Evidence map›Paper›PMID 34432481›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2021

Radiotherapy Versus Inguinofemoral Lymphadenectomy as Treatment for Vulvar Cancer Patients With Micrometastases in the Sentinel Node: Results of GROINSS-V II.

Maaike H M Oonk, Brian Slomovitz, Peter J W Baldwin, Helena C van Doorn, Jacobus van der Velden, Joanne A de Hullu, Katja N Gaarenstroom, Brigitte F M Slangen, Ignace Vergote, Mats Brännström and 49 more

Open access · hybridAbstract readClinical Trial, Phase IIComparative StudyMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed, 3 pooled it
14.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

46 citing papers in PubMed, 3 syntheses or guidelines pooled it, 116 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. European Society of Gynaecological Oncology Guidelines for the Management of Patients with Vulvar Cancer - Update 2023.International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2023
    Guideline
  4. Trial
  5. Article
  6. Review
  7. Article
  8. Review
  9. Review
  10. Article
  11. Review
  12. Review
  13. Article
  14. Cancer of the vulva: 2025 update: FIGO Cancer Report 2025.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2025
    Article
  15. Review
  16. Review
  17. Review
  18. Review
  19. Sentinel lymph node biopsy for early stage vulvar squamous cell carcinoma.Proceedings (Baylor University. Medical Center) · 2025
    Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

59 authors at 20 institutions in 10 countries.

Maaike H M OonkUniversity Medical Center Groningen, University of Groningen, Groningen, the Netherlands.ORCID 0000-0002-3261-3632
Brian SlomovitzMount Sinai Medical Center, Miami Beach, FL.ORCID 0000-0002-7241-3096
Peter J W BaldwinCambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom.
Helena C van DoornErasmus MC Cancer Institute, University Medical Center Rotterdam, Rotterdam, the Netherlands.
Jacobus van der VeldenAmsterdam University Medical Center, Amsterdam, the Netherlands.ORCID 0000-0002-5985-1163
Joanne A de HulluRadboud University Medical Center, Nijmegen, the Netherlands.
Katja N GaarenstroomLeiden University Medical Center, Leiden, the Netherlands.
Brigitte F M SlangenMaastricht University Medical Center+, Maastricht, the Netherlands.ORCID 0000-0003-2811-3851
Ignace VergoteLeuven Cancer Institute, Leuven, Belgium.ORCID 0000-0002-7589-8981
Mats BrännströmSahlgrenska Academy, University of Gothenburg, Göteborg, Sweden.ORCID 0000-0002-6081-9101
Eleonora B L van DorstUniversity Medical Center Utrecht, Utrecht, the Netherlands.
Willemien J van DrielCenter of Gynecological Oncology Amsterdam, The Netherlands Cancer Institute, Amsterdam, the Netherlands.ORCID 0000-0003-2246-1994
Ralph H HermansCatharina Ziekenhuis Eindhoven, the Netherlands.
David NunnsNottingham University Hospitals NHS Trust, Nottingham, United Kingdom.
Martin WidschwendterUCL EGA Institute for Women's Health, University College London, London, United Kingdom.
David NugentLeeds Teaching Hospitals NHS Trust, St James' University Hospital, Leeds, United Kingdom.
Cathrine M HollandManchester University NHS Foundation Trust-St Marys Hospital, Manchester, United Kingdom.
Aarti SharmaUniversity Hospital of Wales, Cardiff, United Kingdom.
Paul A DiSilvestroWomen and Infants Hospital of Rhode Island, Providence, RI.ORCID 0000-0003-2711-6663
Robert MannelStephenson Cancer Center, University of Oklahoma, Oklahoma City, OK.
Dorry BollCatharina Ziekenhuis Eindhoven, the Netherlands.
David CibulaFirst Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic.ORCID 0000-0001-6387-9356
Al CovensUniversity of Toronto, Toronto, Ontario, Canada.
Diane ProvencherCHUM, Université de Montréal, Montréal, Quebec, Canada.
Ingo B RunnebaumJena University Hospital, Friedrich Schiller University, Jena, Germany.
David LuesleyUniversity of Birmingham, Birmingham, United Kingdom.ORCID 0000-0003-3706-0245
Patricia EllisRoyal Surrey NHS Foundation Trust, Guildford, United Kingdom.
Timothy J DuncanNorfolk and Norwich University Hospital NHS Trust, Norwich, United Kingdom.
Ming Y TjiongAmsterdam University Medical Center, Amsterdam, the Netherlands.
Derek J CruickshankJames Cook University Hospital, South Tees NHS Foundation Trust, Middlesbrough, United Kingdom.
Preben KjølhedeLinköping University, Linköping, Sweden.ORCID 0000-0001-5702-4116
Charles F LevenbackMD Anderson Cancer Center, Houston, TX.
Jiri BoudaUniversity Hospital Pilsen, Charles University, Faculty of Medicine, Pilsen, Czech Republic.ORCID 0000-0003-2954-9817
Katharina E KieserDalhousie University, Halifax, Nova Scotia, Canada.
Connie PalleCapio, Part of Ramsey Santé, Hellerup, Denmark.ORCID 0000-0003-2299-1143
Nicola M SpirtosWomen's Cancer Center of Nevada, Las Vegas, NV.
David M O'MalleyOhio State University Comprehensive Cancer Center-James Cancer Hospital, Columbus, OH.ORCID 0000-0002-2828-0177
Mario M LeitaoMemorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0003-0818-3836
Melissa A GellerUniversity of Minnesota, Minneapolis, MN.
Kalyan DharSingleton Hospital, Swansea, United Kingdom.ORCID 0000-0001-6907-6191
Viren AsherUniversity Hospitals of Derby and Burton, Derby, United Kingdom.
Karl TamussinoMedical University Graz, Graz, Austria.ORCID 0000-0001-5016-4669
Daniel H TobiasMorristown Medical Center, Morristown, NJ.
Christer BorgfeldtSkåne University Hospital, Lund University, Lund, Sweden.
Jayanthi S LeaUT Southwestern Medical Center, Dallas, TX.
Jo BaileySt Michaels Hospital, Bristol, United Kingdom.
Margareta LoodCentral Hospital Karlstad, Karlstad, Sweden.
Brynhildur EyjolfsdottirOslo University Hospital, Radiumhospitalet, Oslo, Norway.
Stephen Attard-MontaltoWest Kent Cancer Centre, Maidstone Hospital, Maidstone, United Kingdom.
Krishnansu S TewariUC Irvine Health Medical Center, Orange, CA.ORCID 0000-0002-8417-7000
Ranjit ManchandaWolfson Institute of Population Health, Queen Mary University of London, London, United Kingdom.ORCID 0000-0003-3381-5057
Pernille T JensenAarhus University Hospital, Aarhus, Denmark.ORCID 0000-0002-1637-6040
Par PerssonUppsala University, Uppsala, Sweden.
Linda Van LeUniversity of North Carolina, Chapel Hill, NC.ORCID 0000-0002-0473-7371
Hein PutterLeiden University Medical Center, Leiden, the Netherlands.ORCID 0000-0001-5395-1422
Geertruida H de BockUniversity Medical Center Groningen, University of Groningen, Groningen, the Netherlands.ORCID 0000-0003-3104-4471
Bradley J MonkSt Josephs Hospital and Medical Center, Phoenix, AZ.ORCID 0000-0001-6985-0159
Carien L CreutzbergLeiden University Medical Center, Leiden, the Netherlands.ORCID 0000-0002-7008-4321
Ate G J van der ZeeUniversity Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
Leiden University Medical Center · NLRadboud University Nijmegen · NLUniversity Medical Center Groningen · NLAmsterdam University Medical Centers · NLCharles University · CZAarhus University Hospital · DKCambridge University Hospitals NHS Foundation Trust · GBDalhousie University · CAErasmus MC Cancer Institute · NLJames Cook University Hospital · GBJena University Hospital · DEKarlstad Central Hospital · SELeeds Teaching Hospitals NHS Trust · GBLinköping University · SELund University · SEMaastricht University · NLMaidstone Hospital · GBMedical University of Graz · ATMemorial Sloan Kettering Cancer Center · USMorristown Medical Center · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
NRG Oncology NCORP Research Base-BIQSFPUG1CA189867 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Deborah Watkins Bruner, Lisa A. Kachnic · 2014 to 2026
$140.5M
Translational Therapeutics Research Program (TT)P30CA016058 · NCI · OHIO STATE UNIVERSITY · PI Tasleem J Padamsee · 1985 to 2026
$132.3M
A Lead Academic Participating Site in Oklahoma for the Design and Conduct of NCTN Clinical TrialsUG1CA233193 · NCI · UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR · PI Muhammad Furqan · 2019 to 2026
$13.7M
OSU as a Network Lead Academic Participating Site for the NCI NCTNUG1CA233331 · NCI · OHIO STATE UNIVERSITY · PI John L. Hays, Dwight H. Owen · 2019 to 2026
$8.9M
NCI NIH HHS P30 CA008748NCI NIH HHS P30 CA016058NCI NIH HHS UG1 CA189867NCI NIH HHS UG1 CA233193NCI NIH HHS UG1 CA233331
6 · The paper itself

Abstract

purposeThe Groningen International Study on Sentinel nodes in Vulvar cancer (GROINSS-V)-II investigated whether inguinofemoral radiotherapy is a safe alternative to inguinofemoral lymphadenectomy (IFL) in vulvar cancer patients with a metastatic sentinel node (SN).

methodsGROINSS-V-II was a prospective multicenter phase-II single-arm treatment trial, including patients with early-stage vulvar cancer (diameter < 4 cm) without signs of lymph node involvement at imaging, who had primary surgical treatment (local excision with SN biopsy). Where the SN was involved (metastasis of any size), inguinofemoral radiotherapy was given (50 Gy). The primary end point was isolated groin recurrence rate at 24 months. Stopping rules were defined for the occurrence of groin recurrences.

resultsFrom December 2005 until October 2016, 1,535 eligible patients were registered. The SN showed metastasis in 322 (21.0%) patients. In June 2010, with 91 SN-positive patients included, the stopping rule was activated because the isolated groin recurrence rate in this group went above our predefined threshold. Among 10 patients with an isolated groin recurrence, nine had SN metastases > 2 mm and/or extracapsular spread. The protocol was amended so that those with SN macrometastases (> 2 mm) underwent standard of care (IFL), whereas patients with SN micrometastases (≤ 2 mm) continued to receive inguinofemoral radiotherapy. Among 160 patients with SN micrometastases, 126 received inguinofemoral radiotherapy, with an ipsilateral isolated groin recurrence rate at 2 years of 1.6%. Among 162 patients with SN macrometastases, the isolated groin recurrence rate at 2 years was 22% in those who underwent radiotherapy, and 6.9% in those who underwent IFL (

conclusionInguinofemoral radiotherapy is a safe alternative for IFL in patients with SN micrometastases, with minimal morbidity. For patients with SN macrometastasis, radiotherapy with a total dose of 50 Gy resulted in more isolated groin recurrences compared with IFL.

Indexed as

Lymph Node ExcisionRadiation DosageSentinel Lymph NodeVulvar NeoplasmsAgedFemaleHumansLymphatic MetastasisMiddle AgedNeoplasm MicrometastasisNeoplasm StagingProspective StudiesTime FactorsTreatment Outcome

Identifiers

PMID34432481
PMCPMC8577685
OpenAlexW3195589874

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.