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IRIS
Background: 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: Thismulticentre, 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 usingMRI 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 × 1.8Gy in radiotherapy-naive patients, and 15 × 2.0Gy in previously irradiated patients. The concomitant chemotherapy agent will be capecitabine administered twice daily at a dose of 825mg/m2 on radiotherapy days. The primary endpoint of the study is the R0 resection rate. Secondary endpoints are long-termoncological 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.
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)
Voogt E. L. K.;Nordkamp S.;Aalbers A. G. J.;Buffart T.;Creemers G. J.;Marijnen C. A. M.;Verhoef C.;Havenga K.;Holman F. A.;Kusters M.;Marinelli A. W. K. S.;Melenhorst J.;Abdul Aziz N.;Abecasis N.;Abraham-Nordling M.;Akiyoshi T.;Alberda W.;Albert M.;Andric M.;Angenete E.;Antoniou A.;Auer R.;Austin K. K.;Aziz O.;Baker R. P.;Bali M.;Baseckas G.;Bebington B.;Bedford M.;Bednarski B. K.;Beets G. L.;Beets-Tan R. G. H.;Berbee M.;Berg J.;Berg P. L.;Beynon J.;Biondo S.;Bloemen J. G.;Boyle K.;Bordeianou L.;Bremers A. B.;Brunner M.;Buchwald P.;Bui A.;Burgess A.;Burling D.;Burns E.;Campain N.;Carvalhal S.;Castro L.;Caycedo-Marulanda A.;Ceha H. M.;Chan K. K. L.;Chang G. J.;Chang M.;Chew M. H.;Chok A. K.;Chong P.;Christensen H. K.;Clouston H.;Codd M.;Collins D.;Colquhoun A. J.;Corr A.;Coscia M.;Cosimelli M.;Coyne P. E.;Crobach A. S. L. P.;Crolla R. M. P. H.;Croner R. S.;Damjanovic L.;Daniels I. R.;Davies M.;Davies R. J.;Delaney C. P.;De Roos M. A. J.;De Wilt J. H. W.;Den Hartogh M. D.;Denost Q.;Deseyne P.;Deutsch C.;De Vos Tot Nederveen Cappel R.;De Vries M.;Dieters M.;Dietz D.;Domingo S.;Doukas M.;Dozois E. J.;Duff M.;Eglinton T.;Enrique-Navascues J. M.;Espin-Basany E.;Evans M. D.;Eyjolfsdottir B.;Fahy M.;Fearnhead N. S.;Feshtali S.;Flatmark K.;Fleming F.;Folkesson J.;Frizelle F. A.;Frodin J. E.;Gallego M. A.;Garcia-Granero E.;Garcia-Sabrido J. L.;Geboes K.;Gentilini L.;George M. L.;George V.;Ghouti L.;Giner F.;Ginther N.;Glyn T.;Glynn R.;Golda T.;Grabsch H. I.;Griffiths B.;Harris D. A.;Hagemans J. A. W.;Hanchanale V.;Harji D. P.;Helewa R. M.;Helgason H.;Hellawell G.;Heriot A. G.;Heyman S.;Hochman D.;Hoff C.;Hohenberger W.;Holm T.;Hompes R.;Horsthuis K.;Hospers G.;Houwers J.;Iversen H.;Jenkins J. T.;Kaffenberger S.;Kandaswamy G. V.;Kapur S.;Kanemitsu Y.;Kats-Ugurlu G.;Kelley S. R.;Keller D. S.;Kelly M. E.;Keymeulen K.;Khan M. S.;Kim H.;Kim H. J.;Koh C. E.;Kok N. F. M.;Kokelaar R.;Kontovounisios C.;Kristensen H. O.;Kroon H. M.;Kumar S.;Lago V.;Lakkis Z.;Lamberg T.;Larsen S. G.;Larson D. W.;Law W. L.;Laurberg S.;Lee P. J.;Leseman-Hoogenboom M. M.;Limbert M.;Lydrup M. L.;Lyons A.;Lynch A. C.;Mantyh C.;Mathis K. L.;Margues C. F. S.;Martling A.;Meijer O. W. M.;Meijerink W. J. H. J.;Merchea A.;Merkel S.;Mehta A. M.;Mcarthur D. R.;Mcdermott F. D.;Mcgrath J. S.;Malde S.;Mirnezami A.;Monson J. R. T.;Morton J. R.;Nederend J.;Negoi I.;Neto J. W. M.;Ng J. L.;Nguyen B.;Nielsen M. B.;Nieuwenhuijzen G. A. P.;Nilsson P. J.;Nilsson M. L.;Oei S.;Oliver A.;O'dwyer S. T.;Oppedijk V.;Palmer G.;Pappou E.;Park J.;Patsouras D.;Pellino G.;Peterson A. C.;Peulen H. M. U.;Poggioli G.;Proud D.;Quinn M.;Quyn A.;Rajendran N.;Radwan R. W.;Rasheed S.;Rasmussen P. C.;Rausa E.;Regenbogen S. E.;Renehan A.;Richir M. C.;Rocha R.;Rochester M.;Rohila J.;Rothbarth J.;Rottoli M.;Roxburgh C.;Rozema T.;Safar B.;Sagar P. M.;Sahai A.;Saklani A.;Sammour T.;Sayyed R.;Schizas A. M. P.;Schwarzkopf E.;Scripcariu V.;Selvasekar C.;Shaikh I.;Shida D.;Simpson A.;Skeie-Jensen T.;Slangen J. J. G.;Smart N. J.;Smart P.;Smith J. J.;Snaebjornsson P.;Solbakken A. M.;Solomon M. J.;Sorensen M. M.;Sorrentino L.;Speetjens F. M.;Spillenaar Bilgen E. J.;Steele S. R.;Steffens D.;Stitzenberg K.;Stocchi L.;Stylianides N. A.;Swartling T.;Sumrien H.;Sutton P. A.;Swartking T.;Tan E. J.;Taylor C.;Tekkis P. P.;Teras J.;Terpstra V.;Thurairaja R.;Toh E. L.;Tsarkov P.;Tsukada Y.;Tsukamoto S.;Tuech J. J.;Turner W. H.;Tuynman J. B.;Van Duyn E. B.;Van Grevenstein W. M. U.;Van Grieken N. C. T.;Van Iersel L.;Van Lijnschoten G.;Van Meerten E.;Van Ramshorst G. H.;Van Westreenen H. L.;Van Zoggel D.;Vasquez-Jimenez W.;Velema L. A.;Verdaasdonk E.;Verheul H. M. W.;Versteeg K. S.;Vizzielli G.;Uehara K.;Wakeman C.;Warrier S.;Wasmuth H. H.;Weber K.;Weiser M. R.;Wheeler J. M. D.;Wijffels N. A. T.;Wild J.;Willems J. M. W. E.;Wilson M.;Winter D. C.;Wolthuis A.;Wumkes M. L.;Yano H.;Yip B.;Yip J.;Yoo R. N.;Zappa M. A.;Zimmerman D. D. E.;Rutten H. J. T.;Burger J. W. A.
2021-01-01
Abstract
Background: 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: Thismulticentre, 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 usingMRI 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 × 1.8Gy in radiotherapy-naive patients, and 15 × 2.0Gy in previously irradiated patients. The concomitant chemotherapy agent will be capecitabine administered twice daily at a dose of 825mg/m2 on radiotherapy days. The primary endpoint of the study is the R0 resection rate. Secondary endpoints are long-termoncological 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.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11390/1255298
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simulazione ASN
Il report seguente simula gli indicatori relativi alla propria produzione scientifica in relazione alle soglie ASN 2023-2025 del proprio SC/SSD. Si ricorda che il superamento dei valori soglia (almeno 2 su 3) è requisito necessario ma non sufficiente al conseguimento dell'abilitazione. La simulazione si basa sui dati IRIS e sugli indicatori bibliometrici alla data indicata e non tiene conto di eventuali periodi di congedo obbligatorio, che in sede di domanda ASN danno diritto a incrementi percentuali dei valori. La simulazione può differire dall'esito di un’eventuale domanda ASN sia per errori di catalogazione e/o dati mancanti in IRIS, sia per la variabilità dei dati bibliometrici nel tempo. Si consideri che Anvur calcola i valori degli indicatori all'ultima data utile per la presentazione delle domande.
La presente simulazione è stata realizzata sulla base delle specifiche raccolte sul tavolo ER del Focus Group IRIS coordinato dall’Università di Modena e Reggio Emilia e delle regole riportate nel DM 589/2018 e allegata Tabella A. Cineca, l’Università di Modena e Reggio Emilia e il Focus Group IRIS non si assumono alcuna responsabilità in merito all’uso che il diretto interessato o terzi faranno della simulazione. Si specifica inoltre che la simulazione contiene calcoli effettuati con dati e algoritmi di pubblico dominio e deve quindi essere considerata come un mero ausilio al calcolo svolgibile manualmente o con strumenti equivalenti.
