BMJ Open (Oct 2024)

Optimised treatment of patients with enlarged lateral lymph nodes in rectal cancer: protocol of an international, multicentre, prospective registration study after extensive multidisciplinary training (LaNoReC)

  • ,
  • Susan Van Dieren,
  • Joost Nederend,
  • Pieter J Tanis,
  • Roel Hompes,
  • Klaas Havenga,
  • Melissa W Taggart,
  • Robert Riedl,
  • Michail Doukas,
  • Evert-Jan G. Boerma,
  • Marinke Westerterp,
  • Corrie A M Marijnen,
  • Jaap Stoker,
  • Andrew Ruszkiewicz,
  • Tsuyoshi Konishi,
  • Jarno Melenhorst,
  • Karin Muller,
  • Krista Gerbrands,
  • Michael Croft,
  • Michael Wilks,
  • Johanne G. Bloemen,
  • Peter A. Neijenhuis,
  • Koen C.M.J. Peeters,
  • Miranda Kusters,
  • Martijn Intven,
  • Jan Peringa,
  • Maria Verseveld,
  • Eline G M van Geffen,
  • Tania C Sluckin,
  • Sanne-Marije J A Hazen,
  • Karin Horsthuis,
  • Geerard Beets,
  • Marilyne M Lange,
  • Regina G H Beets-Tan,
  • Marc R. W. Engelbrecht,
  • Elisabeth D. Geijsen,
  • Philip Meijnen,
  • Jurriaan B. Tuynman,
  • Ingrid M. Bruijnzeel,
  • Bas Lamme,
  • Femke M. Alberts,
  • Rogier M. P. H. Crolla,
  • Joanne Verdult,
  • Johan H. Wijsman,
  • Charlotte S. van Kessel,
  • Erik Jan Mulder,
  • Jan Binne Hulshoff,
  • Ivan M. Cherepanin,
  • Hans F. J. Fabry,
  • G. Y. Mireille,
  • Frank J. M. Kemper,
  • Fatih Polat,
  • Jacobus W. A. Burger,
  • Jeltsje S. Cnossen,
  • Shira H. de Bie,
  • Robbert J. I. Bosker,
  • Aaldert K. Talsma,
  • Leonora S. F. Boogerd,
  • Marc J. P. M. Govaert,
  • Merel M. Scheurkogel,
  • Imogeen E. Antonisse,
  • Joost Rothbarth,
  • Marianne de Vries,
  • Marcel A. H. Ribbert,
  • Anthony W. H. van de Ven,
  • Susan ter Borg,
  • Jennifer W. Bradshaw,
  • Heleen M. Ceha,
  • Fleur I. de Korte,
  • Andreas W. K. S. Marinelli,
  • Tjeerd S. Aukema,
  • Liselotte W. van Bockel,
  • Aukje A. J. M. van Tilborg,
  • Tom Rozema,
  • Amarins Brandsma,
  • Stefan Hoogendoorn,
  • Saskia R. Offerman,
  • Hanneke Vos,
  • Henderik L. van Westreenen,
  • Jeroen W. A. Leijtens,
  • Fabian A. Holman,
  • Laura A. Velema,
  • L Els,
  • van Persijn van Meerten,
  • Frans C. H. Bakers,
  • Iryna Samarska,
  • Nina Šefčovičová,
  • Maaike Berbée,
  • Bastiaan B. Pultrum,
  • Dennis B. Rouw,
  • Matthew Albert,
  • L. René Arensman,
  • Hanneke Basart,
  • Esther C. J. Consten,
  • Bart C.T. van de Laar,
  • Inne Somers,
  • Paul M. Verheijen,
  • Thomas A. Fassaert,
  • Christiaan Hoff,
  • Eino B. van Duyn,
  • Ellen M. Hendriksen,
  • Hugo A.J. Gielkens,
  • Arend G. J. Aalbers,
  • Brechtje A. Grotenhuis,
  • Michalda S. Dunker,
  • Anne M. van Geel,
  • Christof Meischl,
  • W. Hermien Schreurs,
  • Patty H. Spruit,
  • Michael F. Gerhards,
  • Thomas M. Karsten,
  • Eveline J.T. Krul,
  • Sebastiaan van Koeverden,
  • Andre J. A. Bremers,
  • Heidi Rütten,
  • Johannes H. W. de Wilt,
  • Mariska den Hartogh,
  • Vera Oppedijk,
  • Jan Willem T. Dekker,
  • Debora Eschbach-Zandbergen,
  • Daphne Roos,
  • Arjan van Tilburg,
  • Ernst Jan,
  • Spillenaar Bilgen,
  • Nikki Knijn,
  • Marnix A. J. de Roos,
  • Ilse van Dop,
  • Tracy Fitzsimmons,
  • Hidde M. Kroon,
  • Michael Penniment,
  • Mitchell Raeside,
  • Tarik Sammour,
  • Steven J. Oosterling,
  • Jeroen A. W. Tielbeek,
  • Ronald J. C. L. M. Vuylsteke,
  • Erik J. R. J. van der Hoeven,
  • Anke B. Smits,
  • Anniek H. Boer,
  • Edgar J. B. Furnée,
  • Robbert J. de Haas,
  • Manon N. G. J. A. Braat,
  • Wilhelmina M. U. van Grevenstein,
  • Milan C. Richir,
  • Patricia J. A. M. Brouwers,
  • Tilly Leseman,
  • Eric H. J. Belgers,
  • Jasenko Krdzalic,
  • Roy F. A. Vliegen

DOI
https://doi.org/10.1136/bmjopen-2023-083225
Journal volume & issue
Vol. 14, no. 10

Abstract

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Introduction Inadequate treatment of enlarged lateral lymph nodes (LLNs) in rectal cancer patients is associated with an increased lateral local recurrence (LLR) risk, despite neoadjuvant treatment and total mesorectal excision (TME) surgery. There is a promising role for LLN dissection (LLND) to lower this risk, but this challenging procedure requires appropriate training. This study protocol describes a prospective evaluation of oncological outcomes after standardised treatment based on multidisciplinary training, thereby aiming for a 50% reduction in LLR rate.Methods and analysis A prospective registration study will be opened in hospitals in which the involved multidisciplinary team members (radiologists, radiation oncologists, surgeons and pathologists) have received dedicated training to enhance knowledge and awareness of LLNs and in which standardised treatment including LLND has been implemented. Patients with rectal cancer and at least one enlarged LLN (short-axis ≥7.0 mm), or intermediate LLN (short-axis 5.0–6.9 mm) with at least one malignant feature on primary MRI, evaluated by a trained radiologist, are eligible. Patients will undergo neoadjuvant treatment by trained radiation oncologists, followed by TME surgery in combination with a minimally invasive, nerve-sparing LLND performed by trained surgeons. LLND specimens are evaluated by trained pathologists or grossing assistants. The primary outcome is LLR rate 3 years postoperatively. Secondary outcomes are morbidity, disease-free survival, overall survival and quality of life. To demonstrate a significant reduction in LLR rate from 13% (based on historical control data) to 6% after optimised treatment, 200 patients with enlarged LLNs are required.Ethics and dissemination The medical ethics board of the Vrije Universiteit Medical Centre (VUMC), the Netherlands, approved the study on 23 November 2022 (reference: 2021.0524). Participating centres must obtain local approval and participants are required to provide written informed consent. Results obtained from this study will be communicated via peer-reviewed medical journals and presentations at conferences.Trail registration number NCT04486131, 24 July 2020, https://clinicaltrials.gov/ct2/show/NCT04486131.