| 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) |
| Authors: |
Voogt, ELK; Nordkamp, S; Aalbers, AGJ; Buffart, T; Creemers, GJ; Marijnen, CAM; Verhoef, C; Havenga, K; Holman, FA; Kusters, M; Marinelli, AWKS; Melenhorst, J; Aziz, NA; Abecasis, N; Abraham-Nordling, M; Akiyoshi, T; Alberda, W; Albert, M; Andric, M; Angenete, E; Antoniou, A; Auer, R; Austin, KK; Aziz, O; Baker, RP; Bali, M; Baseckas, G; Bebington, B; Bedford, M; Bednarski, BK; Beets, GL; Beets-Tan, RGH; Berbee, M; Berg, J; Berg, PL; Beynon, J; Biondo, S; Bloemen, JG; Boyle, K; Bordeianou, L; Bremers, AB; Brunner, M; Buchwald, P; Bui, A; Burgess, A; Burling, D; Burns, E; Campain, N; Carvalhal, S; Castro, L; Caycedo-Marulanda, A; Ceha, HM; Chan, KKL; Chang, GJ; Chang, M; Chew, MH; Chok, AK; Chong, P; Christensen, HK; Clouston, H; Codd, M; Collins, D; Colquhoun, AJ; Corr, A; Coscia, M; Cosimelli, M; Coyne, PE; Crobach, ASLP; Crolla, RMPH; Croner, RS; Damjanovic, L; Daniels, IR; Davies, M; Davies, RJ; Delaney, CP; De Roos, MAJ; De Wilt, JHW; Den Hartogh, MD; Denost, Q; Deseyne, P; Deutsch, C; Cappel, RDVTN; De Vries, M; Dieters, M; Dietz, D; Domingo, S; Doukas, M; Dozois, EJ; Duff, M; Eglinton, T; Enrique-Navascues, JM; Espin-Basany, E; Evans, MD; Eyjolfsdottir, B; Fahy, M; Fearnhead, NS; Feshtali, S; Flatmark, K; Fleming, F; Folkesson, J; Frizelle, FA; Frodin, JE; Gallego, MA; Garcia-Granero, E; Garcia-Sabrido, JL; Geboes, K; Gentilini, L; George, ML; George, V; Ghouti, L; Giner, F; Ginther, N; Glyn, T; Glynn, R; Golda, T; Grabsch, H; Griffiths, B; Harris, DA; Hagemans, JA; Hanchanale, V; Harji, DP; Helewa, RM; Helgason, H; Hellawell, G; Heriot, AG; Heyman, S; Hochman, D; Hoff, C; Hohenberger, W; Holm, T; Hompes, R; Horsthuis, K; Hospers, G; Houwers, J; Iversen, H; Jenkins, JT; Kaffenberger, S; Kandaswamy, G; Kapur, S; Kanemitsu, Y; Kats-Ugurlu, G; Kelley, SR; Keller, DS; Kelly, ME; Keymeulen, K; Khan, MS; Kim, H; Kim, HJ; Koh, CE; Kok, NFM; Kokelaar, R; Kontovounisios, C; Kristensen, HO; Kroon, HM; Kumar, S; Lago, V; Lakkis, Z; Lamberg, T; Larsen, SG; Larson, DW; Law, WL; Laurberg, S; Lee, PJ; Leseman-Hoogenboom, MM; Limbert, M; Lydrup, ML; Lyons, A; Lynch, AC; Mantyh, C; Mathis, KL; Margues, CFS; Martling, A; Meijer, OWM; Meijerink, WJHJ; Merchea, A; Merkel, S; Mehta, AM; McArthur, DR; McDermott, FD; McGrath, JS; Malde, S; Mirnezami, A; Monson, JR; Morton, JR; Nederend, J; Negoi, I; Neto, JWM; Ng, JL; Nguyen, B; Nielsen, MB; Nieuwenhuijzen, GAP; Nilsson, PJ; Nilsson, ML; Oei, S; Oliver, A; O'Dwyer, ST; Oppedijk, V; Palmer, G; Pappou, E; Park, J; Patsouras, D; Pellino, G; Peterson, AC; Peulen, HMU; Poggioli, G; Proud, D; Quinn, M; Quyn, A; Rajendran, N; Radwan, RW; Rasheed, S; Rasmussen, PC; Rausa, E; Regenbogen, SE; Renehan, A; Richir, MC; Rocha, R; Rochester, M; Rohila, J; Rothbarth, J; Rottoli, M; Roxburgh, C; Rozema, T; Safar, B; Sagar, PM; Sahai, A; Saklani, A; Sammour, T; Sayyed, R; Schizas, AMP; Schwarzkopf, E; Scripcariu, V; Selvasekar, C; Shaikh, I; Shida, D; Simpson, A; Skeie-Jensen, T; Slangen, JJG; Smart, NJ; Smart, P; Smith, JJ; Snaebjornsson, P; Solbakken, AM; Solomon, MJ; Sorensen, MM; Sorrentino, L; Speetjens, FM; Bilgen, EJS; Steele, SR; Steffens, D; Stitzenberg, K; Stocchi, L; Stylianides, NA; Swartling, T; Sumrien, H; Sutton, PA; Swartking, T; Tan, EJ; Taylor, C; Tekkis, PP; Teras, J; Terpstra, V; Thurairaja, R; Toh, EL; Tsarkov, P; Tsukada, Y; Tsukamoto, S; Tuech, JJ; Turner, WH; Tuynman, JB; Van Duyn, EB; Van Grevenstein, WMU; Van Grieken, NCT; Van Iersel, L; Van Lijnschoten, G; Van Meerten, E; Van Ramshorst, GH; Van Westreenen, HL; Van Zoggel, D; Vasquez-Jimenez, W; Velema, LA; Verdaasdonk, E; Verheul, HMW; Versteeg, KS; Vizzielli, G; Uehara, K; Wakeman, C; Warrier, S; Wasmuth, HH; Weber, K; Weiser, MR; Wheeler, JMD; Wijffels, NAT; Wild, J; Willems, JMWE; Wilson, M; Winter, DC; Wolthuis, A; Wumkes, ML; Yano, H; Yip, B; Yip, J; Yoo, RN; Zappa, MA; Zimmerman, DDE; Rutten, HJT; Burger, JWA |
| Source: |
10 ; 1 |
| Publisher Information: |
Oxford University Press |
| Publication Year: |
2021 |
| Collection: |
Imperial College London: Spiral |
| Subject Terms: |
Science & Technology; Life Sciences & Biomedicine; Surgery; TOTAL MESORECTAL EXCISION; METASTATIC COLORECTAL-CANCER; FOLFOXIRI PLUS BEVACIZUMAB; 1ST-LINE TREATMENT; PHASE-II; CONCOMITANT CHEMORADIOTHERAPY; MULTIMODALITY TREATMENT; POOLED ANALYSIS; OXALIPLATIN; Antineoplastic Combined Chemotherapy Protocols; Chemoradiotherapy; Humans; Induction Chemotherapy; Multicenter Studies as Topic; Neoadjuvant Therapy; Neoplasm Recurrence; Local; Quality of Life; Randomized Controlled Trials as Topic; Rectal Neoplasms; PelvEx Collaborative |
| Description: |
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 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 ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
BJS Open; http://hdl.handle.net/10044/1/93920 |
| DOI: |
10.1093/bjsopen/zrab029 |
| Availability: |
http://hdl.handle.net/10044/1/93920; https://doi.org/10.1093/bjsopen/zrab029 |
| 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. ; http://creativecommons.org/licenses/by/4.0/ |
| Accession Number: |
edsbas.3BD2D2E4 |
| Database: |
BASE |