A national, multicentre, randomised, controlled, parallel-arms, phase III clinical trial of neoadjuvant FOLFOXIRI and chemoradiotherapy versus neoadjuvant CAPOX/FOLFOX and chemoradiotherapy in patients with high-risk locally advanced rectal cancer: study protocol of the MEND-IT II trial.

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Title: A national, multicentre, randomised, controlled, parallel-arms, phase III clinical trial of neoadjuvant FOLFOXIRI and chemoradiotherapy versus neoadjuvant CAPOX/FOLFOX and chemoradiotherapy in patients with high-risk locally advanced rectal cancer: study protocol of the MEND-IT II trial.
Authors: Banken E; Department of Medical Oncology, Catharina Hospital Eindhoven, Michelangelolaan 2, Eindhoven, 5623 EJ, The Netherlands. evi.banken@catharinaziekenhuis.nl.; Department of Surgery, Catharina Hospital Eindhoven, Michelangelolaan 2, Eindhoven, 5623EJ, the Netherlands. evi.banken@catharinaziekenhuis.nl.; GROW Research Institute for Oncology and Reproduction, Maastricht University, Maastricht, the Netherlands. evi.banken@catharinaziekenhuis.nl., Borg M; Department of Medical Oncology, Catharina Hospital Eindhoven, Michelangelolaan 2, Eindhoven, 5623 EJ, The Netherlands.; Department of Surgery, Catharina Hospital Eindhoven, Michelangelolaan 2, Eindhoven, 5623EJ, the Netherlands.; GROW Research Institute for Oncology and Reproduction, Maastricht University, Maastricht, the Netherlands., van Hellemond IEG; Department of Medical Oncology, Catharina Hospital Eindhoven, Michelangelolaan 2, Eindhoven, 5623 EJ, The Netherlands., van Ravensteijn SG; Department of Medical Oncology, Catharina Hospital Eindhoven, Michelangelolaan 2, Eindhoven, 5623 EJ, The Netherlands., Peulen HMU; Department of Radiotherapy, Catharina Hospital, Eindhoven, the Netherlands., Verrijssen AE; Department of Radiotherapy, Catharina Hospital, Eindhoven, the Netherlands., Nederend J; Department of Radiology, Catharina Hospital, Eindhoven, the Netherlands., Daniels-Gooszen AW; Department of Radiology, Catharina Hospital, Eindhoven, the Netherlands., van Oudheusden TR; Department of Radiology, Catharina Hospital, Eindhoven, the Netherlands., van Lijnschoten G; Department of Pathology, PAMM Laboratory for Pathology and Medical Microbiology, Eindhoven, the Netherlands., Bloemen JG; Department of Surgery, Catharina Hospital Eindhoven, Michelangelolaan 2, Eindhoven, 5623EJ, the Netherlands., Rutten HJT; Department of Surgery, Catharina Hospital Eindhoven, Michelangelolaan 2, Eindhoven, 5623EJ, the Netherlands.; GROW Research Institute for Oncology and Reproduction, Maastricht University, Maastricht, the Netherlands., van Westreenen HL; Department of Surgery, Isala, Zwolle, the Netherlands., de Groot JWB; Department of Medical Oncology, Isala, Zwolle, the Netherlands., Verhoef C; Department of Surgery, Erasmus Medical Center, Rotterdam, the Netherlands., Tanis PJ; Department of Surgery, Erasmus Medical Center, Rotterdam, the Netherlands., Grotenhuis BA; Department of Surgery, Antoni Van Leeuwenhoek, Amsterdam, the Netherlands., Aalbers AGJ; Department of Surgery, Antoni Van Leeuwenhoek, Amsterdam, the Netherlands., Werter IM; Department of Medical Oncology, Rijnstate, Arnhem, the Netherlands., Hartogh MDD; Department of Radiotherapy, Radiotherapiegroep, Arnhem, the Netherlands., Douma JAJ; Department of Medical Oncology, Frisius Medical Center, Location Leeuwarden, Leeuwarden, the Netherlands., Calon TGA; Department of Internal Medicine, Division of Medical Oncology, Maastricht University Medical Center, Maastricht, the Netherlands., Iersel LBJV; GROW Research Institute for Oncology and Reproduction, Maastricht University, Maastricht, the Netherlands.; Department of Internal Medicine, Division of Medical Oncology, Maastricht University Medical Center, Maastricht, the Netherlands., Beets GL; Department of Surgery, Maastricht University Medical Center, Maastricht, the Netherlands., Tuynman JB; Department of Surgery, Amsterdam University Medical Center, Amsterdam, the Netherlands., Intven MPW; Department of Radiotherapy, Utrecht University Medical Center, Utrecht, the Netherlands., van Kuijk SMJ; Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht, the Netherlands., Berbée M; Department of Radiation Oncology (Maastro), GROW School for Oncology and Reproduction, Maastricht University Medical Centre, Maastricht, the Netherlands., Buffart TE; Department of Medical Oncology, Amsterdam University Medical Center, Cancer Center Amsterdam, Amsterdam, the Netherlands., Roodhart JML; Department of Medical Oncology, Utrecht University Medical Center, Utrecht University, Utrecht, the Netherlands., Burger JWA; Department of Surgery, Catharina Hospital Eindhoven, Michelangelolaan 2, Eindhoven, 5623EJ, the Netherlands.; GROW Research Institute for Oncology and Reproduction, Maastricht University, Maastricht, the Netherlands.
Corporate Authors: Dutch Colorectal Cancer Group
Source: BMC cancer [BMC Cancer] 2026 May 18; Vol. 26 (1). Date of Electronic Publication: 2026 May 18.
Publication Type: Journal Article; Clinical Trial Protocol
Journal Info: Publisher: BioMed Central Country of Publication: England NLM ID: 100967800 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2407 (Electronic) Linking ISSN: 14712407 NLM ISO Abbreviation: BMC Cancer Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: A national, multicentre, randomised, controlled, parallel-arms, phase III clinical trial of neoadjuvant FOLFOXIRI and chemoradiotherapy versus neoadjuvant CAPOX/FOLFOX and chemoradiotherapy in patients with high-risk locally advanced rectal cancer: study protocol of the MEND-IT II trial.
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  Data: <searchLink fieldCode="AU" term="%22Banken+E%22">Banken E</searchLink>; Department of Medical Oncology, Catharina Hospital Eindhoven, Michelangelolaan 2, Eindhoven, 5623 EJ, The Netherlands. evi.banken@catharinaziekenhuis.nl.; Department of Surgery, Catharina Hospital Eindhoven, Michelangelolaan 2, Eindhoven, 5623EJ, the Netherlands. evi.banken@catharinaziekenhuis.nl.; GROW Research Institute for Oncology and Reproduction, Maastricht University, Maastricht, the Netherlands. evi.banken@catharinaziekenhuis.nl.<br /><searchLink fieldCode="AU" term="%22Borg+M%22">Borg M</searchLink>; Department of Medical Oncology, Catharina Hospital Eindhoven, Michelangelolaan 2, Eindhoven, 5623 EJ, The Netherlands.; Department of Surgery, Catharina Hospital Eindhoven, Michelangelolaan 2, Eindhoven, 5623EJ, the Netherlands.; GROW Research Institute for Oncology and Reproduction, Maastricht University, Maastricht, the Netherlands.<br /><searchLink fieldCode="AU" term="%22van+Hellemond+IEG%22">van Hellemond IEG</searchLink>; Department of Medical Oncology, Catharina Hospital Eindhoven, Michelangelolaan 2, Eindhoven, 5623 EJ, The Netherlands.<br /><searchLink fieldCode="AU" term="%22van+Ravensteijn+SG%22">van Ravensteijn SG</searchLink>; Department of Medical Oncology, Catharina Hospital Eindhoven, Michelangelolaan 2, Eindhoven, 5623 EJ, The Netherlands.<br /><searchLink fieldCode="AU" term="%22Peulen+HMU%22">Peulen HMU</searchLink>; Department of Radiotherapy, Catharina Hospital, Eindhoven, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Verrijssen+AE%22">Verrijssen AE</searchLink>; Department of Radiotherapy, Catharina Hospital, Eindhoven, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Nederend+J%22">Nederend J</searchLink>; Department of Radiology, Catharina Hospital, Eindhoven, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Daniels-Gooszen+AW%22">Daniels-Gooszen AW</searchLink>; Department of Radiology, Catharina Hospital, Eindhoven, the Netherlands.<br /><searchLink fieldCode="AU" term="%22van+Oudheusden+TR%22">van Oudheusden TR</searchLink>; Department of Radiology, Catharina Hospital, Eindhoven, the Netherlands.<br /><searchLink fieldCode="AU" term="%22van+Lijnschoten+G%22">van Lijnschoten G</searchLink>; Department of Pathology, PAMM Laboratory for Pathology and Medical Microbiology, Eindhoven, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Bloemen+JG%22">Bloemen JG</searchLink>; Department of Surgery, Catharina Hospital Eindhoven, Michelangelolaan 2, Eindhoven, 5623EJ, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Rutten+HJT%22">Rutten HJT</searchLink>; Department of Surgery, Catharina Hospital Eindhoven, Michelangelolaan 2, Eindhoven, 5623EJ, the Netherlands.; GROW Research Institute for Oncology and Reproduction, Maastricht University, Maastricht, the Netherlands.<br /><searchLink fieldCode="AU" term="%22van+Westreenen+HL%22">van Westreenen HL</searchLink>; Department of Surgery, Isala, Zwolle, the Netherlands.<br /><searchLink fieldCode="AU" term="%22de+Groot+JWB%22">de Groot JWB</searchLink>; Department of Medical Oncology, Isala, Zwolle, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Verhoef+C%22">Verhoef C</searchLink>; Department of Surgery, Erasmus Medical Center, Rotterdam, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Tanis+PJ%22">Tanis PJ</searchLink>; Department of Surgery, Erasmus Medical Center, Rotterdam, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Grotenhuis+BA%22">Grotenhuis BA</searchLink>; Department of Surgery, Antoni Van Leeuwenhoek, Amsterdam, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Aalbers+AGJ%22">Aalbers AGJ</searchLink>; Department of Surgery, Antoni Van Leeuwenhoek, Amsterdam, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Werter+IM%22">Werter IM</searchLink>; Department of Medical Oncology, Rijnstate, Arnhem, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Hartogh+MDD%22">Hartogh MDD</searchLink>; Department of Radiotherapy, Radiotherapiegroep, Arnhem, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Douma+JAJ%22">Douma JAJ</searchLink>; Department of Medical Oncology, Frisius Medical Center, Location Leeuwarden, Leeuwarden, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Calon+TGA%22">Calon TGA</searchLink>; Department of Internal Medicine, Division of Medical Oncology, Maastricht University Medical Center, Maastricht, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Iersel+LBJV%22">Iersel LBJV</searchLink>; GROW Research Institute for Oncology and Reproduction, Maastricht University, Maastricht, the Netherlands.; Department of Internal Medicine, Division of Medical Oncology, Maastricht University Medical Center, Maastricht, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Beets+GL%22">Beets GL</searchLink>; Department of Surgery, Maastricht University Medical Center, Maastricht, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Tuynman+JB%22">Tuynman JB</searchLink>; Department of Surgery, Amsterdam University Medical Center, Amsterdam, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Intven+MPW%22">Intven MPW</searchLink>; Department of Radiotherapy, Utrecht University Medical Center, Utrecht, the Netherlands.<br /><searchLink fieldCode="AU" term="%22van+Kuijk+SMJ%22">van Kuijk SMJ</searchLink>; Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Berbée+M%22">Berbée M</searchLink>; Department of Radiation Oncology (Maastro), GROW School for Oncology and Reproduction, Maastricht University Medical Centre, Maastricht, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Buffart+TE%22">Buffart TE</searchLink>; Department of Medical Oncology, Amsterdam University Medical Center, Cancer Center Amsterdam, Amsterdam, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Roodhart+JML%22">Roodhart JML</searchLink>; Department of Medical Oncology, Utrecht University Medical Center, Utrecht University, Utrecht, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Burger+JWA%22">Burger JWA</searchLink>; Department of Surgery, Catharina Hospital Eindhoven, Michelangelolaan 2, Eindhoven, 5623EJ, the Netherlands.; GROW Research Institute for Oncology and Reproduction, Maastricht University, Maastricht, the Netherlands.
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