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)

• ClinicalTrials.gov Identifier: NCT02434107
• Recruitment Status: Completed
• First Posted: May 5, 2015
• Last Update Posted: December 21, 2022
• Sponsor: University Hospital Tuebingen
• Information provided by (Responsible Party): University Hospital Tuebingen

Tracking Information

• First Submitted Date: April 2, 2015
• First Posted Date: May 5, 2015
• Last Update Posted Date: December 21, 2022
• Actual Study Start Date: December 2005
• Actual Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 29, 2015): Distant metastases free survival [ Time Frame: 3 Years ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: April 29, 2015): Distant metastases free survival [ Time Frame: 5 Years ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Complete Lymph Node Dissection vs Watchful Waiting in Patients With Malignant Melanoma (Thickness of 1,0mm+ and Evidence of Metastases in the Sentinel Node)
• 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

Brief Summary

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Melanoma

Intervention

• Procedure: Completion Lymphadenectomy
• Procedure: Clinical Monitoring (Palpation and node ultrasound)

Study Arms

• Experimental: Completion Lymphadenectomy
  Completion Lymphadenectomy and monitoring afterwards
  Intervention: Procedure: Completion Lymphadenectomy
• Experimental: Clinical Monitoring (Palpation and node ultrasound)
  Monitoring only
  Intervention: Procedure: Clinical Monitoring (Palpation and node ultrasound)

Publications *

• Leiter U, Stadler R, Mauch C, Hohenberger W, Brockmeyer NH, Berking C, Sunderkotter C, Kaatz M, Schatton K, Lehmann P, Vogt T, Ulrich J, Herbst R, Gehring W, Simon JC, Keim U, Verver D, Martus P, Garbe C; German Dermatologic Cooperative Oncology Group. Final Analysis of DeCOG-SLT Trial: No Survival Benefit for Complete Lymph Node Dissection in Patients With Melanoma With Positive Sentinel Node. J Clin Oncol. 2019 Nov 10;37(32):3000-3008. doi: 10.1200/JCO.18.02306. Epub 2019 Sep 26.
• Leiter U, Stadler R, Mauch C, Hohenberger W, Brockmeyer N, Berking C, Sunderkotter C, Kaatz M, Schulte KW, Lehmann P, Vogt T, Ulrich J, Herbst R, Gehring W, Simon JC, Keim U, Martus P, Garbe C; German Dermatologic Cooperative Oncology Group (DeCOG). Complete lymph node dissection versus no dissection in patients with sentinel lymph node biopsy positive melanoma (DeCOG-SLT): a multicentre, randomised, phase 3 trial. Lancet Oncol. 2016 Jun;17(6):757-767. doi: 10.1016/S1470-2045(16)00141-8. Epub 2016 May 5.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 16, 2022): 483
• Original Estimated Enrollment (submitted: April 29, 2015): 558
• Actual Study Completion Date: December 2017
• Actual Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT02434107
• Other Study ID Numbers: V1410112004
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University Hospital Tuebingen
• Original Responsible Party: Same as current
• Current Study Sponsor: University Hospital Tuebingen
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Claus Garbe, MD; University Hopsital Tübingen
• Study Chair: Rudolf Stadler, MD; Johannes Wesling Klinikum Minden

• PRS Account: University Hospital Tuebingen
• Verification Date: May 2017