A phase I dose escalation study of oxaliplatin plus oral S-1 and pelvic radiation in patients with locally advanced rectal cancer (SHOGUN trial)

Background The objective of this phase I study was to determine the maximum tolerated dose (MTD) and recommended dose (RD) of preoperative chemoradiotherapy (CRT) with S-1 plus oxaliplatin in patients with locally advanced rectal cancer. Methods Patients received radiotherapy in a total dose of 50.4...
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Autor*in:	Ishihara, Soichiro [verfasserIn] Matsusaka, Satoshi Kondo, Keisaku Horie, Hisanaga Uehara, Keisuke Oguchi, Masahiko Murofushi, Keiko Ueno, Masashi Mizunuma, Nobuyuki Shinbo, Taijyu Kato, Daiki Okuda, Junji Hashiguchi, Yojiro Nakazawa, Masanori Sunami, Eiji Kawai, Kazushige Yamashita, Hideomi Okada, Tohru Ishikawa, Yuichi Nakajima, Toshifusa Watanabe, Toshiaki

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2015

Schlagwörter:	Rectal cancer Chemoradiotherapy Phase I study Oxaliplatin S-1

Anmerkung:	© Ishihara et al.; licensee BioMed Central. 2015. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (

Übergeordnetes Werk:	Enthalten in: Radiation oncology - London : BioMed Central, 2006, 10(2015), 1 vom: 23. Jan.
Übergeordnetes Werk:	volume:10 ; year:2015 ; number:1 ; day:23 ; month:01

Links:	Volltext

DOI / URN:	10.1186/s13014-015-0333-8

Katalog-ID:	SPR029703921

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245	1	2	\|a A phase I dose escalation study of oxaliplatin plus oral S-1 and pelvic radiation in patients with locally advanced rectal cancer (SHOGUN trial)
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520			\|a Background The objective of this phase I study was to determine the maximum tolerated dose (MTD) and recommended dose (RD) of preoperative chemoradiotherapy (CRT) with S-1 plus oxaliplatin in patients with locally advanced rectal cancer. Methods Patients received radiotherapy in a total dose of 50.4 Gy in 28 fractions. Concurrent chemotherapy consisted of a fixed oral dose of S-1 (80 mg/$ m^{2} $/day) on days 1–5, 8–12, 22–27, and 29–33, plus escalated doses of oxaliplatin as an intravenous infusion on days 1, 8, 22, and 29. Oxaliplatin was initially given in a dose of 40 mg/$ m^{2} $/week to three patients. The dose was then increased in a stepwise fashion to 50 mg/$ m^{2} $/week and the highest dose level of 60 mg/$ m^{2} $/week until the MTD was attained. Results Thirteen patients were enrolled, and 12 received CRT. Dose-limiting toxicity (DLT) occurred in two of six patients (persistent grade 2 neutropenia, delaying oxaliplatin treatment by more than 3 days) at dose level 3; there were no grade 3 or 4 adverse events defined as DLT. The RD was 60 mg/$ m^{2} $/week of oxaliplatin on days 1, 8, 22, and 29. Twelve patients underwent histologically confirmed R0 resections, and two out of six patients (33%) given dose level 3 had pathological complete responses. Conclusions The RD for further studies is 80 mg/$ m^{2} $ of S-1 5 days per week plus 60 mg/$ m^{2} $ of oxaliplatin on days 1, 8, 22, and 29 and concurrent radiotherapy. Although our results are preliminary, this new regimen for neoadjuvant chemoradiotherapy is considered safe and active. Trial registration This trial was registered with Clinicaltrials.gov (identifier: NCT01227239).
650		4	\|a Rectal cancer \|7 (dpeaa)DE-He213
650		4	\|a Chemoradiotherapy \|7 (dpeaa)DE-He213
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700	1		\|a Matsusaka, Satoshi \|4 aut
700	1		\|a Kondo, Keisaku \|4 aut
700	1		\|a Horie, Hisanaga \|4 aut
700	1		\|a Uehara, Keisuke \|4 aut
700	1		\|a Oguchi, Masahiko \|4 aut
700	1		\|a Murofushi, Keiko \|4 aut
700	1		\|a Ueno, Masashi \|4 aut
700	1		\|a Mizunuma, Nobuyuki \|4 aut
700	1		\|a Shinbo, Taijyu \|4 aut
700	1		\|a Kato, Daiki \|4 aut
700	1		\|a Okuda, Junji \|4 aut
700	1		\|a Hashiguchi, Yojiro \|4 aut
700	1		\|a Nakazawa, Masanori \|4 aut
700	1		\|a Sunami, Eiji \|4 aut
700	1		\|a Kawai, Kazushige \|4 aut
700	1		\|a Yamashita, Hideomi \|4 aut
700	1		\|a Okada, Tohru \|4 aut
700	1		\|a Ishikawa, Yuichi \|4 aut
700	1		\|a Nakajima, Toshifusa \|4 aut
700	1		\|a Watanabe, Toshiaki \|4 aut
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allfields	10.1186/s13014-015-0333-8 doi (DE-627)SPR029703921 (SPR)s13014-015-0333-8-e DE-627 ger DE-627 rakwb eng Ishihara, Soichiro verfasserin aut A phase I dose escalation study of oxaliplatin plus oral S-1 and pelvic radiation in patients with locally advanced rectal cancer (SHOGUN trial) 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Ishihara et al.; licensee BioMed Central. 2015. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( Background The objective of this phase I study was to determine the maximum tolerated dose (MTD) and recommended dose (RD) of preoperative chemoradiotherapy (CRT) with S-1 plus oxaliplatin in patients with locally advanced rectal cancer. Methods Patients received radiotherapy in a total dose of 50.4 Gy in 28 fractions. Concurrent chemotherapy consisted of a fixed oral dose of S-1 (80 mg/$ m^{2} $/day) on days 1–5, 8–12, 22–27, and 29–33, plus escalated doses of oxaliplatin as an intravenous infusion on days 1, 8, 22, and 29. Oxaliplatin was initially given in a dose of 40 mg/$ m^{2} $/week to three patients. The dose was then increased in a stepwise fashion to 50 mg/$ m^{2} $/week and the highest dose level of 60 mg/$ m^{2} $/week until the MTD was attained. Results Thirteen patients were enrolled, and 12 received CRT. Dose-limiting toxicity (DLT) occurred in two of six patients (persistent grade 2 neutropenia, delaying oxaliplatin treatment by more than 3 days) at dose level 3; there were no grade 3 or 4 adverse events defined as DLT. The RD was 60 mg/$ m^{2} $/week of oxaliplatin on days 1, 8, 22, and 29. Twelve patients underwent histologically confirmed R0 resections, and two out of six patients (33%) given dose level 3 had pathological complete responses. Conclusions The RD for further studies is 80 mg/$ m^{2} $ of S-1 5 days per week plus 60 mg/$ m^{2} $ of oxaliplatin on days 1, 8, 22, and 29 and concurrent radiotherapy. Although our results are preliminary, this new regimen for neoadjuvant chemoradiotherapy is considered safe and active. Trial registration This trial was registered with Clinicaltrials.gov (identifier: NCT01227239). Rectal cancer (dpeaa)DE-He213 Chemoradiotherapy (dpeaa)DE-He213 Phase I study (dpeaa)DE-He213 Oxaliplatin (dpeaa)DE-He213 S-1 (dpeaa)DE-He213 Matsusaka, Satoshi aut Kondo, Keisaku aut Horie, Hisanaga aut Uehara, Keisuke aut Oguchi, Masahiko aut Murofushi, Keiko aut Ueno, Masashi aut Mizunuma, Nobuyuki aut Shinbo, Taijyu aut Kato, Daiki aut Okuda, Junji aut Hashiguchi, Yojiro aut Nakazawa, Masanori aut Sunami, Eiji aut Kawai, Kazushige aut Yamashita, Hideomi aut Okada, Tohru aut Ishikawa, Yuichi aut Nakajima, Toshifusa aut Watanabe, Toshiaki aut Enthalten in Radiation oncology London : BioMed Central, 2006 10(2015), 1 vom: 23. Jan. (DE-627)508725739 (DE-600)2224965-5 1748-717X nnns volume:10 year:2015 number:1 day:23 month:01 https://dx.doi.org/10.1186/s13014-015-0333-8 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2108 GBV_ILN_2111 GBV_ILN_2119 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 10 2015 1 23 01
spelling	10.1186/s13014-015-0333-8 doi (DE-627)SPR029703921 (SPR)s13014-015-0333-8-e DE-627 ger DE-627 rakwb eng Ishihara, Soichiro verfasserin aut A phase I dose escalation study of oxaliplatin plus oral S-1 and pelvic radiation in patients with locally advanced rectal cancer (SHOGUN trial) 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Ishihara et al.; licensee BioMed Central. 2015. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( Background The objective of this phase I study was to determine the maximum tolerated dose (MTD) and recommended dose (RD) of preoperative chemoradiotherapy (CRT) with S-1 plus oxaliplatin in patients with locally advanced rectal cancer. Methods Patients received radiotherapy in a total dose of 50.4 Gy in 28 fractions. Concurrent chemotherapy consisted of a fixed oral dose of S-1 (80 mg/$ m^{2} $/day) on days 1–5, 8–12, 22–27, and 29–33, plus escalated doses of oxaliplatin as an intravenous infusion on days 1, 8, 22, and 29. Oxaliplatin was initially given in a dose of 40 mg/$ m^{2} $/week to three patients. The dose was then increased in a stepwise fashion to 50 mg/$ m^{2} $/week and the highest dose level of 60 mg/$ m^{2} $/week until the MTD was attained. Results Thirteen patients were enrolled, and 12 received CRT. Dose-limiting toxicity (DLT) occurred in two of six patients (persistent grade 2 neutropenia, delaying oxaliplatin treatment by more than 3 days) at dose level 3; there were no grade 3 or 4 adverse events defined as DLT. The RD was 60 mg/$ m^{2} $/week of oxaliplatin on days 1, 8, 22, and 29. Twelve patients underwent histologically confirmed R0 resections, and two out of six patients (33%) given dose level 3 had pathological complete responses. Conclusions The RD for further studies is 80 mg/$ m^{2} $ of S-1 5 days per week plus 60 mg/$ m^{2} $ of oxaliplatin on days 1, 8, 22, and 29 and concurrent radiotherapy. Although our results are preliminary, this new regimen for neoadjuvant chemoradiotherapy is considered safe and active. Trial registration This trial was registered with Clinicaltrials.gov (identifier: NCT01227239). Rectal cancer (dpeaa)DE-He213 Chemoradiotherapy (dpeaa)DE-He213 Phase I study (dpeaa)DE-He213 Oxaliplatin (dpeaa)DE-He213 S-1 (dpeaa)DE-He213 Matsusaka, Satoshi aut Kondo, Keisaku aut Horie, Hisanaga aut Uehara, Keisuke aut Oguchi, Masahiko aut Murofushi, Keiko aut Ueno, Masashi aut Mizunuma, Nobuyuki aut Shinbo, Taijyu aut Kato, Daiki aut Okuda, Junji aut Hashiguchi, Yojiro aut Nakazawa, Masanori aut Sunami, Eiji aut Kawai, Kazushige aut Yamashita, Hideomi aut Okada, Tohru aut Ishikawa, Yuichi aut Nakajima, Toshifusa aut Watanabe, Toshiaki aut Enthalten in Radiation oncology London : BioMed Central, 2006 10(2015), 1 vom: 23. Jan. (DE-627)508725739 (DE-600)2224965-5 1748-717X nnns volume:10 year:2015 number:1 day:23 month:01 https://dx.doi.org/10.1186/s13014-015-0333-8 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2108 GBV_ILN_2111 GBV_ILN_2119 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 10 2015 1 23 01
allfields_unstemmed	10.1186/s13014-015-0333-8 doi (DE-627)SPR029703921 (SPR)s13014-015-0333-8-e DE-627 ger DE-627 rakwb eng Ishihara, Soichiro verfasserin aut A phase I dose escalation study of oxaliplatin plus oral S-1 and pelvic radiation in patients with locally advanced rectal cancer (SHOGUN trial) 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Ishihara et al.; licensee BioMed Central. 2015. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( Background The objective of this phase I study was to determine the maximum tolerated dose (MTD) and recommended dose (RD) of preoperative chemoradiotherapy (CRT) with S-1 plus oxaliplatin in patients with locally advanced rectal cancer. Methods Patients received radiotherapy in a total dose of 50.4 Gy in 28 fractions. Concurrent chemotherapy consisted of a fixed oral dose of S-1 (80 mg/$ m^{2} $/day) on days 1–5, 8–12, 22–27, and 29–33, plus escalated doses of oxaliplatin as an intravenous infusion on days 1, 8, 22, and 29. Oxaliplatin was initially given in a dose of 40 mg/$ m^{2} $/week to three patients. The dose was then increased in a stepwise fashion to 50 mg/$ m^{2} $/week and the highest dose level of 60 mg/$ m^{2} $/week until the MTD was attained. Results Thirteen patients were enrolled, and 12 received CRT. Dose-limiting toxicity (DLT) occurred in two of six patients (persistent grade 2 neutropenia, delaying oxaliplatin treatment by more than 3 days) at dose level 3; there were no grade 3 or 4 adverse events defined as DLT. The RD was 60 mg/$ m^{2} $/week of oxaliplatin on days 1, 8, 22, and 29. Twelve patients underwent histologically confirmed R0 resections, and two out of six patients (33%) given dose level 3 had pathological complete responses. Conclusions The RD for further studies is 80 mg/$ m^{2} $ of S-1 5 days per week plus 60 mg/$ m^{2} $ of oxaliplatin on days 1, 8, 22, and 29 and concurrent radiotherapy. Although our results are preliminary, this new regimen for neoadjuvant chemoradiotherapy is considered safe and active. Trial registration This trial was registered with Clinicaltrials.gov (identifier: NCT01227239). Rectal cancer (dpeaa)DE-He213 Chemoradiotherapy (dpeaa)DE-He213 Phase I study (dpeaa)DE-He213 Oxaliplatin (dpeaa)DE-He213 S-1 (dpeaa)DE-He213 Matsusaka, Satoshi aut Kondo, Keisaku aut Horie, Hisanaga aut Uehara, Keisuke aut Oguchi, Masahiko aut Murofushi, Keiko aut Ueno, Masashi aut Mizunuma, Nobuyuki aut Shinbo, Taijyu aut Kato, Daiki aut Okuda, Junji aut Hashiguchi, Yojiro aut Nakazawa, Masanori aut Sunami, Eiji aut Kawai, Kazushige aut Yamashita, Hideomi aut Okada, Tohru aut Ishikawa, Yuichi aut Nakajima, Toshifusa aut Watanabe, Toshiaki aut Enthalten in Radiation oncology London : BioMed Central, 2006 10(2015), 1 vom: 23. Jan. (DE-627)508725739 (DE-600)2224965-5 1748-717X nnns volume:10 year:2015 number:1 day:23 month:01 https://dx.doi.org/10.1186/s13014-015-0333-8 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2108 GBV_ILN_2111 GBV_ILN_2119 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 10 2015 1 23 01
allfieldsGer	10.1186/s13014-015-0333-8 doi (DE-627)SPR029703921 (SPR)s13014-015-0333-8-e DE-627 ger DE-627 rakwb eng Ishihara, Soichiro verfasserin aut A phase I dose escalation study of oxaliplatin plus oral S-1 and pelvic radiation in patients with locally advanced rectal cancer (SHOGUN trial) 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Ishihara et al.; licensee BioMed Central. 2015. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( Background The objective of this phase I study was to determine the maximum tolerated dose (MTD) and recommended dose (RD) of preoperative chemoradiotherapy (CRT) with S-1 plus oxaliplatin in patients with locally advanced rectal cancer. Methods Patients received radiotherapy in a total dose of 50.4 Gy in 28 fractions. Concurrent chemotherapy consisted of a fixed oral dose of S-1 (80 mg/$ m^{2} $/day) on days 1–5, 8–12, 22–27, and 29–33, plus escalated doses of oxaliplatin as an intravenous infusion on days 1, 8, 22, and 29. Oxaliplatin was initially given in a dose of 40 mg/$ m^{2} $/week to three patients. The dose was then increased in a stepwise fashion to 50 mg/$ m^{2} $/week and the highest dose level of 60 mg/$ m^{2} $/week until the MTD was attained. Results Thirteen patients were enrolled, and 12 received CRT. Dose-limiting toxicity (DLT) occurred in two of six patients (persistent grade 2 neutropenia, delaying oxaliplatin treatment by more than 3 days) at dose level 3; there were no grade 3 or 4 adverse events defined as DLT. The RD was 60 mg/$ m^{2} $/week of oxaliplatin on days 1, 8, 22, and 29. Twelve patients underwent histologically confirmed R0 resections, and two out of six patients (33%) given dose level 3 had pathological complete responses. Conclusions The RD for further studies is 80 mg/$ m^{2} $ of S-1 5 days per week plus 60 mg/$ m^{2} $ of oxaliplatin on days 1, 8, 22, and 29 and concurrent radiotherapy. Although our results are preliminary, this new regimen for neoadjuvant chemoradiotherapy is considered safe and active. Trial registration This trial was registered with Clinicaltrials.gov (identifier: NCT01227239). Rectal cancer (dpeaa)DE-He213 Chemoradiotherapy (dpeaa)DE-He213 Phase I study (dpeaa)DE-He213 Oxaliplatin (dpeaa)DE-He213 S-1 (dpeaa)DE-He213 Matsusaka, Satoshi aut Kondo, Keisaku aut Horie, Hisanaga aut Uehara, Keisuke aut Oguchi, Masahiko aut Murofushi, Keiko aut Ueno, Masashi aut Mizunuma, Nobuyuki aut Shinbo, Taijyu aut Kato, Daiki aut Okuda, Junji aut Hashiguchi, Yojiro aut Nakazawa, Masanori aut Sunami, Eiji aut Kawai, Kazushige aut Yamashita, Hideomi aut Okada, Tohru aut Ishikawa, Yuichi aut Nakajima, Toshifusa aut Watanabe, Toshiaki aut Enthalten in Radiation oncology London : BioMed Central, 2006 10(2015), 1 vom: 23. Jan. (DE-627)508725739 (DE-600)2224965-5 1748-717X nnns volume:10 year:2015 number:1 day:23 month:01 https://dx.doi.org/10.1186/s13014-015-0333-8 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2108 GBV_ILN_2111 GBV_ILN_2119 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 10 2015 1 23 01
allfieldsSound	10.1186/s13014-015-0333-8 doi (DE-627)SPR029703921 (SPR)s13014-015-0333-8-e DE-627 ger DE-627 rakwb eng Ishihara, Soichiro verfasserin aut A phase I dose escalation study of oxaliplatin plus oral S-1 and pelvic radiation in patients with locally advanced rectal cancer (SHOGUN trial) 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Ishihara et al.; licensee BioMed Central. 2015. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( Background The objective of this phase I study was to determine the maximum tolerated dose (MTD) and recommended dose (RD) of preoperative chemoradiotherapy (CRT) with S-1 plus oxaliplatin in patients with locally advanced rectal cancer. Methods Patients received radiotherapy in a total dose of 50.4 Gy in 28 fractions. Concurrent chemotherapy consisted of a fixed oral dose of S-1 (80 mg/$ m^{2} $/day) on days 1–5, 8–12, 22–27, and 29–33, plus escalated doses of oxaliplatin as an intravenous infusion on days 1, 8, 22, and 29. Oxaliplatin was initially given in a dose of 40 mg/$ m^{2} $/week to three patients. The dose was then increased in a stepwise fashion to 50 mg/$ m^{2} $/week and the highest dose level of 60 mg/$ m^{2} $/week until the MTD was attained. Results Thirteen patients were enrolled, and 12 received CRT. Dose-limiting toxicity (DLT) occurred in two of six patients (persistent grade 2 neutropenia, delaying oxaliplatin treatment by more than 3 days) at dose level 3; there were no grade 3 or 4 adverse events defined as DLT. The RD was 60 mg/$ m^{2} $/week of oxaliplatin on days 1, 8, 22, and 29. Twelve patients underwent histologically confirmed R0 resections, and two out of six patients (33%) given dose level 3 had pathological complete responses. Conclusions The RD for further studies is 80 mg/$ m^{2} $ of S-1 5 days per week plus 60 mg/$ m^{2} $ of oxaliplatin on days 1, 8, 22, and 29 and concurrent radiotherapy. Although our results are preliminary, this new regimen for neoadjuvant chemoradiotherapy is considered safe and active. Trial registration This trial was registered with Clinicaltrials.gov (identifier: NCT01227239). Rectal cancer (dpeaa)DE-He213 Chemoradiotherapy (dpeaa)DE-He213 Phase I study (dpeaa)DE-He213 Oxaliplatin (dpeaa)DE-He213 S-1 (dpeaa)DE-He213 Matsusaka, Satoshi aut Kondo, Keisaku aut Horie, Hisanaga aut Uehara, Keisuke aut Oguchi, Masahiko aut Murofushi, Keiko aut Ueno, Masashi aut Mizunuma, Nobuyuki aut Shinbo, Taijyu aut Kato, Daiki aut Okuda, Junji aut Hashiguchi, Yojiro aut Nakazawa, Masanori aut Sunami, Eiji aut Kawai, Kazushige aut Yamashita, Hideomi aut Okada, Tohru aut Ishikawa, Yuichi aut Nakajima, Toshifusa aut Watanabe, Toshiaki aut Enthalten in Radiation oncology London : BioMed Central, 2006 10(2015), 1 vom: 23. Jan. (DE-627)508725739 (DE-600)2224965-5 1748-717X nnns volume:10 year:2015 number:1 day:23 month:01 https://dx.doi.org/10.1186/s13014-015-0333-8 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2108 GBV_ILN_2111 GBV_ILN_2119 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 10 2015 1 23 01
language	English
source	Enthalten in Radiation oncology 10(2015), 1 vom: 23. Jan. volume:10 year:2015 number:1 day:23 month:01
sourceStr	Enthalten in Radiation oncology 10(2015), 1 vom: 23. Jan. volume:10 year:2015 number:1 day:23 month:01
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Rectal cancer Chemoradiotherapy Phase I study Oxaliplatin S-1
isfreeaccess_bool	false
container_title	Radiation oncology
authorswithroles_txt_mv	Ishihara, Soichiro @@aut@@ Matsusaka, Satoshi @@aut@@ Kondo, Keisaku @@aut@@ Horie, Hisanaga @@aut@@ Uehara, Keisuke @@aut@@ Oguchi, Masahiko @@aut@@ Murofushi, Keiko @@aut@@ Ueno, Masashi @@aut@@ Mizunuma, Nobuyuki @@aut@@ Shinbo, Taijyu @@aut@@ Kato, Daiki @@aut@@ Okuda, Junji @@aut@@ Hashiguchi, Yojiro @@aut@@ Nakazawa, Masanori @@aut@@ Sunami, Eiji @@aut@@ Kawai, Kazushige @@aut@@ Yamashita, Hideomi @@aut@@ Okada, Tohru @@aut@@ Ishikawa, Yuichi @@aut@@ Nakajima, Toshifusa @@aut@@ Watanabe, Toshiaki @@aut@@
publishDateDaySort_date	2015-01-23T00:00:00Z
hierarchy_top_id	508725739
id	SPR029703921
language_de	englisch
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author	Ishihara, Soichiro
spellingShingle	Ishihara, Soichiro misc Rectal cancer misc Chemoradiotherapy misc Phase I study misc Oxaliplatin misc S-1 A phase I dose escalation study of oxaliplatin plus oral S-1 and pelvic radiation in patients with locally advanced rectal cancer (SHOGUN trial)
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topic_title	A phase I dose escalation study of oxaliplatin plus oral S-1 and pelvic radiation in patients with locally advanced rectal cancer (SHOGUN trial) Rectal cancer (dpeaa)DE-He213 Chemoradiotherapy (dpeaa)DE-He213 Phase I study (dpeaa)DE-He213 Oxaliplatin (dpeaa)DE-He213 S-1 (dpeaa)DE-He213
topic	misc Rectal cancer misc Chemoradiotherapy misc Phase I study misc Oxaliplatin misc S-1
topic_unstemmed	misc Rectal cancer misc Chemoradiotherapy misc Phase I study misc Oxaliplatin misc S-1
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title	A phase I dose escalation study of oxaliplatin plus oral S-1 and pelvic radiation in patients with locally advanced rectal cancer (SHOGUN trial)
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title_full	A phase I dose escalation study of oxaliplatin plus oral S-1 and pelvic radiation in patients with locally advanced rectal cancer (SHOGUN trial)
author_sort	Ishihara, Soichiro
journal	Radiation oncology
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author_browse	Ishihara, Soichiro Matsusaka, Satoshi Kondo, Keisaku Horie, Hisanaga Uehara, Keisuke Oguchi, Masahiko Murofushi, Keiko Ueno, Masashi Mizunuma, Nobuyuki Shinbo, Taijyu Kato, Daiki Okuda, Junji Hashiguchi, Yojiro Nakazawa, Masanori Sunami, Eiji Kawai, Kazushige Yamashita, Hideomi Okada, Tohru Ishikawa, Yuichi Nakajima, Toshifusa Watanabe, Toshiaki
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author-letter	Ishihara, Soichiro
doi_str_mv	10.1186/s13014-015-0333-8
title_sort	phase i dose escalation study of oxaliplatin plus oral s-1 and pelvic radiation in patients with locally advanced rectal cancer (shogun trial)
title_auth	A phase I dose escalation study of oxaliplatin plus oral S-1 and pelvic radiation in patients with locally advanced rectal cancer (SHOGUN trial)
abstract	Background The objective of this phase I study was to determine the maximum tolerated dose (MTD) and recommended dose (RD) of preoperative chemoradiotherapy (CRT) with S-1 plus oxaliplatin in patients with locally advanced rectal cancer. Methods Patients received radiotherapy in a total dose of 50.4 Gy in 28 fractions. Concurrent chemotherapy consisted of a fixed oral dose of S-1 (80 mg/$ m^{2} $/day) on days 1–5, 8–12, 22–27, and 29–33, plus escalated doses of oxaliplatin as an intravenous infusion on days 1, 8, 22, and 29. Oxaliplatin was initially given in a dose of 40 mg/$ m^{2} $/week to three patients. The dose was then increased in a stepwise fashion to 50 mg/$ m^{2} $/week and the highest dose level of 60 mg/$ m^{2} $/week until the MTD was attained. Results Thirteen patients were enrolled, and 12 received CRT. Dose-limiting toxicity (DLT) occurred in two of six patients (persistent grade 2 neutropenia, delaying oxaliplatin treatment by more than 3 days) at dose level 3; there were no grade 3 or 4 adverse events defined as DLT. The RD was 60 mg/$ m^{2} $/week of oxaliplatin on days 1, 8, 22, and 29. Twelve patients underwent histologically confirmed R0 resections, and two out of six patients (33%) given dose level 3 had pathological complete responses. Conclusions The RD for further studies is 80 mg/$ m^{2} $ of S-1 5 days per week plus 60 mg/$ m^{2} $ of oxaliplatin on days 1, 8, 22, and 29 and concurrent radiotherapy. Although our results are preliminary, this new regimen for neoadjuvant chemoradiotherapy is considered safe and active. Trial registration This trial was registered with Clinicaltrials.gov (identifier: NCT01227239). © Ishihara et al.; licensee BioMed Central. 2015. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (
abstractGer	Background The objective of this phase I study was to determine the maximum tolerated dose (MTD) and recommended dose (RD) of preoperative chemoradiotherapy (CRT) with S-1 plus oxaliplatin in patients with locally advanced rectal cancer. Methods Patients received radiotherapy in a total dose of 50.4 Gy in 28 fractions. Concurrent chemotherapy consisted of a fixed oral dose of S-1 (80 mg/$ m^{2} $/day) on days 1–5, 8–12, 22–27, and 29–33, plus escalated doses of oxaliplatin as an intravenous infusion on days 1, 8, 22, and 29. Oxaliplatin was initially given in a dose of 40 mg/$ m^{2} $/week to three patients. The dose was then increased in a stepwise fashion to 50 mg/$ m^{2} $/week and the highest dose level of 60 mg/$ m^{2} $/week until the MTD was attained. Results Thirteen patients were enrolled, and 12 received CRT. Dose-limiting toxicity (DLT) occurred in two of six patients (persistent grade 2 neutropenia, delaying oxaliplatin treatment by more than 3 days) at dose level 3; there were no grade 3 or 4 adverse events defined as DLT. The RD was 60 mg/$ m^{2} $/week of oxaliplatin on days 1, 8, 22, and 29. Twelve patients underwent histologically confirmed R0 resections, and two out of six patients (33%) given dose level 3 had pathological complete responses. Conclusions The RD for further studies is 80 mg/$ m^{2} $ of S-1 5 days per week plus 60 mg/$ m^{2} $ of oxaliplatin on days 1, 8, 22, and 29 and concurrent radiotherapy. Although our results are preliminary, this new regimen for neoadjuvant chemoradiotherapy is considered safe and active. Trial registration This trial was registered with Clinicaltrials.gov (identifier: NCT01227239). © Ishihara et al.; licensee BioMed Central. 2015. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (
abstract_unstemmed	Background The objective of this phase I study was to determine the maximum tolerated dose (MTD) and recommended dose (RD) of preoperative chemoradiotherapy (CRT) with S-1 plus oxaliplatin in patients with locally advanced rectal cancer. Methods Patients received radiotherapy in a total dose of 50.4 Gy in 28 fractions. Concurrent chemotherapy consisted of a fixed oral dose of S-1 (80 mg/$ m^{2} $/day) on days 1–5, 8–12, 22–27, and 29–33, plus escalated doses of oxaliplatin as an intravenous infusion on days 1, 8, 22, and 29. Oxaliplatin was initially given in a dose of 40 mg/$ m^{2} $/week to three patients. The dose was then increased in a stepwise fashion to 50 mg/$ m^{2} $/week and the highest dose level of 60 mg/$ m^{2} $/week until the MTD was attained. Results Thirteen patients were enrolled, and 12 received CRT. Dose-limiting toxicity (DLT) occurred in two of six patients (persistent grade 2 neutropenia, delaying oxaliplatin treatment by more than 3 days) at dose level 3; there were no grade 3 or 4 adverse events defined as DLT. The RD was 60 mg/$ m^{2} $/week of oxaliplatin on days 1, 8, 22, and 29. Twelve patients underwent histologically confirmed R0 resections, and two out of six patients (33%) given dose level 3 had pathological complete responses. Conclusions The RD for further studies is 80 mg/$ m^{2} $ of S-1 5 days per week plus 60 mg/$ m^{2} $ of oxaliplatin on days 1, 8, 22, and 29 and concurrent radiotherapy. Although our results are preliminary, this new regimen for neoadjuvant chemoradiotherapy is considered safe and active. Trial registration This trial was registered with Clinicaltrials.gov (identifier: NCT01227239). © Ishihara et al.; licensee BioMed Central. 2015. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (
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title_short	A phase I dose escalation study of oxaliplatin plus oral S-1 and pelvic radiation in patients with locally advanced rectal cancer (SHOGUN trial)
url	https://dx.doi.org/10.1186/s13014-015-0333-8
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A phase I dose escalation study of oxaliplatin plus oral S-1 and pelvic radiation in patients with locally advanced rectal cancer (SHOGUN trial)

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