HIPECT4: multicentre, randomized clinical trial to evaluate safety and efficacy of Hyperthermic intra-peritoneal chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma

Background Local relapse and peritoneal carcinomatosis (PC) for pT4 colon cancer is estimated in 15,6% and 36,7% for 12 months and 36 months from surgical resection respectively, achieving a 5 years overall survival of 6%. There are promising results using prophylactic HIPEC in this group of patient...
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Autor*in:	Arjona-Sánchez, A. [verfasserIn] Barrios, P. Boldo-Roda, E. Camps, B. Carrasco-Campos, J. Concepción Martín, V. García-Fadrique, A. Gutiérrez-Calvo, A. Morales, R. Ortega-Pérez, G. Pérez-Viejo, E. Prada-Villaverde, A. Torres-Melero, J. Vicente, E. Villarejo-Campos, P. Sánchez-Hidalgo, J. M. Casado-Adam, A. García-Martin, Ruben Medina, Manuel Caro, T. Villar, C. Aranda, Enrique Cano-Osuna, M. T. Díaz-López, C. Torres-Tordera, E. Briceño-Delgado, F. J. Rufián-Peña, S.

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2018

Schlagwörter:	Colon carcinoma HIPEC Peritoneal carcinomatosis Chemoprophylaxis

Anmerkung:	© The Author(s). 2018

Übergeordnetes Werk:	Enthalten in: BMC cancer - London : BioMed Central, 2001, 18(2018), 1 vom: 13. Feb.
Übergeordnetes Werk:	volume:18 ; year:2018 ; number:1 ; day:13 ; month:02

Links:	Volltext

DOI / URN:	10.1186/s12885-018-4096-0

Katalog-ID:	SPR027695506

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520			\|a Background Local relapse and peritoneal carcinomatosis (PC) for pT4 colon cancer is estimated in 15,6% and 36,7% for 12 months and 36 months from surgical resection respectively, achieving a 5 years overall survival of 6%. There are promising results using prophylactic HIPEC in this group of patients, and it is estimated that up to 26% of all T4 colon cancer could benefit from this treatment with a minimal morbidity. Adjuvant HIPEC is effective to avoid the possibility of peritoneal seeding after surgical resection. Taking into account these results and the cumulative experience in HIPEC use, we will lead a randomized controlled trial to determine the effectiveness and safety of adjuvant treatment with HIPEC vs. standard treatment in patients with colon cancer at high risk of peritoneal recurrence (pT4). Methods/Design The aim of this study is to determine the effectiveness and safety of adjuvant HIPEC in preventing the development of PC in patients with colon cancer with a high risk of peritoneal recurrence (cT4). This study will be carried out in 15 Spanish HIPEC centres. Eligible for inclusion are patients who underwent curative resection for cT4NxM0 stage colon cancer. After resection of the primary tumour, 200 patients will be randomized to adjuvant HIPEC followed by routine adjuvant systemic chemotherapy in the experimental arm, or to systemic chemotherapy only in the control arm. Adjuvant HIPEC will be performed simultaneously after the primary resection. Mitomycin C will be used as chemotherapeutic agent, for 60 min at 42–43 °C. Primary endpoint is loco-regional control (LC) in months and the rate of loco-regional control (%LC) at 12 months and 36 months after resection. Discussion We assumed that adjuvant HIPEC will reduce the expected absolute risk of peritoneal recurrence from 36% to 18% at 36 months for T4 colon-rectal carcinoma. Trial registration NCT02614534 (clinicaltrial.gov) Nov-2015.
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650		4	\|a Peritoneal carcinomatosis \|7 (dpeaa)DE-He213
650		4	\|a Chemoprophylaxis \|7 (dpeaa)DE-He213
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700	1		\|a Camps, B. \|4 aut
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700	1		\|a Gutiérrez-Calvo, A. \|4 aut
700	1		\|a Morales, R. \|4 aut
700	1		\|a Ortega-Pérez, G. \|4 aut
700	1		\|a Pérez-Viejo, E. \|4 aut
700	1		\|a Prada-Villaverde, A. \|4 aut
700	1		\|a Torres-Melero, J. \|4 aut
700	1		\|a Vicente, E. \|4 aut
700	1		\|a Villarejo-Campos, P. \|4 aut
700	1		\|a Sánchez-Hidalgo, J. M. \|4 aut
700	1		\|a Casado-Adam, A. \|4 aut
700	1		\|a García-Martin, Ruben \|4 aut
700	1		\|a Medina, Manuel \|4 aut
700	1		\|a Caro, T. \|4 aut
700	1		\|a Villar, C. \|4 aut
700	1		\|a Aranda, Enrique \|4 aut
700	1		\|a Cano-Osuna, M. T. \|4 aut
700	1		\|a Díaz-López, C. \|4 aut
700	1		\|a Torres-Tordera, E. \|4 aut
700	1		\|a Briceño-Delgado, F. J. \|4 aut
700	1		\|a Rufián-Peña, S. \|4 aut
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allfields	10.1186/s12885-018-4096-0 doi (DE-627)SPR027695506 (SPR)s12885-018-4096-0-e DE-627 ger DE-627 rakwb eng Arjona-Sánchez, A. verfasserin aut HIPECT4: multicentre, randomized clinical trial to evaluate safety and efficacy of Hyperthermic intra-peritoneal chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2018 Background Local relapse and peritoneal carcinomatosis (PC) for pT4 colon cancer is estimated in 15,6% and 36,7% for 12 months and 36 months from surgical resection respectively, achieving a 5 years overall survival of 6%. There are promising results using prophylactic HIPEC in this group of patients, and it is estimated that up to 26% of all T4 colon cancer could benefit from this treatment with a minimal morbidity. Adjuvant HIPEC is effective to avoid the possibility of peritoneal seeding after surgical resection. Taking into account these results and the cumulative experience in HIPEC use, we will lead a randomized controlled trial to determine the effectiveness and safety of adjuvant treatment with HIPEC vs. standard treatment in patients with colon cancer at high risk of peritoneal recurrence (pT4). Methods/Design The aim of this study is to determine the effectiveness and safety of adjuvant HIPEC in preventing the development of PC in patients with colon cancer with a high risk of peritoneal recurrence (cT4). This study will be carried out in 15 Spanish HIPEC centres. Eligible for inclusion are patients who underwent curative resection for cT4NxM0 stage colon cancer. After resection of the primary tumour, 200 patients will be randomized to adjuvant HIPEC followed by routine adjuvant systemic chemotherapy in the experimental arm, or to systemic chemotherapy only in the control arm. Adjuvant HIPEC will be performed simultaneously after the primary resection. Mitomycin C will be used as chemotherapeutic agent, for 60 min at 42–43 °C. Primary endpoint is loco-regional control (LC) in months and the rate of loco-regional control (%LC) at 12 months and 36 months after resection. Discussion We assumed that adjuvant HIPEC will reduce the expected absolute risk of peritoneal recurrence from 36% to 18% at 36 months for T4 colon-rectal carcinoma. Trial registration NCT02614534 (clinicaltrial.gov) Nov-2015. Colon carcinoma (dpeaa)DE-He213 HIPEC (dpeaa)DE-He213 Peritoneal carcinomatosis (dpeaa)DE-He213 Chemoprophylaxis (dpeaa)DE-He213 Barrios, P. aut Boldo-Roda, E. aut Camps, B. aut Carrasco-Campos, J. aut Concepción Martín, V. aut García-Fadrique, A. aut Gutiérrez-Calvo, A. aut Morales, R. aut Ortega-Pérez, G. aut Pérez-Viejo, E. aut Prada-Villaverde, A. aut Torres-Melero, J. aut Vicente, E. aut Villarejo-Campos, P. aut Sánchez-Hidalgo, J. M. aut Casado-Adam, A. aut García-Martin, Ruben aut Medina, Manuel aut Caro, T. aut Villar, C. aut Aranda, Enrique aut Cano-Osuna, M. T. aut Díaz-López, C. aut Torres-Tordera, E. aut Briceño-Delgado, F. J. aut Rufián-Peña, S. aut Enthalten in BMC cancer London : BioMed Central, 2001 18(2018), 1 vom: 13. Feb. (DE-627)326643710 (DE-600)2041352-X 1471-2407 nnns volume:18 year:2018 number:1 day:13 month:02 https://dx.doi.org/10.1186/s12885-018-4096-0 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA 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_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 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 18 2018 1 13 02
spelling	10.1186/s12885-018-4096-0 doi (DE-627)SPR027695506 (SPR)s12885-018-4096-0-e DE-627 ger DE-627 rakwb eng Arjona-Sánchez, A. verfasserin aut HIPECT4: multicentre, randomized clinical trial to evaluate safety and efficacy of Hyperthermic intra-peritoneal chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2018 Background Local relapse and peritoneal carcinomatosis (PC) for pT4 colon cancer is estimated in 15,6% and 36,7% for 12 months and 36 months from surgical resection respectively, achieving a 5 years overall survival of 6%. There are promising results using prophylactic HIPEC in this group of patients, and it is estimated that up to 26% of all T4 colon cancer could benefit from this treatment with a minimal morbidity. Adjuvant HIPEC is effective to avoid the possibility of peritoneal seeding after surgical resection. Taking into account these results and the cumulative experience in HIPEC use, we will lead a randomized controlled trial to determine the effectiveness and safety of adjuvant treatment with HIPEC vs. standard treatment in patients with colon cancer at high risk of peritoneal recurrence (pT4). Methods/Design The aim of this study is to determine the effectiveness and safety of adjuvant HIPEC in preventing the development of PC in patients with colon cancer with a high risk of peritoneal recurrence (cT4). This study will be carried out in 15 Spanish HIPEC centres. Eligible for inclusion are patients who underwent curative resection for cT4NxM0 stage colon cancer. After resection of the primary tumour, 200 patients will be randomized to adjuvant HIPEC followed by routine adjuvant systemic chemotherapy in the experimental arm, or to systemic chemotherapy only in the control arm. Adjuvant HIPEC will be performed simultaneously after the primary resection. Mitomycin C will be used as chemotherapeutic agent, for 60 min at 42–43 °C. Primary endpoint is loco-regional control (LC) in months and the rate of loco-regional control (%LC) at 12 months and 36 months after resection. Discussion We assumed that adjuvant HIPEC will reduce the expected absolute risk of peritoneal recurrence from 36% to 18% at 36 months for T4 colon-rectal carcinoma. Trial registration NCT02614534 (clinicaltrial.gov) Nov-2015. Colon carcinoma (dpeaa)DE-He213 HIPEC (dpeaa)DE-He213 Peritoneal carcinomatosis (dpeaa)DE-He213 Chemoprophylaxis (dpeaa)DE-He213 Barrios, P. aut Boldo-Roda, E. aut Camps, B. aut Carrasco-Campos, J. aut Concepción Martín, V. aut García-Fadrique, A. aut Gutiérrez-Calvo, A. aut Morales, R. aut Ortega-Pérez, G. aut Pérez-Viejo, E. aut Prada-Villaverde, A. aut Torres-Melero, J. aut Vicente, E. aut Villarejo-Campos, P. aut Sánchez-Hidalgo, J. M. aut Casado-Adam, A. aut García-Martin, Ruben aut Medina, Manuel aut Caro, T. aut Villar, C. aut Aranda, Enrique aut Cano-Osuna, M. T. aut Díaz-López, C. aut Torres-Tordera, E. aut Briceño-Delgado, F. J. aut Rufián-Peña, S. aut Enthalten in BMC cancer London : BioMed Central, 2001 18(2018), 1 vom: 13. Feb. (DE-627)326643710 (DE-600)2041352-X 1471-2407 nnns volume:18 year:2018 number:1 day:13 month:02 https://dx.doi.org/10.1186/s12885-018-4096-0 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA 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_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 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 18 2018 1 13 02
allfields_unstemmed	10.1186/s12885-018-4096-0 doi (DE-627)SPR027695506 (SPR)s12885-018-4096-0-e DE-627 ger DE-627 rakwb eng Arjona-Sánchez, A. verfasserin aut HIPECT4: multicentre, randomized clinical trial to evaluate safety and efficacy of Hyperthermic intra-peritoneal chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2018 Background Local relapse and peritoneal carcinomatosis (PC) for pT4 colon cancer is estimated in 15,6% and 36,7% for 12 months and 36 months from surgical resection respectively, achieving a 5 years overall survival of 6%. There are promising results using prophylactic HIPEC in this group of patients, and it is estimated that up to 26% of all T4 colon cancer could benefit from this treatment with a minimal morbidity. Adjuvant HIPEC is effective to avoid the possibility of peritoneal seeding after surgical resection. Taking into account these results and the cumulative experience in HIPEC use, we will lead a randomized controlled trial to determine the effectiveness and safety of adjuvant treatment with HIPEC vs. standard treatment in patients with colon cancer at high risk of peritoneal recurrence (pT4). Methods/Design The aim of this study is to determine the effectiveness and safety of adjuvant HIPEC in preventing the development of PC in patients with colon cancer with a high risk of peritoneal recurrence (cT4). This study will be carried out in 15 Spanish HIPEC centres. Eligible for inclusion are patients who underwent curative resection for cT4NxM0 stage colon cancer. After resection of the primary tumour, 200 patients will be randomized to adjuvant HIPEC followed by routine adjuvant systemic chemotherapy in the experimental arm, or to systemic chemotherapy only in the control arm. Adjuvant HIPEC will be performed simultaneously after the primary resection. Mitomycin C will be used as chemotherapeutic agent, for 60 min at 42–43 °C. Primary endpoint is loco-regional control (LC) in months and the rate of loco-regional control (%LC) at 12 months and 36 months after resection. Discussion We assumed that adjuvant HIPEC will reduce the expected absolute risk of peritoneal recurrence from 36% to 18% at 36 months for T4 colon-rectal carcinoma. Trial registration NCT02614534 (clinicaltrial.gov) Nov-2015. Colon carcinoma (dpeaa)DE-He213 HIPEC (dpeaa)DE-He213 Peritoneal carcinomatosis (dpeaa)DE-He213 Chemoprophylaxis (dpeaa)DE-He213 Barrios, P. aut Boldo-Roda, E. aut Camps, B. aut Carrasco-Campos, J. aut Concepción Martín, V. aut García-Fadrique, A. aut Gutiérrez-Calvo, A. aut Morales, R. aut Ortega-Pérez, G. aut Pérez-Viejo, E. aut Prada-Villaverde, A. aut Torres-Melero, J. aut Vicente, E. aut Villarejo-Campos, P. aut Sánchez-Hidalgo, J. M. aut Casado-Adam, A. aut García-Martin, Ruben aut Medina, Manuel aut Caro, T. aut Villar, C. aut Aranda, Enrique aut Cano-Osuna, M. T. aut Díaz-López, C. aut Torres-Tordera, E. aut Briceño-Delgado, F. J. aut Rufián-Peña, S. aut Enthalten in BMC cancer London : BioMed Central, 2001 18(2018), 1 vom: 13. Feb. (DE-627)326643710 (DE-600)2041352-X 1471-2407 nnns volume:18 year:2018 number:1 day:13 month:02 https://dx.doi.org/10.1186/s12885-018-4096-0 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA 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_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 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 18 2018 1 13 02
allfieldsGer	10.1186/s12885-018-4096-0 doi (DE-627)SPR027695506 (SPR)s12885-018-4096-0-e DE-627 ger DE-627 rakwb eng Arjona-Sánchez, A. verfasserin aut HIPECT4: multicentre, randomized clinical trial to evaluate safety and efficacy of Hyperthermic intra-peritoneal chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2018 Background Local relapse and peritoneal carcinomatosis (PC) for pT4 colon cancer is estimated in 15,6% and 36,7% for 12 months and 36 months from surgical resection respectively, achieving a 5 years overall survival of 6%. There are promising results using prophylactic HIPEC in this group of patients, and it is estimated that up to 26% of all T4 colon cancer could benefit from this treatment with a minimal morbidity. Adjuvant HIPEC is effective to avoid the possibility of peritoneal seeding after surgical resection. Taking into account these results and the cumulative experience in HIPEC use, we will lead a randomized controlled trial to determine the effectiveness and safety of adjuvant treatment with HIPEC vs. standard treatment in patients with colon cancer at high risk of peritoneal recurrence (pT4). Methods/Design The aim of this study is to determine the effectiveness and safety of adjuvant HIPEC in preventing the development of PC in patients with colon cancer with a high risk of peritoneal recurrence (cT4). This study will be carried out in 15 Spanish HIPEC centres. Eligible for inclusion are patients who underwent curative resection for cT4NxM0 stage colon cancer. After resection of the primary tumour, 200 patients will be randomized to adjuvant HIPEC followed by routine adjuvant systemic chemotherapy in the experimental arm, or to systemic chemotherapy only in the control arm. Adjuvant HIPEC will be performed simultaneously after the primary resection. Mitomycin C will be used as chemotherapeutic agent, for 60 min at 42–43 °C. Primary endpoint is loco-regional control (LC) in months and the rate of loco-regional control (%LC) at 12 months and 36 months after resection. Discussion We assumed that adjuvant HIPEC will reduce the expected absolute risk of peritoneal recurrence from 36% to 18% at 36 months for T4 colon-rectal carcinoma. Trial registration NCT02614534 (clinicaltrial.gov) Nov-2015. Colon carcinoma (dpeaa)DE-He213 HIPEC (dpeaa)DE-He213 Peritoneal carcinomatosis (dpeaa)DE-He213 Chemoprophylaxis (dpeaa)DE-He213 Barrios, P. aut Boldo-Roda, E. aut Camps, B. aut Carrasco-Campos, J. aut Concepción Martín, V. aut García-Fadrique, A. aut Gutiérrez-Calvo, A. aut Morales, R. aut Ortega-Pérez, G. aut Pérez-Viejo, E. aut Prada-Villaverde, A. aut Torres-Melero, J. aut Vicente, E. aut Villarejo-Campos, P. aut Sánchez-Hidalgo, J. M. aut Casado-Adam, A. aut García-Martin, Ruben aut Medina, Manuel aut Caro, T. aut Villar, C. aut Aranda, Enrique aut Cano-Osuna, M. T. aut Díaz-López, C. aut Torres-Tordera, E. aut Briceño-Delgado, F. J. aut Rufián-Peña, S. aut Enthalten in BMC cancer London : BioMed Central, 2001 18(2018), 1 vom: 13. Feb. (DE-627)326643710 (DE-600)2041352-X 1471-2407 nnns volume:18 year:2018 number:1 day:13 month:02 https://dx.doi.org/10.1186/s12885-018-4096-0 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA 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_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 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 18 2018 1 13 02
allfieldsSound	10.1186/s12885-018-4096-0 doi (DE-627)SPR027695506 (SPR)s12885-018-4096-0-e DE-627 ger DE-627 rakwb eng Arjona-Sánchez, A. verfasserin aut HIPECT4: multicentre, randomized clinical trial to evaluate safety and efficacy of Hyperthermic intra-peritoneal chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2018 Background Local relapse and peritoneal carcinomatosis (PC) for pT4 colon cancer is estimated in 15,6% and 36,7% for 12 months and 36 months from surgical resection respectively, achieving a 5 years overall survival of 6%. There are promising results using prophylactic HIPEC in this group of patients, and it is estimated that up to 26% of all T4 colon cancer could benefit from this treatment with a minimal morbidity. Adjuvant HIPEC is effective to avoid the possibility of peritoneal seeding after surgical resection. Taking into account these results and the cumulative experience in HIPEC use, we will lead a randomized controlled trial to determine the effectiveness and safety of adjuvant treatment with HIPEC vs. standard treatment in patients with colon cancer at high risk of peritoneal recurrence (pT4). Methods/Design The aim of this study is to determine the effectiveness and safety of adjuvant HIPEC in preventing the development of PC in patients with colon cancer with a high risk of peritoneal recurrence (cT4). This study will be carried out in 15 Spanish HIPEC centres. Eligible for inclusion are patients who underwent curative resection for cT4NxM0 stage colon cancer. After resection of the primary tumour, 200 patients will be randomized to adjuvant HIPEC followed by routine adjuvant systemic chemotherapy in the experimental arm, or to systemic chemotherapy only in the control arm. Adjuvant HIPEC will be performed simultaneously after the primary resection. Mitomycin C will be used as chemotherapeutic agent, for 60 min at 42–43 °C. Primary endpoint is loco-regional control (LC) in months and the rate of loco-regional control (%LC) at 12 months and 36 months after resection. Discussion We assumed that adjuvant HIPEC will reduce the expected absolute risk of peritoneal recurrence from 36% to 18% at 36 months for T4 colon-rectal carcinoma. Trial registration NCT02614534 (clinicaltrial.gov) Nov-2015. Colon carcinoma (dpeaa)DE-He213 HIPEC (dpeaa)DE-He213 Peritoneal carcinomatosis (dpeaa)DE-He213 Chemoprophylaxis (dpeaa)DE-He213 Barrios, P. aut Boldo-Roda, E. aut Camps, B. aut Carrasco-Campos, J. aut Concepción Martín, V. aut García-Fadrique, A. aut Gutiérrez-Calvo, A. aut Morales, R. aut Ortega-Pérez, G. aut Pérez-Viejo, E. aut Prada-Villaverde, A. aut Torres-Melero, J. aut Vicente, E. aut Villarejo-Campos, P. aut Sánchez-Hidalgo, J. M. aut Casado-Adam, A. aut García-Martin, Ruben aut Medina, Manuel aut Caro, T. aut Villar, C. aut Aranda, Enrique aut Cano-Osuna, M. T. aut Díaz-López, C. aut Torres-Tordera, E. aut Briceño-Delgado, F. J. aut Rufián-Peña, S. aut Enthalten in BMC cancer London : BioMed Central, 2001 18(2018), 1 vom: 13. Feb. (DE-627)326643710 (DE-600)2041352-X 1471-2407 nnns volume:18 year:2018 number:1 day:13 month:02 https://dx.doi.org/10.1186/s12885-018-4096-0 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA 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_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 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 18 2018 1 13 02
language	English
source	Enthalten in BMC cancer 18(2018), 1 vom: 13. Feb. volume:18 year:2018 number:1 day:13 month:02
sourceStr	Enthalten in BMC cancer 18(2018), 1 vom: 13. Feb. volume:18 year:2018 number:1 day:13 month:02
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Colon carcinoma HIPEC Peritoneal carcinomatosis Chemoprophylaxis
isfreeaccess_bool	true
container_title	BMC cancer
authorswithroles_txt_mv	Arjona-Sánchez, A. @@aut@@ Barrios, P. @@aut@@ Boldo-Roda, E. @@aut@@ Camps, B. @@aut@@ Carrasco-Campos, J. @@aut@@ Concepción Martín, V. @@aut@@ García-Fadrique, A. @@aut@@ Gutiérrez-Calvo, A. @@aut@@ Morales, R. @@aut@@ Ortega-Pérez, G. @@aut@@ Pérez-Viejo, E. @@aut@@ Prada-Villaverde, A. @@aut@@ Torres-Melero, J. @@aut@@ Vicente, E. @@aut@@ Villarejo-Campos, P. @@aut@@ Sánchez-Hidalgo, J. M. @@aut@@ Casado-Adam, A. @@aut@@ García-Martin, Ruben @@aut@@ Medina, Manuel @@aut@@ Caro, T. @@aut@@ Villar, C. @@aut@@ Aranda, Enrique @@aut@@ Cano-Osuna, M. T. @@aut@@ Díaz-López, C. @@aut@@ Torres-Tordera, E. @@aut@@ Briceño-Delgado, F. J. @@aut@@ Rufián-Peña, S. @@aut@@
publishDateDaySort_date	2018-02-13T00:00:00Z
hierarchy_top_id	326643710
id	SPR027695506
language_de	englisch
fullrecord	<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">SPR027695506</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230519100513.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">201007s2018 xx \|\|\|\|\|o 00\| \|\|eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1186/s12885-018-4096-0</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)SPR027695506</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(SPR)s12885-018-4096-0-e</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Arjona-Sánchez, A.</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">HIPECT4: multicentre, randomized clinical trial to evaluate safety and efficacy of Hyperthermic intra-peritoneal chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2018</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">© The Author(s). 2018</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Background Local relapse and peritoneal carcinomatosis (PC) for pT4 colon cancer is estimated in 15,6% and 36,7% for 12 months and 36 months from surgical resection respectively, achieving a 5 years overall survival of 6%. There are promising results using prophylactic HIPEC in this group of patients, and it is estimated that up to 26% of all T4 colon cancer could benefit from this treatment with a minimal morbidity. Adjuvant HIPEC is effective to avoid the possibility of peritoneal seeding after surgical resection. Taking into account these results and the cumulative experience in HIPEC use, we will lead a randomized controlled trial to determine the effectiveness and safety of adjuvant treatment with HIPEC vs. standard treatment in patients with colon cancer at high risk of peritoneal recurrence (pT4). Methods/Design The aim of this study is to determine the effectiveness and safety of adjuvant HIPEC in preventing the development of PC in patients with colon cancer with a high risk of peritoneal recurrence (cT4). This study will be carried out in 15 Spanish HIPEC centres. Eligible for inclusion are patients who underwent curative resection for cT4NxM0 stage colon cancer. After resection of the primary tumour, 200 patients will be randomized to adjuvant HIPEC followed by routine adjuvant systemic chemotherapy in the experimental arm, or to systemic chemotherapy only in the control arm. Adjuvant HIPEC will be performed simultaneously after the primary resection. Mitomycin C will be used as chemotherapeutic agent, for 60 min at 42–43 °C. Primary endpoint is loco-regional control (LC) in months and the rate of loco-regional control (%LC) at 12 months and 36 months after resection. Discussion We assumed that adjuvant HIPEC will reduce the expected absolute risk of peritoneal recurrence from 36% to 18% at 36 months for T4 colon-rectal carcinoma. 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author	Arjona-Sánchez, A.
spellingShingle	Arjona-Sánchez, A. misc Colon carcinoma misc HIPEC misc Peritoneal carcinomatosis misc Chemoprophylaxis HIPECT4: multicentre, randomized clinical trial to evaluate safety and efficacy of Hyperthermic intra-peritoneal chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma
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topic_title	HIPECT4: multicentre, randomized clinical trial to evaluate safety and efficacy of Hyperthermic intra-peritoneal chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma Colon carcinoma (dpeaa)DE-He213 HIPEC (dpeaa)DE-He213 Peritoneal carcinomatosis (dpeaa)DE-He213 Chemoprophylaxis (dpeaa)DE-He213
topic	misc Colon carcinoma misc HIPEC misc Peritoneal carcinomatosis misc Chemoprophylaxis
topic_unstemmed	misc Colon carcinoma misc HIPEC misc Peritoneal carcinomatosis misc Chemoprophylaxis
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title	HIPECT4: multicentre, randomized clinical trial to evaluate safety and efficacy of Hyperthermic intra-peritoneal chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma
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title_full	HIPECT4: multicentre, randomized clinical trial to evaluate safety and efficacy of Hyperthermic intra-peritoneal chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma
author_sort	Arjona-Sánchez, A.
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author_browse	Arjona-Sánchez, A. Barrios, P. Boldo-Roda, E. Camps, B. Carrasco-Campos, J. Concepción Martín, V. García-Fadrique, A. Gutiérrez-Calvo, A. Morales, R. Ortega-Pérez, G. Pérez-Viejo, E. Prada-Villaverde, A. Torres-Melero, J. Vicente, E. Villarejo-Campos, P. Sánchez-Hidalgo, J. M. Casado-Adam, A. García-Martin, Ruben Medina, Manuel Caro, T. Villar, C. Aranda, Enrique Cano-Osuna, M. T. Díaz-López, C. Torres-Tordera, E. Briceño-Delgado, F. J. Rufián-Peña, S.
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title_sort	hipect4: multicentre, randomized clinical trial to evaluate safety and efficacy of hyperthermic intra-peritoneal chemotherapy (hipec) with mitomycin c used during surgery for treatment of locally advanced colorectal carcinoma
title_auth	HIPECT4: multicentre, randomized clinical trial to evaluate safety and efficacy of Hyperthermic intra-peritoneal chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma
abstract	Background Local relapse and peritoneal carcinomatosis (PC) for pT4 colon cancer is estimated in 15,6% and 36,7% for 12 months and 36 months from surgical resection respectively, achieving a 5 years overall survival of 6%. There are promising results using prophylactic HIPEC in this group of patients, and it is estimated that up to 26% of all T4 colon cancer could benefit from this treatment with a minimal morbidity. Adjuvant HIPEC is effective to avoid the possibility of peritoneal seeding after surgical resection. Taking into account these results and the cumulative experience in HIPEC use, we will lead a randomized controlled trial to determine the effectiveness and safety of adjuvant treatment with HIPEC vs. standard treatment in patients with colon cancer at high risk of peritoneal recurrence (pT4). Methods/Design The aim of this study is to determine the effectiveness and safety of adjuvant HIPEC in preventing the development of PC in patients with colon cancer with a high risk of peritoneal recurrence (cT4). This study will be carried out in 15 Spanish HIPEC centres. Eligible for inclusion are patients who underwent curative resection for cT4NxM0 stage colon cancer. After resection of the primary tumour, 200 patients will be randomized to adjuvant HIPEC followed by routine adjuvant systemic chemotherapy in the experimental arm, or to systemic chemotherapy only in the control arm. Adjuvant HIPEC will be performed simultaneously after the primary resection. Mitomycin C will be used as chemotherapeutic agent, for 60 min at 42–43 °C. Primary endpoint is loco-regional control (LC) in months and the rate of loco-regional control (%LC) at 12 months and 36 months after resection. Discussion We assumed that adjuvant HIPEC will reduce the expected absolute risk of peritoneal recurrence from 36% to 18% at 36 months for T4 colon-rectal carcinoma. Trial registration NCT02614534 (clinicaltrial.gov) Nov-2015. © The Author(s). 2018
abstractGer	Background Local relapse and peritoneal carcinomatosis (PC) for pT4 colon cancer is estimated in 15,6% and 36,7% for 12 months and 36 months from surgical resection respectively, achieving a 5 years overall survival of 6%. There are promising results using prophylactic HIPEC in this group of patients, and it is estimated that up to 26% of all T4 colon cancer could benefit from this treatment with a minimal morbidity. Adjuvant HIPEC is effective to avoid the possibility of peritoneal seeding after surgical resection. Taking into account these results and the cumulative experience in HIPEC use, we will lead a randomized controlled trial to determine the effectiveness and safety of adjuvant treatment with HIPEC vs. standard treatment in patients with colon cancer at high risk of peritoneal recurrence (pT4). Methods/Design The aim of this study is to determine the effectiveness and safety of adjuvant HIPEC in preventing the development of PC in patients with colon cancer with a high risk of peritoneal recurrence (cT4). This study will be carried out in 15 Spanish HIPEC centres. Eligible for inclusion are patients who underwent curative resection for cT4NxM0 stage colon cancer. After resection of the primary tumour, 200 patients will be randomized to adjuvant HIPEC followed by routine adjuvant systemic chemotherapy in the experimental arm, or to systemic chemotherapy only in the control arm. Adjuvant HIPEC will be performed simultaneously after the primary resection. Mitomycin C will be used as chemotherapeutic agent, for 60 min at 42–43 °C. Primary endpoint is loco-regional control (LC) in months and the rate of loco-regional control (%LC) at 12 months and 36 months after resection. Discussion We assumed that adjuvant HIPEC will reduce the expected absolute risk of peritoneal recurrence from 36% to 18% at 36 months for T4 colon-rectal carcinoma. Trial registration NCT02614534 (clinicaltrial.gov) Nov-2015. © The Author(s). 2018
abstract_unstemmed	Background Local relapse and peritoneal carcinomatosis (PC) for pT4 colon cancer is estimated in 15,6% and 36,7% for 12 months and 36 months from surgical resection respectively, achieving a 5 years overall survival of 6%. There are promising results using prophylactic HIPEC in this group of patients, and it is estimated that up to 26% of all T4 colon cancer could benefit from this treatment with a minimal morbidity. Adjuvant HIPEC is effective to avoid the possibility of peritoneal seeding after surgical resection. Taking into account these results and the cumulative experience in HIPEC use, we will lead a randomized controlled trial to determine the effectiveness and safety of adjuvant treatment with HIPEC vs. standard treatment in patients with colon cancer at high risk of peritoneal recurrence (pT4). Methods/Design The aim of this study is to determine the effectiveness and safety of adjuvant HIPEC in preventing the development of PC in patients with colon cancer with a high risk of peritoneal recurrence (cT4). This study will be carried out in 15 Spanish HIPEC centres. Eligible for inclusion are patients who underwent curative resection for cT4NxM0 stage colon cancer. After resection of the primary tumour, 200 patients will be randomized to adjuvant HIPEC followed by routine adjuvant systemic chemotherapy in the experimental arm, or to systemic chemotherapy only in the control arm. Adjuvant HIPEC will be performed simultaneously after the primary resection. Mitomycin C will be used as chemotherapeutic agent, for 60 min at 42–43 °C. Primary endpoint is loco-regional control (LC) in months and the rate of loco-regional control (%LC) at 12 months and 36 months after resection. Discussion We assumed that adjuvant HIPEC will reduce the expected absolute risk of peritoneal recurrence from 36% to 18% at 36 months for T4 colon-rectal carcinoma. Trial registration NCT02614534 (clinicaltrial.gov) Nov-2015. © The Author(s). 2018
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title_short	HIPECT4: multicentre, randomized clinical trial to evaluate safety and efficacy of Hyperthermic intra-peritoneal chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma
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author2Str	Barrios, P. Boldo-Roda, E. Camps, B. Carrasco-Campos, J. Concepción Martín, V. García-Fadrique, A. Gutiérrez-Calvo, A. Morales, R. Ortega-Pérez, G. Pérez-Viejo, E. Prada-Villaverde, A. Torres-Melero, J. Vicente, E. Villarejo-Campos, P. Sánchez-Hidalgo, J. M. Casado-Adam, A. García-Martin, Ruben Medina, Manuel Caro, T. Villar, C. Aranda, Enrique Cano-Osuna, M. T. Díaz-López, C. Torres-Tordera, E. Briceño-Delgado, F. J. Rufián-Peña, S.
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doi_str	10.1186/s12885-018-4096-0
up_date	2024-07-03T14:33:33.539Z
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There are promising results using prophylactic HIPEC in this group of patients, and it is estimated that up to 26% of all T4 colon cancer could benefit from this treatment with a minimal morbidity. Adjuvant HIPEC is effective to avoid the possibility of peritoneal seeding after surgical resection. Taking into account these results and the cumulative experience in HIPEC use, we will lead a randomized controlled trial to determine the effectiveness and safety of adjuvant treatment with HIPEC vs. standard treatment in patients with colon cancer at high risk of peritoneal recurrence (pT4). Methods/Design The aim of this study is to determine the effectiveness and safety of adjuvant HIPEC in preventing the development of PC in patients with colon cancer with a high risk of peritoneal recurrence (cT4). This study will be carried out in 15 Spanish HIPEC centres. Eligible for inclusion are patients who underwent curative resection for cT4NxM0 stage colon cancer. After resection of the primary tumour, 200 patients will be randomized to adjuvant HIPEC followed by routine adjuvant systemic chemotherapy in the experimental arm, or to systemic chemotherapy only in the control arm. Adjuvant HIPEC will be performed simultaneously after the primary resection. Mitomycin C will be used as chemotherapeutic agent, for 60 min at 42–43 °C. Primary endpoint is loco-regional control (LC) in months and the rate of loco-regional control (%LC) at 12 months and 36 months after resection. Discussion We assumed that adjuvant HIPEC will reduce the expected absolute risk of peritoneal recurrence from 36% to 18% at 36 months for T4 colon-rectal carcinoma. 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HIPECT4: multicentre, randomized clinical trial to evaluate safety and efficacy of Hyperthermic intra-peritoneal chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma

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