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Volumn 16, Issue 1, 2015, Pages

RandomizEd controlled trial for pre-operAtive dose-escaLation BOOST in locally advanced rectal cancer (RECTAL BOOST study): Study protocol for a randomized controlled trial

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CAPECITABINE;

EID: 84924406162     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-015-0586-4     Document Type: Article
Times cited : (59)

References (34)
  • 1
    • 84924393636 scopus 로고    scopus 로고
    • World Health Organization. GLOBOCAN 2012: Estimated cancer incidence, mortality and prevalence worldwide in 2012. Accessed 14 Feb 2015.
    • International Agency for Research on Cancer, World Health Organization. GLOBOCAN 2012: Estimated cancer incidence, mortality and prevalence worldwide in 2012. http://globocan.iarc.fr/Pages/fact_sheets_population.aspx. Accessed 14 Feb 2015.
  • 2
    • 84924393635 scopus 로고    scopus 로고
    • Cancer statistics in the Netherlands. 2013.Accessed 14 Feb 2015.
    • Netherlands Cancer Registry. Cancer statistics in the Netherlands. 2013. http://www.cijfersoverkanker.nl/. Accessed 14 Feb 2015.
  • 3
    • 77956185901 scopus 로고    scopus 로고
    • Long-term outcome in patients with a pathological complete response after chemoradiation for rectal cancer: a pooled analysis of individual patient data
    • Maas M, Nelemans PJ, Valentini V, Das P, Rödel C, Kuo LJ, et al. Long-term outcome in patients with a pathological complete response after chemoradiation for rectal cancer: a pooled analysis of individual patient data. Lancet Oncol. 2010;11:835-44.
    • (2010) Lancet Oncol. , vol.11 , pp. 835-844
    • Maas, M.1    Nelemans, P.J.2    Valentini, V.3    Das, P.4    Rödel, C.5    Kuo, L.J.6
  • 4
    • 39049169018 scopus 로고    scopus 로고
    • Chemoradiotherapy for rectal cancer: an updated analysis of factors affecting pathological response
    • Sanghera P, Wong DW, McConkey CC, Geh JI, Hartley A. Chemoradiotherapy for rectal cancer: an updated analysis of factors affecting pathological response. Clin Oncol (R Coll Radiol). 2008;20:176-83.
    • (2008) Clin Oncol (R Coll Radiol). , vol.20 , pp. 176-183
    • Sanghera, P.1    Wong, D.W.2    McConkey, C.C.3    Geh, J.I.4    Hartley, A.5
  • 5
    • 0028305674 scopus 로고
    • Pathologic assessment of tumor regression after preoperative chemoradiotherapy of esophageal carcinoma: clinicopathologic correlations
    • Mandard AM, Dalibard F, Mandard JC, Marnay J, Henry-Amar M, Petiot JF, et al. Pathologic assessment of tumor regression after preoperative chemoradiotherapy of esophageal carcinoma: clinicopathologic correlations. Cancer. 1994;73:2680-6.
    • (1994) Cancer. , vol.73 , pp. 2680-2686
    • Mandard, A.M.1    Dalibard, F.2    Mandard, J.C.3    Marnay, J.4    Henry-Amar, M.5    Petiot, J.F.6
  • 6
    • 84915735921 scopus 로고    scopus 로고
    • Impact of radiotherapy boost on pathological complete response in patients with locally advanced rectal cancer: a systematic review and meta-analysis
    • Burbach JP, den Harder AM, Intven M, van Vulpen M, Verkooijen HM, Reerink O. Impact of radiotherapy boost on pathological complete response in patients with locally advanced rectal cancer: a systematic review and meta-analysis. Radiother Oncol. 2014;113:1-9.
    • (2014) Radiother Oncol. , vol.113 , pp. 1-9
    • Burbach, J.P.1    Harder, A.M.2    Intven, M.3    Vulpen, M.4    Verkooijen, H.M.5    Reerink, O.6
  • 7
    • 84857993166 scopus 로고    scopus 로고
    • The CARTS study: chemoradiation therapy for rectal cancer in the distal rectum followed by organ-sparing transanal endoscopic microsurgery
    • Bökkerink GMJ, de Graaf EJ, Punt CJ, Nagtegaal ID, Rütten H, Nuyttens JJ, et al. The CARTS study: chemoradiation therapy for rectal cancer in the distal rectum followed by organ-sparing transanal endoscopic microsurgery. BMC Surg. 2011;11:34.
    • (2011) BMC Surg. , vol.11 , pp. 34
    • Bökkerink, G.M.J.1    Graaf, E.J.2    Punt, C.J.3    Nagtegaal, I.D.4    Rütten, H.5    Nuyttens, J.J.6
  • 8
    • 84888354365 scopus 로고    scopus 로고
    • Local excision after preoperative chemoradiotherapy for rectal cancer: results of a multicenter phase II clinical trial
    • Pucciarelli S, De Paoli A, Guerrieri M, La Torre G, Maretto I, De Marchi F, et al. Local excision after preoperative chemoradiotherapy for rectal cancer: results of a multicenter phase II clinical trial. Dis Colon Rectum. 2013;56:1349-56.
    • (2013) Dis Colon Rectum. , vol.56 , pp. 1349-1356
    • Pucciarelli, S.1    Paoli, A.2    Guerrieri, M.3    Torre, G.4    Maretto, I.5    Marchi, F.6
  • 9
    • 84924393634 scopus 로고    scopus 로고
    • ISRCTN Registry ISRCTN14422743. Transanal endoscopic microsurgery (TEM) and Radiotherapy in Early rectal Cancer: a randomised phase II feasibility study. Accessed 14 Feb 2015
    • ISRCTN Registry ISRCTN14422743. Transanal endoscopic microsurgery (TEM) and Radiotherapy in Early rectal Cancer: a randomised phase II feasibility study. http://www.controlled-trials.com/ISRCTN14422743/. Accessed 14 Feb 2015.
  • 11
    • 84870050038 scopus 로고    scopus 로고
    • Nonoperative management of rectal cancer with complete clinical response after neoadjuvant therapy
    • Smith JD, Ruby JA, Goodman KA, Saltz LB, Guillem JG, Weiser MR, et al. Nonoperative management of rectal cancer with complete clinical response after neoadjuvant therapy. Ann Surg. 2012;256:965-72.
    • (2012) Ann Surg. , vol.256 , pp. 965-972
    • Smith, J.D.1    Ruby, J.A.2    Goodman, K.A.3    Saltz, L.B.4    Guillem, J.G.5    Weiser, M.R.6
  • 12
    • 84896708427 scopus 로고    scopus 로고
    • Local recurrence after complete clinical response and watch and wait in rectal cancer after neoadjuvant chemoradiation: impact of salvage therapy on local disease control
    • Habr-Gama A, Gama-Rodrigues J, São Julião GP, Proscurshim I, Sabbagh C, Lynn PB, et al. Local recurrence after complete clinical response and watch and wait in rectal cancer after neoadjuvant chemoradiation: impact of salvage therapy on local disease control. Int J Radiat Oncol Biol Phys. 2014;88:822-8.
    • (2014) Int J Radiat Oncol Biol Phys. , vol.88 , pp. 822-828
    • Habr-Gama, A.1    Gama-Rodrigues, J.2    São Julião, G.P.3    Proscurshim, I.4    Sabbagh, C.5    Lynn, P.B.6
  • 13
    • 84889888543 scopus 로고    scopus 로고
    • Quantified pathologic response assessed as residual tumor burden is a predictor of recurrence-free survival in patients with rectal cancer who undergo resection after neoadjuvant chemoradiotherapy
    • Agarwal A, Chang GJ, Hu CY, Taggart M, Rashid A, Park IJ, et al. Quantified pathologic response assessed as residual tumor burden is a predictor of recurrence-free survival in patients with rectal cancer who undergo resection after neoadjuvant chemoradiotherapy. Cancer. 2013;119:4231-41.
    • (2013) Cancer. , vol.119 , pp. 4231-4241
    • Agarwal, A.1    Chang, G.J.2    Hu, C.Y.3    Taggart, M.4    Rashid, A.5    Park, I.J.6
  • 14
    • 84862775402 scopus 로고    scopus 로고
    • Systematic review and meta-analysis of outcomes following pathological complete response to neoadjuvant chemoradiotherapy for rectal cancer
    • Martin ST, Heneghan HM, Winter DC. Systematic review and meta-analysis of outcomes following pathological complete response to neoadjuvant chemoradiotherapy for rectal cancer. Br J Surg. 2012;99:918-28.
    • (2012) Br J Surg. , vol.99 , pp. 918-928
    • Martin, S.T.1    Heneghan, H.M.2    Winter, D.C.3
  • 15
    • 84867402398 scopus 로고    scopus 로고
    • Complete pathologic response after combined modality treatment for rectal cancer and long-term survival: a meta-analysis
    • Zorcolo L, Rosman AS, Restivo A, Pisano M, Nigri GR, Fancellu A, et al. Complete pathologic response after combined modality treatment for rectal cancer and long-term survival: a meta-analysis. Ann Surg Oncol. 2012;19:2822-32.
    • (2012) Ann Surg Oncol. , vol.19 , pp. 2822-2832
    • Zorcolo, L.1    Rosman, A.S.2    Restivo, A.3    Pisano, M.4    Nigri, G.R.5    Fancellu, A.6
  • 16
    • 84924393633 scopus 로고    scopus 로고
    • ClinicalTrials.gov NCT02070146. The PICNIC Project: a ProspectIve Data CollectioN Initiative on Colorectal Cancer. Accessed 14 Feb 2015.
    • ClinicalTrials.gov NCT02070146. The PICNIC Project: a ProspectIve Data CollectioN Initiative on Colorectal Cancer. http://clinicaltrials.gov/show/NCT02070146. Accessed 14 Feb 2015.
  • 17
    • 77951709226 scopus 로고    scopus 로고
    • Rethinking pragmatic randomised controlled trials: introducing the "cohort multiple randomised controlled trial" design
    • Relton C, Torgerson D, O'Cathain A, Nicholl J. Rethinking pragmatic randomised controlled trials: introducing the "cohort multiple randomised controlled trial" design. BMJ. 2010;340:c1066.
    • (2010) BMJ. , vol.340 , pp. c1066
    • Relton, C.1    Torgerson, D.2    O'Cathain, A.3    Nicholl, J.4
  • 18
    • 0030692092 scopus 로고    scopus 로고
    • TNM Classification of malignant tumors. Fifth edition (1997). Union internationale contre le cancer and the American joint committee on cancer
    • Sobin LH, Fleming ID. TNM Classification of malignant tumors. Fifth edition (1997). Union internationale contre le cancer and the American joint committee on cancer. Cancer. 1997;80:1803-4.
    • (1997) Cancer , vol.80 , pp. 1803-1804
    • Sobin, L.H.1    Fleming, I.D.2
  • 19
    • 84924393632 scopus 로고    scopus 로고
    • Dutch National Guidelines for Oncological Care: colorectal carcinoma. Version 3.0. Dutch. Accessed 14 Feb 2015.
    • Dutch National Guidelines for Oncological Care: colorectal carcinoma. Version 3.0. Dutch. http://www.oncoline.nl/colorectaalcarcinoom. Accessed 14 Feb 2015.
  • 21
  • 22
    • 84874098337 scopus 로고    scopus 로고
    • Diffusion-weighted MRI in locally advanced rectal cancer: pathological response prediction after neo-adjuvant radiochemotherapy
    • Intven M, Reerink O, Philippens ME. Diffusion-weighted MRI in locally advanced rectal cancer: pathological response prediction after neo-adjuvant radiochemotherapy. Strahlenther Onkol. 2013;189:117-22.
    • (2013) Strahlenther Onkol. , vol.189 , pp. 117-122
    • Intven, M.1    Reerink, O.2    Philippens, M.E.3
  • 24
    • 84924393631 scopus 로고    scopus 로고
    • MRI-based inter-fraction motion analysis for rectal cancer boost radiotherapy [abstract OC-0574]. In Proceedings of the European Society for Radiotherapy & Oncology: ESTRO 33; 4-8 Apr 2014; Vienna, Austria.
    • Kleijnen JJE, Van Asselen B, Burbach JPM, Intven M, Reerink O, Lagendijk JJW, et al. MRI-based inter-fraction motion analysis for rectal cancer boost radiotherapy [abstract OC-0574]. In Proceedings of the European Society for Radiotherapy & Oncology: ESTRO 33; 4-8 Apr 2014; Vienna, Austria.
    • Kleijnen, J.J.E.1    Van Asselen, B.2    Burbach, J.P.M.3    Intven, M.4    Reerink, O.5    Lagendijk, J.J.W.6
  • 25
    • 33845670862 scopus 로고    scopus 로고
    • Reporting colorectal cancer
    • Quirke P, Morris E. Reporting colorectal cancer. Histopathology. 2007;50:103-12.
    • (2007) Histopathology. , vol.50 , pp. 103-112
    • Quirke, P.1    Morris, E.2
  • 26
    • 84924393630 scopus 로고    scopus 로고
    • National Institutes of Health. Common Terminology Criteria for Adverse Events (CTCAE) v.4 data files.] Accessed 14 Feb 2015.
    • National Cancer Institute, National Institutes of Health. Common Terminology Criteria for Adverse Events (CTCAE) v.4 data files. http://evs.nci.nih.gov/ftp1/CTCAE/About.html] Accessed 14 Feb 2015.
  • 27
    • 0027417437 scopus 로고
    • The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology
    • Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85:365-76.
    • (1993) J Natl Cancer Inst. , vol.85 , pp. 365-376
    • Aaronson, N.K.1    Ahmedzai, S.2    Bergman, B.3    Bullinger, M.4    Cull, A.5    Duez, N.J.6
  • 28
    • 34250223069 scopus 로고    scopus 로고
    • Assessing quality of life in patients with colorectal cancer: an update of the EORTC quality of life questionnaire
    • Gujral S, Conroy T, Fleissner C, Sezer O, King PM, Avery KN, et al. Assessing quality of life in patients with colorectal cancer: an update of the EORTC quality of life questionnaire. Eur J Cancer. 2007;43:1564-73.
    • (2007) Eur J Cancer. , vol.43 , pp. 1564-1573
    • Gujral, S.1    Conroy, T.2    Fleissner, C.3    Sezer, O.4    King, P.M.5    Avery, K.N.6
  • 29
    • 70350599789 scopus 로고    scopus 로고
    • Clinical and psychometric validation of the EORTC QLQ-CR29 questionnaire module to assess health-related quality of life in patients with colorectal cancer
    • Whistance RN, Conroy T, Chie W, Costantini A, Sezer O, Koller M, et al. Clinical and psychometric validation of the EORTC QLQ-CR29 questionnaire module to assess health-related quality of life in patients with colorectal cancer. Eur J Cancer. 2009;45:3017-26.
    • (2009) Eur J Cancer. , vol.45 , pp. 3017-3026
    • Whistance, R.N.1    Conroy, T.2    Chie, W.3    Costantini, A.4    Sezer, O.5    Koller, M.6
  • 30
    • 84871371270 scopus 로고    scopus 로고
    • Radiation dose-response model for locally advanced rectal cancer after preoperative chemoradiation therapy
    • Appelt AL, Ploen J, Vogelius IR, Bentzen SM, Jakobsen A. Radiation dose-response model for locally advanced rectal cancer after preoperative chemoradiation therapy. Int J Radiat Oncol Biol Phys. 2013;85:74-80.
    • (2013) Int J Radiat Oncol Biol Phys. , vol.85 , pp. 74-80
    • Appelt, A.L.1    Ploen, J.2    Vogelius, I.R.3    Bentzen, S.M.4    Jakobsen, A.5
  • 31
    • 70649115889 scopus 로고    scopus 로고
    • Employing complier average causal effect analytic methods to examine effects of randomized encouragement trials
    • Connell AM. Employing complier average causal effect analytic methods to examine effects of randomized encouragement trials. Am J Drug Alcohol Abuse. 2009;35:253-9.
    • (2009) Am J Drug Alcohol Abuse. , vol.35 , pp. 253-259
    • Connell, A.M.1
  • 32
    • 12344325624 scopus 로고    scopus 로고
    • Analysis and interpretation of health-related quality-of-life data from clinical trials: basic approach of the National Cancer Institute of Canada Clinical Trials Group
    • Osoba D, Bezjak A, Brundage M, Zee B, Tu D, Pater J, et al. Analysis and interpretation of health-related quality-of-life data from clinical trials: basic approach of the National Cancer Institute of Canada Clinical Trials Group. Eur J Cancer. 2005;41:280-7.
    • (2005) Eur J Cancer. , vol.41 , pp. 280-287
    • Osoba, D.1    Bezjak, A.2    Brundage, M.3    Zee, B.4    Tu, D.5    Pater, J.6
  • 33
    • 84924393629 scopus 로고    scopus 로고
    • ClinicalTrials.gov NCT01951521. RandomizEd Controlled Trial for Pre-operAtive Dose-escaLation BOOST in Locally Advanced Rectal Cancer (RECTAL BOOST study). http://clinicaltrials.gov/show/NCT01951521. Accessed 13 Feb 2015.
  • 34
    • 2942750356 scopus 로고    scopus 로고
    • Improved sphincter preservation in low rectal cancer with high-dose preoperative radiotherapy: the Lyon R96-02 randomized trial
    • Gerard JP, Chapet O, Nemoz C, Hartweig J, Romestaing P, Coquard R, et al. Improved sphincter preservation in low rectal cancer with high-dose preoperative radiotherapy: the Lyon R96-02 randomized trial. J Clin Oncol. 2004;22:2404-9.
    • (2004) J Clin Oncol. , vol.22 , pp. 2404-2409
    • Gerard, J.P.1    Chapet, O.2    Nemoz, C.3    Hartweig, J.4    Romestaing, P.5    Coquard, R.6


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