Induction chemotherapy followed by chemoradiotherapy versus chemoradiotherapy alone as neoadjuvant treatment for locally recurrent rectal cancer: study protocol of a multicentre, open-label, parallel-arms, randomized controlled study (PelvEx II)

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dc.contributor.authorVoogt, E.L.K.
dc.contributor.authorNordkamp, S.
dc.contributor.authorAalbers, A.G.J.
dc.contributor.authorBuffart, T.
dc.contributor.authorCreemers, G.J.
dc.contributor.authorMarijnen, C.A.M.
dc.contributor.authorVerhoef, C.
dc.contributor.authorHavenga, K.
dc.contributor.authorHolman, F.A.
dc.contributor.authorKusters, M.
dc.contributor.authorMarinelli, A.W.K.S.
dc.contributor.authorMelenhorst, J.
dc.contributor.authorAbdul Aziz, N.
dc.contributor.authorAbecasis, N.
dc.contributor.authorAbraham-Nordling, M.
dc.contributor.authorAkiyoshi, T.
dc.contributor.authorAlberda, W.
dc.contributor.authorAlbert, M.
dc.contributor.authorAndric, M.
dc.contributor.authorAngenete, E.
dc.contributor.authoret al.
dc.date.issued2021
dc.description.abstractBackground: A resection with clear margins (R0 resection) is the most important prognostic factor in patients with locally recurrent rectal cancer (LRRC). However, this is achieved in only 60 per cent of patients. The aim of this study is to investigate whether the addition of induction chemotherapy to neoadjuvant chemo(re)irradiation improves the R0 resection rate in LRRC. Methods: This multicentre, international, open-label, phase III, parallel-arms study will enrol 364 patients with resectable LRRC after previous partial or total mesorectal resection without synchronous distant metastases or recent chemo- and/or radiotherapy treatment. Patients will be randomized to receive either induction chemotherapy (three 3-week cycles of CAPOX (capecitabine, oxaliplatin), four 2-week cycles of FOLFOX (5-fluorouracil, leucovorin, oxaliplatin) or FOLFORI (5-fluorouracil, leucovorin, irinotecan)) followed by neoadjuvant chemoradiotherapy and surgery (experimental arm) or neoadjuvant chemoradiotherapy and surgery alone (control arm). Tumours will be restaged using MRI and, in the experimental arm, a further cycle of CAPOX or two cycles of FOLFOX/FOLFIRI will be administered before chemoradiotherapy in case of stable or responsive disease. The radiotherapy dose will be 25 × 2.0 Gy or 28 × 1.8 Gy in radiotherapy-naive patients, and 15 × 2.0 Gy in previously irradiated patients. The concomitant chemotherapy agent will be capecitabine administered twice daily at a dose of 825 mg/m2 on radiotherapy days. The primary endpoint of the study is the R0 resection rate. Secondary endpoints are long-term oncological outcomes, radiological and pathological response, toxicity, postoperative complications, costs, and quality of life. Discussion: This trial protocol describes the PelvEx II study. PelvEx II, designed as a multicentre, open-label, phase III, parallel-arms study, is the first randomized study to compare induction chemotherapy followed by neoadjuvant chemo(re)irradiation and surgery with neoadjuvant chemo(re)irradiation and surgery alone in patients with locally recurrent rectal cancer, with the aim of improving the number of R0 resections.
dc.description.statementofresponsibilityE. L. K. Voogt ... H. M. Kroon ... T. Sammour ... et al. (PelvEx Collaborative)
dc.identifier.citationBJS Open, 2021; 5(3):zrab029-1-zrab029-10
dc.identifier.doi10.1093/bjsopen/zrab029
dc.identifier.issn2474-9842
dc.identifier.issn2474-9842
dc.identifier.orcidKroon, H.M. [0000-0002-8923-7527]
dc.identifier.orcidSammour, T. [0000-0002-4918-8871]
dc.identifier.urihttps://hdl.handle.net/2440/140001
dc.language.isoen
dc.publisherOxford University Press
dc.rights© The Author(s) 2021. Published by Oxford University Press on behalf of BJS Society Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
dc.source.urihttps://doi.org/10.1093/bjsopen/zrab029
dc.subjectInduction Chemotherapy
dc.subject.meshHumans
dc.subject.meshRectal Neoplasms
dc.subject.meshNeoplasm Recurrence, Local
dc.subject.meshAntineoplastic Combined Chemotherapy Protocols
dc.subject.meshNeoadjuvant Therapy
dc.subject.meshQuality of Life
dc.subject.meshMulticenter Studies as Topic
dc.subject.meshRandomized Controlled Trials as Topic
dc.subject.meshChemoradiotherapy
dc.subject.meshInduction Chemotherapy
dc.titleInduction chemotherapy followed by chemoradiotherapy versus chemoradiotherapy alone as neoadjuvant treatment for locally recurrent rectal cancer: study protocol of a multicentre, open-label, parallel-arms, randomized controlled study (PelvEx II)
dc.typeJournal article
pubs.publication-statusPublished

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