MelanomaDeCOG-SLTNCT02434107
Complete Lymph Node Dissection vs Watchful Waiting in Patients With Malignant Melanoma (Thickness of 1,0mm+ and Evidence of Metastases in the Sentinel Node)
A study testing Completion Lymphadenectomy and Clinical Monitoring (Palpation and node ultrasound) in people with Melanoma, run by University Hospital Tuebingen at 41 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Melanoma
- What is being tested?
- Completion Lymphadenectomy and Clinical Monitoring (Palpation and node ultrasound)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 483 participants
- Where
- 41 sitesGermany
- Study dates
- Dec 2005to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cutaneous melanoma with a tumour thickness of at least 1,00mm
- Positive sentinel node with micro metastases of max. 2mm in diameter
Who cannot join
- 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
Trial locations and contacts
41 sites in 1 country.
41 sites in 1 country
Germany41 sites
Humboldt-Universität Berlin Charité
Berlin, 10117
Krankenhaus Neukölln
Berlin, 12351
Universtitäts-Hautklinik Bochum
Bochum, 44791
Zentralkrankenhaus
Bremen, 28205
Universität Köln
Cologne, 50924
Carl-Thiem Klinikum
Cottbus, 03048
Städtische Kliniken Darmstadt
Darmstadt, 64297
Städtische Kliniken Dessau
Dessau, 06847
Städtisches Klinikum Friedrichsstadt
Dresden, 01067
Universitätsklinikum Carl Gustav Carus
Dresden, 01307
Heinrich Heine Universität
Düsseldorf, 40225
Klinikum Erfurt GmbH
Erfurt, 99089
Universitätsklinikum Erlangen
Erlangen, 91052
Universitätsklinikum Essen
Essen, 45122
Klinkum der J. W. Goethe Universität
Frankfurt am Main, 60590
Klinikum der Albert-Ludwigs-Universität
Freiburg im Breisgau, 79104
Justus-Liebig-Universität
Giessen, 35385
Georg-August Universität
Göttingen, 37075
Allgemeines Krankenhaus St. Georg
Hamburg, 20099
Klinikum de Ruprecht-Karls-Universität
Heidelberg, 69115
Universitätsklinikum des Saarlandes
Homburg/Saar, 66421
Klinikum der Friedrich Schiller Universität
Jena, 07740
Städtische Hautklinik Karlsruhe
Karlsruhe, 76133
Städtische Kliniken Kassel
Kassel, 34125
Universität Leipzig
Leipzig, 04103
Klinkum Lippe-Lemgo GmbH
Lemgo, 32657
Universitätsklinikum Lübeck
Lübeck, 23538
Otto-von-Guericke-Universität
Magdeburg, 39120
Klinik der Philipps-Universität
Marburg, 35033
Johannes Wesling Klinikum Minden
Minden, 32429
Ludwig-Maximilians-Universität
Munich, 80337
Technische Universität
Munich, 80802
Städt. Krankenhaus München-Schwabing
Munich, 80804
Universitätsklinkum Münster
Münster, 48149
Städtische Kliniken Oldenburg
Oldenburg, 26133
Klinkum der Universität
Regensburg, 93053
Eberhard-Karls Universität
Tübingen, 72076
Universitätsklinikum Ulm
Ulm, 89081
Katholisches Krankenhaus
Unna, 59423
Klinkum Wuppertal GmbH
Wuppertal, 42117
Universitätsklinik und Poliklinik
Würzburg, 97080
About this study
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
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.
- Conditions
- Melanoma
- Being tested
- Completion Lymphadenectomy, Clinical Monitoring (Palpation and node ultrasound)
- Keywords
- Sentinel Lymph Node Biopsy, Lymph Node Excision
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Completion LymphadenectomyProcedure or surgery
Clinical Monitoring (Palpation and node ultrasound)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Completion Lymphadenectomy | Experimental | Completion Lymphadenectomy and monitoring afterwards Receives: Procedure: Completion Lymphadenectomy |
| Clinical Monitoring (Palpation and node ultrasound) | Experimental | Monitoring only Receives: Procedure: Clinical Monitoring (Palpation and node ultrasound) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distant metastases free survival
Measured: 3 Years
Secondary outcomes (1)
Distant metastases free survival
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startDec 2005
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 483 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claus Garbe, MD, Study director, University Hopsital TübingenRudolf Stadler, MD, Study chair, Johannes Wesling Klinikum Minden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434107
- Sponsor's protocol ID
- V1410112004
- Acronym
- DeCOG-SLT
- Status last verified
- May 2017
- First submitted
- 2 Apr 2015
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 31557067Leiter 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.
PubMed 27161539
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02434107
- Acronym / sponsor ID
- DeCOG-SLT / V1410112004
- Conditions
- Melanoma
- Keywords
- Sentinel Lymph Node Biopsy, Lymph Node Excision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 483 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Dec 2005 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 5 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Completion Lymphadenectomy | Experimental | Procedure: Completion LymphadenectomyCompletion Lymphadenectomy and monitoring afterwards |
| Clinical Monitoring (Palpation and node ultrasound) | Experimental | Procedure: Clinical Monitoring (Palpation and node ultrasound)Monitoring only |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cutaneous melanoma with a tumour thickness of at least 1,00mm
- Positive sentinel node with micro metastases of max. 2mm in diameter
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Completion Lymphadenectomy | Procedure or surgery | Completion Lymphadenectomy |
| Clinical Monitoring (Palpation and node ultrasound) | Procedure or surgery | Clinical Monitoring (Palpation and node ultrasound) |
Primary outcome
Distant metastases free survival
Time frame: 3 Years
1 secondary outcome
Distant metastases free survival
Time frame: 5 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Derived from this study: PubMed 31557067Leiter 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.
- Derived from this study: PubMed 27161539Leiter 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claus Garbe, MD study director
University Hopsital Tübingen
Rudolf Stadler, MD study chair
Johannes Wesling Klinikum Minden
41 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Completion Lymphadenectomy and Clinical Monitoring (Palpation and node ultrasound) in people with Melanoma, run by University Hospital Tuebingen at 41 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distant metastases free survival (time frame: 3 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02434107, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.