: | University Hospital Tuebingen |
ClinicalTrials.gov Identifier: | NCT02434107 |
Other Study ID Numbers: |
V1410112004 |
First Posted: | May 5, 2015 Key Record Dates |
Last Update Posted: | December 21, 2022 |
Last Verified: | May 2017 |
Sentinel Lymph Node Biopsy Lymph Node Excision |
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Nerve Tissue Nevi and Melanomas Skin Neoplasms Neoplasms by Site Skin Diseases |