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@article{Voogt:2021:bjsopen/zrab029,
author = {Voogt, ELK and Nordkamp, S and Aalbers, AGJ and Buffart, T and Creemers, GJ and Marijnen, CAM and Verhoef, C and Havenga, K and Holman, FA and Kusters, M and Marinelli, AWKS and Melenhorst, J and Aziz, NA and Abecasis, N and Abraham-Nordling, M and Akiyoshi, T and Alberda, W and Albert, M and Andric, M and Angenete, E and Antoniou, A and Auer, R and Austin, KK and Aziz, O and Baker, RP and Bali, M and Baseckas, G and Bebington, B and Bedford, M and Bednarski, BK and Beets, GL and Beets-Tan, RGH and Berbee, M and Berg, J and Berg, PL and Beynon, J and Biondo, S and Bloemen, JG and Boyle, K and Bordeianou, L and Bremers, AB and Brunner, M and Buchwald, P and Bui, A and Burgess, A and Burling, D and Burns, E and Campain, N and Carvalhal, S and Castro, L and Caycedo-Marulanda, A and Ceha, HM and Chan, KKL and Chang, GJ and Chang, M and Chew, MH and Chok, AK and Chong, P and Christensen, HK and Clouston, H and Codd, M and Collins, D and Colquhoun, AJ and Corr, A and Coscia, M and Cosimelli,},
doi = {bjsopen/zrab029},
journal = {BJS Open},
pages = {1--10},
title = {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)},
url = {http://dx.doi.org/10.1093/bjsopen/zrab029},
volume = {5},
year = {2021}
}

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TY  - JOUR
AB  - BackgroundA 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.MethodsThis 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.DiscussionThis 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
AU  - Voogt,ELK
AU  - Nordkamp,S
AU  - Aalbers,AGJ
AU  - Buffart,T
AU  - Creemers,GJ
AU  - Marijnen,CAM
AU  - Verhoef,C
AU  - Havenga,K
AU  - Holman,FA
AU  - Kusters,M
AU  - Marinelli,AWKS
AU  - Melenhorst,J
AU  - Aziz,NA
AU  - Abecasis,N
AU  - Abraham-Nordling,M
AU  - Akiyoshi,T
AU  - Alberda,W
AU  - Albert,M
AU  - Andric,M
AU  - Angenete,E
AU  - Antoniou,A
AU  - Auer,R
AU  - Austin,KK
AU  - Aziz,O
AU  - Baker,RP
AU  - Bali,M
AU  - Baseckas,G
AU  - Bebington,B
AU  - Bedford,M
AU  - Bednarski,BK
AU  - Beets,GL
AU  - Beets-Tan,RGH
AU  - Berbee,M
AU  - Berg,J
AU  - Berg,PL
AU  - Beynon,J
AU  - Biondo,S
AU  - Bloemen,JG
AU  - Boyle,K
AU  - Bordeianou,L
AU  - Bremers,AB
AU  - Brunner,M
AU  - Buchwald,P
AU  - Bui,A
AU  - Burgess,A
AU  - Burling,D
AU  - Burns,E
AU  - Campain,N
AU  - Carvalhal,S
AU  - Castro,L
AU  - Caycedo-Marulanda,A
AU  - Ceha,HM
AU  - Chan,KKL
AU  - Chang,GJ
AU  - Chang,M
AU  - Chew,MH
AU  - Chok,AK
AU  - Chong,P
AU  - Christensen,HK
AU  - Clouston,H
AU  - Codd,M
AU  - Collins,D
AU  - Colquhoun,AJ
AU  - Corr,A
AU  - Coscia,M
AU  - Cosimelli,M
AU  - Coyne,PE
AU  - Crobach,ASLP
AU  - Crolla,RMPH
AU  - Croner,RS
AU  - Damjanovic,L
AU  - Daniels,IR
AU  - Davies,M
AU  - Davies,RJ
AU  - Delaney,CP
AU  - de,Roos MAJ
AU  - de,Wilt JHW
AU  - den,Hartogh MD
AU  - Denost,Q
AU  - Deseyne,P
AU  - Deutsch,C
AU  - Cappel,RDVTN
AU  - de,Vries M
AU  - Dieters,M
AU  - Dietz,D
AU  - Domingo,S
AU  - Doukas,M
AU  - Dozois,EJ
AU  - Duff,M
AU  - Eglinton,T
AU  - Enrique-Navascues,JM
AU  - Espin-Basany,E
AU  - Evans,MD
AU  - Eyjolfsdottir,B
AU  - Fahy,M
AU  - Fearnhead,NS
AU  - Feshtali,S
AU  - Flatmark,K
AU  - Fleming,F
AU  - Folkesson,J
AU  - Frizelle,FA
AU  - Frodin,JE
AU  - Gallego,MA
AU  - Garcia-Granero,E
AU  - Garcia-Sabrido,JL
AU  - Geboes,K
AU  - Gentilini,L
AU  - George,ML
AU  - George,V
AU  - Ghouti,L
AU  - Giner,F
AU  - Ginther,N
AU  - Glyn,T
AU  - Glynn,R
AU  - Golda,T
AU  - Grabsch,H
AU  - Griffiths,B
AU  - Harris,DA
AU  - Hagemans,JA
AU  - Hanchanale,V
AU  - Harji,DP
AU  - Helewa,RM
AU  - Helgason,H
AU  - Hellawell,G
AU  - Heriot,AG
AU  - Heyman,S
AU  - Hochman,D
AU  - Hoff,C
AU  - Hohenberger,W
AU  - Holm,T
AU  - Hompes,R
AU  - Horsthuis,K
AU  - Hospers,G
AU  - Houwers,J
AU  - Iversen,H
AU  - Jenkins,JT
AU  - Kaffenberger,S
AU  - Kandaswamy,G
AU  - Kapur,S
AU  - Kanemitsu,Y
AU  - Kats-Ugurlu,G
AU  - Kelley,SR
AU  - Keller,DS
AU  - Kelly,ME
AU  - Keymeulen,K
AU  - Khan,MS
AU  - Kim,H
AU  - Kim,HJ
AU  - Koh,CE
AU  - Kok,NFM
AU  - Kokelaar,R
AU  - Kontovounisios,C
AU  - Kristensen,HO
AU  - Kroon,HM
AU  - Kumar,S
AU  - Lago,V
AU  - Lakkis,Z
AU  - Lamberg,T
AU  - Larsen,SG
AU  - Larson,DW
AU  - Law,WL
AU  - Laurberg,S
AU  - Lee,PJ
AU  - Leseman-Hoogenboom,MM
AU  - Limbert,M
AU  - Lydrup,ML
AU  - Lyons,A
AU  - Lynch,AC
AU  - Mantyh,C
AU  - Mathis,KL
AU  - Margues,CFS
AU  - Martling,A
AU  - Meijer,OWM
AU  - Meijerink,WJH
DO  - bjsopen/zrab029
EP  - 10
PY  - 2021///
SN  - 2474-9842
SP  - 1
TI  - 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)
T2  - BJS Open
UR  - http://dx.doi.org/10.1093/bjsopen/zrab029
UR  - http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000667756900015&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
UR  - https://academic.oup.com/bjsopen/article/5/3/zrab029/6293963
UR  - http://hdl.handle.net/10044/1/93920
VL  - 5
ER  -

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