Hypofractionated versus standard chemoradiotherapy in the definitive treatment of uterine cervix cancer: interim results of a randomized controlled clinical trial

Purpose Concurrent chemoradiation has been the mainstay of treatment for cervix cancer. We aimed to evaluate the non-inferiority of hypofractionated chemoradiation. Methods This study was designed as a phase 2, 1:1 randomized, investigator-blinded, controlled, non-inferiority trial and we report the...
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Autor*in:	Maddah Safaei, Afsane [verfasserIn] Esmati, Ebrahim Gomar, Marzieh Akhavan, Setareh Sheikh Hasani, Shahrzad Malekzadeh Moghani, Mona Zamani, Narges Moshtaghi, Maryam Malek, Mahrooz Jafari, Fatemeh Sharifian, Azadeh Kolahdouzan, Kasra

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2024

Schlagwörter:	Cervix cancer Chemoradiotherapy Brachytherapy Hypofractionation

Anmerkung:	© The Author(s) 2024

Übergeordnetes Werk:	Enthalten in: Journal of cancer research and clinical oncology - Berlin : Springer, 1904, 150(2024), 1 vom: Jan.
Übergeordnetes Werk:	volume:150 ; year:2024 ; number:1 ; month:01

Links:	Volltext

DOI / URN:	10.1007/s00432-023-05563-8

Katalog-ID:	SPR054459613

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allfields	10.1007/s00432-023-05563-8 doi (DE-627)SPR054459613 (SPR)s00432-023-05563-8-e DE-627 ger DE-627 rakwb eng Maddah Safaei, Afsane verfasserin aut Hypofractionated versus standard chemoradiotherapy in the definitive treatment of uterine cervix cancer: interim results of a randomized controlled clinical trial 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2024 Purpose Concurrent chemoradiation has been the mainstay of treatment for cervix cancer. We aimed to evaluate the non-inferiority of hypofractionated chemoradiation. Methods This study was designed as a phase 2, 1:1 randomized, investigator-blinded, controlled, non-inferiority trial and we report the interim results after 50% accrual. Cervical cancer patients with FIGO stages IIA–IIIC were recruited from April 2021 to September 2022. The intervention consisted of 40 Gy of 3D-conformal radiation therapy (RT) in 15 fractions over 3 weeks. In the control group, patients received standard chemoradiation of 45 Gy in 25 fractions over 5 weeks. Both groups received concurrent weekly cisplatin (40 mg/$ m^{2} $). Intravaginal brachytherapy of 28 Gy in 4 weekly fractions was delivered starting 1 week after the end of chemoradiation. The primary outcome was complete clinical response(CCR) at 3 months. Secondary outcomes included acute gastrointestinal (GI), genitourinary(GU), skin, and hematologic toxicities. A p value less than 0.05 was considered significant for analyses. Results 59 patients were randomized; 30 in the control group and 29 in the intervention group. 20/30 (66.7%) of the patients in the control group and 19/29 (65.5%) in the intervention group achieved a CCR (absolute difference of 0.011, 95% CI − 0.23 to 0.25, p value: 0.13). There was a significantly higher rate of acute grade ≥ 3 GI toxicity in the intervention group (27.6%) compared with the control group (6.7%) (p value 0.032). Conclusions Despite an absolute difference of 1.1% in the 3-month CCR, our interim analysis failed to show the non-inferiority of the hypofractionated chemoradiation. Due to the higher GI toxicities, we will continue this trial using intensity-modulated radiation therapy. Registration number and date ClinicalTrials.gov: NCT04831437, 2021.4.1. Cervix cancer (dpeaa)DE-He213 Chemoradiotherapy (dpeaa)DE-He213 Brachytherapy (dpeaa)DE-He213 Hypofractionation (dpeaa)DE-He213 Esmati, Ebrahim aut Gomar, Marzieh aut Akhavan, Setareh aut Sheikh Hasani, Shahrzad aut Malekzadeh Moghani, Mona aut Zamani, Narges aut Moshtaghi, Maryam aut Malek, Mahrooz aut Jafari, Fatemeh aut Sharifian, Azadeh aut Kolahdouzan, Kasra aut Enthalten in Journal of cancer research and clinical oncology Berlin : Springer, 1904 150(2024), 1 vom: Jan. (DE-627)253769515 (DE-600)1459285-X 1432-1335 nnns volume:150 year:2024 number:1 month:01 https://dx.doi.org/10.1007/s00432-023-05563-8 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 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_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_165 GBV_ILN_170 GBV_ILN_187 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_267 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_711 GBV_ILN_2005 GBV_ILN_2014 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4277 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 150 2024 1 01
spelling	10.1007/s00432-023-05563-8 doi (DE-627)SPR054459613 (SPR)s00432-023-05563-8-e DE-627 ger DE-627 rakwb eng Maddah Safaei, Afsane verfasserin aut Hypofractionated versus standard chemoradiotherapy in the definitive treatment of uterine cervix cancer: interim results of a randomized controlled clinical trial 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2024 Purpose Concurrent chemoradiation has been the mainstay of treatment for cervix cancer. We aimed to evaluate the non-inferiority of hypofractionated chemoradiation. Methods This study was designed as a phase 2, 1:1 randomized, investigator-blinded, controlled, non-inferiority trial and we report the interim results after 50% accrual. Cervical cancer patients with FIGO stages IIA–IIIC were recruited from April 2021 to September 2022. The intervention consisted of 40 Gy of 3D-conformal radiation therapy (RT) in 15 fractions over 3 weeks. In the control group, patients received standard chemoradiation of 45 Gy in 25 fractions over 5 weeks. Both groups received concurrent weekly cisplatin (40 mg/$ m^{2} $). Intravaginal brachytherapy of 28 Gy in 4 weekly fractions was delivered starting 1 week after the end of chemoradiation. The primary outcome was complete clinical response(CCR) at 3 months. Secondary outcomes included acute gastrointestinal (GI), genitourinary(GU), skin, and hematologic toxicities. A p value less than 0.05 was considered significant for analyses. Results 59 patients were randomized; 30 in the control group and 29 in the intervention group. 20/30 (66.7%) of the patients in the control group and 19/29 (65.5%) in the intervention group achieved a CCR (absolute difference of 0.011, 95% CI − 0.23 to 0.25, p value: 0.13). There was a significantly higher rate of acute grade ≥ 3 GI toxicity in the intervention group (27.6%) compared with the control group (6.7%) (p value 0.032). Conclusions Despite an absolute difference of 1.1% in the 3-month CCR, our interim analysis failed to show the non-inferiority of the hypofractionated chemoradiation. Due to the higher GI toxicities, we will continue this trial using intensity-modulated radiation therapy. Registration number and date ClinicalTrials.gov: NCT04831437, 2021.4.1. Cervix cancer (dpeaa)DE-He213 Chemoradiotherapy (dpeaa)DE-He213 Brachytherapy (dpeaa)DE-He213 Hypofractionation (dpeaa)DE-He213 Esmati, Ebrahim aut Gomar, Marzieh aut Akhavan, Setareh aut Sheikh Hasani, Shahrzad aut Malekzadeh Moghani, Mona aut Zamani, Narges aut Moshtaghi, Maryam aut Malek, Mahrooz aut Jafari, Fatemeh aut Sharifian, Azadeh aut Kolahdouzan, Kasra aut Enthalten in Journal of cancer research and clinical oncology Berlin : Springer, 1904 150(2024), 1 vom: Jan. (DE-627)253769515 (DE-600)1459285-X 1432-1335 nnns volume:150 year:2024 number:1 month:01 https://dx.doi.org/10.1007/s00432-023-05563-8 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 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_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_165 GBV_ILN_170 GBV_ILN_187 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_267 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_711 GBV_ILN_2005 GBV_ILN_2014 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4277 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 150 2024 1 01
allfields_unstemmed	10.1007/s00432-023-05563-8 doi (DE-627)SPR054459613 (SPR)s00432-023-05563-8-e DE-627 ger DE-627 rakwb eng Maddah Safaei, Afsane verfasserin aut Hypofractionated versus standard chemoradiotherapy in the definitive treatment of uterine cervix cancer: interim results of a randomized controlled clinical trial 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2024 Purpose Concurrent chemoradiation has been the mainstay of treatment for cervix cancer. We aimed to evaluate the non-inferiority of hypofractionated chemoradiation. Methods This study was designed as a phase 2, 1:1 randomized, investigator-blinded, controlled, non-inferiority trial and we report the interim results after 50% accrual. Cervical cancer patients with FIGO stages IIA–IIIC were recruited from April 2021 to September 2022. The intervention consisted of 40 Gy of 3D-conformal radiation therapy (RT) in 15 fractions over 3 weeks. In the control group, patients received standard chemoradiation of 45 Gy in 25 fractions over 5 weeks. Both groups received concurrent weekly cisplatin (40 mg/$ m^{2} $). Intravaginal brachytherapy of 28 Gy in 4 weekly fractions was delivered starting 1 week after the end of chemoradiation. The primary outcome was complete clinical response(CCR) at 3 months. Secondary outcomes included acute gastrointestinal (GI), genitourinary(GU), skin, and hematologic toxicities. A p value less than 0.05 was considered significant for analyses. Results 59 patients were randomized; 30 in the control group and 29 in the intervention group. 20/30 (66.7%) of the patients in the control group and 19/29 (65.5%) in the intervention group achieved a CCR (absolute difference of 0.011, 95% CI − 0.23 to 0.25, p value: 0.13). There was a significantly higher rate of acute grade ≥ 3 GI toxicity in the intervention group (27.6%) compared with the control group (6.7%) (p value 0.032). Conclusions Despite an absolute difference of 1.1% in the 3-month CCR, our interim analysis failed to show the non-inferiority of the hypofractionated chemoradiation. Due to the higher GI toxicities, we will continue this trial using intensity-modulated radiation therapy. Registration number and date ClinicalTrials.gov: NCT04831437, 2021.4.1. Cervix cancer (dpeaa)DE-He213 Chemoradiotherapy (dpeaa)DE-He213 Brachytherapy (dpeaa)DE-He213 Hypofractionation (dpeaa)DE-He213 Esmati, Ebrahim aut Gomar, Marzieh aut Akhavan, Setareh aut Sheikh Hasani, Shahrzad aut Malekzadeh Moghani, Mona aut Zamani, Narges aut Moshtaghi, Maryam aut Malek, Mahrooz aut Jafari, Fatemeh aut Sharifian, Azadeh aut Kolahdouzan, Kasra aut Enthalten in Journal of cancer research and clinical oncology Berlin : Springer, 1904 150(2024), 1 vom: Jan. (DE-627)253769515 (DE-600)1459285-X 1432-1335 nnns volume:150 year:2024 number:1 month:01 https://dx.doi.org/10.1007/s00432-023-05563-8 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 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_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_165 GBV_ILN_170 GBV_ILN_187 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_267 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_711 GBV_ILN_2005 GBV_ILN_2014 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4277 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 150 2024 1 01
allfieldsGer	10.1007/s00432-023-05563-8 doi (DE-627)SPR054459613 (SPR)s00432-023-05563-8-e DE-627 ger DE-627 rakwb eng Maddah Safaei, Afsane verfasserin aut Hypofractionated versus standard chemoradiotherapy in the definitive treatment of uterine cervix cancer: interim results of a randomized controlled clinical trial 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2024 Purpose Concurrent chemoradiation has been the mainstay of treatment for cervix cancer. We aimed to evaluate the non-inferiority of hypofractionated chemoradiation. Methods This study was designed as a phase 2, 1:1 randomized, investigator-blinded, controlled, non-inferiority trial and we report the interim results after 50% accrual. Cervical cancer patients with FIGO stages IIA–IIIC were recruited from April 2021 to September 2022. The intervention consisted of 40 Gy of 3D-conformal radiation therapy (RT) in 15 fractions over 3 weeks. In the control group, patients received standard chemoradiation of 45 Gy in 25 fractions over 5 weeks. Both groups received concurrent weekly cisplatin (40 mg/$ m^{2} $). Intravaginal brachytherapy of 28 Gy in 4 weekly fractions was delivered starting 1 week after the end of chemoradiation. The primary outcome was complete clinical response(CCR) at 3 months. Secondary outcomes included acute gastrointestinal (GI), genitourinary(GU), skin, and hematologic toxicities. A p value less than 0.05 was considered significant for analyses. Results 59 patients were randomized; 30 in the control group and 29 in the intervention group. 20/30 (66.7%) of the patients in the control group and 19/29 (65.5%) in the intervention group achieved a CCR (absolute difference of 0.011, 95% CI − 0.23 to 0.25, p value: 0.13). There was a significantly higher rate of acute grade ≥ 3 GI toxicity in the intervention group (27.6%) compared with the control group (6.7%) (p value 0.032). Conclusions Despite an absolute difference of 1.1% in the 3-month CCR, our interim analysis failed to show the non-inferiority of the hypofractionated chemoradiation. Due to the higher GI toxicities, we will continue this trial using intensity-modulated radiation therapy. Registration number and date ClinicalTrials.gov: NCT04831437, 2021.4.1. Cervix cancer (dpeaa)DE-He213 Chemoradiotherapy (dpeaa)DE-He213 Brachytherapy (dpeaa)DE-He213 Hypofractionation (dpeaa)DE-He213 Esmati, Ebrahim aut Gomar, Marzieh aut Akhavan, Setareh aut Sheikh Hasani, Shahrzad aut Malekzadeh Moghani, Mona aut Zamani, Narges aut Moshtaghi, Maryam aut Malek, Mahrooz aut Jafari, Fatemeh aut Sharifian, Azadeh aut Kolahdouzan, Kasra aut Enthalten in Journal of cancer research and clinical oncology Berlin : Springer, 1904 150(2024), 1 vom: Jan. (DE-627)253769515 (DE-600)1459285-X 1432-1335 nnns volume:150 year:2024 number:1 month:01 https://dx.doi.org/10.1007/s00432-023-05563-8 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 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_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_165 GBV_ILN_170 GBV_ILN_187 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_267 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_711 GBV_ILN_2005 GBV_ILN_2014 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4277 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 150 2024 1 01
allfieldsSound	10.1007/s00432-023-05563-8 doi (DE-627)SPR054459613 (SPR)s00432-023-05563-8-e DE-627 ger DE-627 rakwb eng Maddah Safaei, Afsane verfasserin aut Hypofractionated versus standard chemoradiotherapy in the definitive treatment of uterine cervix cancer: interim results of a randomized controlled clinical trial 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2024 Purpose Concurrent chemoradiation has been the mainstay of treatment for cervix cancer. We aimed to evaluate the non-inferiority of hypofractionated chemoradiation. Methods This study was designed as a phase 2, 1:1 randomized, investigator-blinded, controlled, non-inferiority trial and we report the interim results after 50% accrual. Cervical cancer patients with FIGO stages IIA–IIIC were recruited from April 2021 to September 2022. The intervention consisted of 40 Gy of 3D-conformal radiation therapy (RT) in 15 fractions over 3 weeks. In the control group, patients received standard chemoradiation of 45 Gy in 25 fractions over 5 weeks. Both groups received concurrent weekly cisplatin (40 mg/$ m^{2} $). Intravaginal brachytherapy of 28 Gy in 4 weekly fractions was delivered starting 1 week after the end of chemoradiation. The primary outcome was complete clinical response(CCR) at 3 months. Secondary outcomes included acute gastrointestinal (GI), genitourinary(GU), skin, and hematologic toxicities. A p value less than 0.05 was considered significant for analyses. Results 59 patients were randomized; 30 in the control group and 29 in the intervention group. 20/30 (66.7%) of the patients in the control group and 19/29 (65.5%) in the intervention group achieved a CCR (absolute difference of 0.011, 95% CI − 0.23 to 0.25, p value: 0.13). There was a significantly higher rate of acute grade ≥ 3 GI toxicity in the intervention group (27.6%) compared with the control group (6.7%) (p value 0.032). Conclusions Despite an absolute difference of 1.1% in the 3-month CCR, our interim analysis failed to show the non-inferiority of the hypofractionated chemoradiation. Due to the higher GI toxicities, we will continue this trial using intensity-modulated radiation therapy. Registration number and date ClinicalTrials.gov: NCT04831437, 2021.4.1. Cervix cancer (dpeaa)DE-He213 Chemoradiotherapy (dpeaa)DE-He213 Brachytherapy (dpeaa)DE-He213 Hypofractionation (dpeaa)DE-He213 Esmati, Ebrahim aut Gomar, Marzieh aut Akhavan, Setareh aut Sheikh Hasani, Shahrzad aut Malekzadeh Moghani, Mona aut Zamani, Narges aut Moshtaghi, Maryam aut Malek, Mahrooz aut Jafari, Fatemeh aut Sharifian, Azadeh aut Kolahdouzan, Kasra aut Enthalten in Journal of cancer research and clinical oncology Berlin : Springer, 1904 150(2024), 1 vom: Jan. (DE-627)253769515 (DE-600)1459285-X 1432-1335 nnns volume:150 year:2024 number:1 month:01 https://dx.doi.org/10.1007/s00432-023-05563-8 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 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_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_165 GBV_ILN_170 GBV_ILN_187 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_267 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_711 GBV_ILN_2005 GBV_ILN_2014 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4277 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 150 2024 1 01
language	English
source	Enthalten in Journal of cancer research and clinical oncology 150(2024), 1 vom: Jan. volume:150 year:2024 number:1 month:01
sourceStr	Enthalten in Journal of cancer research and clinical oncology 150(2024), 1 vom: Jan. volume:150 year:2024 number:1 month:01
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Cervix cancer Chemoradiotherapy Brachytherapy Hypofractionation
isfreeaccess_bool	true
container_title	Journal of cancer research and clinical oncology
authorswithroles_txt_mv	Maddah Safaei, Afsane @@aut@@ Esmati, Ebrahim @@aut@@ Gomar, Marzieh @@aut@@ Akhavan, Setareh @@aut@@ Sheikh Hasani, Shahrzad @@aut@@ Malekzadeh Moghani, Mona @@aut@@ Zamani, Narges @@aut@@ Moshtaghi, Maryam @@aut@@ Malek, Mahrooz @@aut@@ Jafari, Fatemeh @@aut@@ Sharifian, Azadeh @@aut@@ Kolahdouzan, Kasra @@aut@@
publishDateDaySort_date	2024-01-01T00:00:00Z
hierarchy_top_id	253769515
id	SPR054459613
language_de	englisch
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We aimed to evaluate the non-inferiority of hypofractionated chemoradiation. Methods This study was designed as a phase 2, 1:1 randomized, investigator-blinded, controlled, non-inferiority trial and we report the interim results after 50% accrual. Cervical cancer patients with FIGO stages IIA–IIIC were recruited from April 2021 to September 2022. The intervention consisted of 40 Gy of 3D-conformal radiation therapy (RT) in 15 fractions over 3 weeks. In the control group, patients received standard chemoradiation of 45 Gy in 25 fractions over 5 weeks. Both groups received concurrent weekly cisplatin (40 mg/$ m^{2} $). Intravaginal brachytherapy of 28 Gy in 4 weekly fractions was delivered starting 1 week after the end of chemoradiation. The primary outcome was complete clinical response(CCR) at 3 months. Secondary outcomes included acute gastrointestinal (GI), genitourinary(GU), skin, and hematologic toxicities. A p value less than 0.05 was considered significant for analyses. Results 59 patients were randomized; 30 in the control group and 29 in the intervention group. 20/30 (66.7%) of the patients in the control group and 19/29 (65.5%) in the intervention group achieved a CCR (absolute difference of 0.011, 95% CI − 0.23 to 0.25, p value: 0.13). There was a significantly higher rate of acute grade ≥ 3 GI toxicity in the intervention group (27.6%) compared with the control group (6.7%) (p value 0.032). Conclusions Despite an absolute difference of 1.1% in the 3-month CCR, our interim analysis failed to show the non-inferiority of the hypofractionated chemoradiation. Due to the higher GI toxicities, we will continue this trial using intensity-modulated radiation therapy. 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author	Maddah Safaei, Afsane
spellingShingle	Maddah Safaei, Afsane misc Cervix cancer misc Chemoradiotherapy misc Brachytherapy misc Hypofractionation Hypofractionated versus standard chemoradiotherapy in the definitive treatment of uterine cervix cancer: interim results of a randomized controlled clinical trial
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topic_title	Hypofractionated versus standard chemoradiotherapy in the definitive treatment of uterine cervix cancer: interim results of a randomized controlled clinical trial Cervix cancer (dpeaa)DE-He213 Chemoradiotherapy (dpeaa)DE-He213 Brachytherapy (dpeaa)DE-He213 Hypofractionation (dpeaa)DE-He213
topic	misc Cervix cancer misc Chemoradiotherapy misc Brachytherapy misc Hypofractionation
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title	Hypofractionated versus standard chemoradiotherapy in the definitive treatment of uterine cervix cancer: interim results of a randomized controlled clinical trial
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title_full	Hypofractionated versus standard chemoradiotherapy in the definitive treatment of uterine cervix cancer: interim results of a randomized controlled clinical trial
author_sort	Maddah Safaei, Afsane
journal	Journal of cancer research and clinical oncology
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author_browse	Maddah Safaei, Afsane Esmati, Ebrahim Gomar, Marzieh Akhavan, Setareh Sheikh Hasani, Shahrzad Malekzadeh Moghani, Mona Zamani, Narges Moshtaghi, Maryam Malek, Mahrooz Jafari, Fatemeh Sharifian, Azadeh Kolahdouzan, Kasra
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doi_str_mv	10.1007/s00432-023-05563-8
title_sort	hypofractionated versus standard chemoradiotherapy in the definitive treatment of uterine cervix cancer: interim results of a randomized controlled clinical trial
title_auth	Hypofractionated versus standard chemoradiotherapy in the definitive treatment of uterine cervix cancer: interim results of a randomized controlled clinical trial
abstract	Purpose Concurrent chemoradiation has been the mainstay of treatment for cervix cancer. We aimed to evaluate the non-inferiority of hypofractionated chemoradiation. Methods This study was designed as a phase 2, 1:1 randomized, investigator-blinded, controlled, non-inferiority trial and we report the interim results after 50% accrual. Cervical cancer patients with FIGO stages IIA–IIIC were recruited from April 2021 to September 2022. The intervention consisted of 40 Gy of 3D-conformal radiation therapy (RT) in 15 fractions over 3 weeks. In the control group, patients received standard chemoradiation of 45 Gy in 25 fractions over 5 weeks. Both groups received concurrent weekly cisplatin (40 mg/$ m^{2} $). Intravaginal brachytherapy of 28 Gy in 4 weekly fractions was delivered starting 1 week after the end of chemoradiation. The primary outcome was complete clinical response(CCR) at 3 months. Secondary outcomes included acute gastrointestinal (GI), genitourinary(GU), skin, and hematologic toxicities. A p value less than 0.05 was considered significant for analyses. Results 59 patients were randomized; 30 in the control group and 29 in the intervention group. 20/30 (66.7%) of the patients in the control group and 19/29 (65.5%) in the intervention group achieved a CCR (absolute difference of 0.011, 95% CI − 0.23 to 0.25, p value: 0.13). There was a significantly higher rate of acute grade ≥ 3 GI toxicity in the intervention group (27.6%) compared with the control group (6.7%) (p value 0.032). Conclusions Despite an absolute difference of 1.1% in the 3-month CCR, our interim analysis failed to show the non-inferiority of the hypofractionated chemoradiation. Due to the higher GI toxicities, we will continue this trial using intensity-modulated radiation therapy. Registration number and date ClinicalTrials.gov: NCT04831437, 2021.4.1. © The Author(s) 2024
abstractGer	Purpose Concurrent chemoradiation has been the mainstay of treatment for cervix cancer. We aimed to evaluate the non-inferiority of hypofractionated chemoradiation. Methods This study was designed as a phase 2, 1:1 randomized, investigator-blinded, controlled, non-inferiority trial and we report the interim results after 50% accrual. Cervical cancer patients with FIGO stages IIA–IIIC were recruited from April 2021 to September 2022. The intervention consisted of 40 Gy of 3D-conformal radiation therapy (RT) in 15 fractions over 3 weeks. In the control group, patients received standard chemoradiation of 45 Gy in 25 fractions over 5 weeks. Both groups received concurrent weekly cisplatin (40 mg/$ m^{2} $). Intravaginal brachytherapy of 28 Gy in 4 weekly fractions was delivered starting 1 week after the end of chemoradiation. The primary outcome was complete clinical response(CCR) at 3 months. Secondary outcomes included acute gastrointestinal (GI), genitourinary(GU), skin, and hematologic toxicities. A p value less than 0.05 was considered significant for analyses. Results 59 patients were randomized; 30 in the control group and 29 in the intervention group. 20/30 (66.7%) of the patients in the control group and 19/29 (65.5%) in the intervention group achieved a CCR (absolute difference of 0.011, 95% CI − 0.23 to 0.25, p value: 0.13). There was a significantly higher rate of acute grade ≥ 3 GI toxicity in the intervention group (27.6%) compared with the control group (6.7%) (p value 0.032). Conclusions Despite an absolute difference of 1.1% in the 3-month CCR, our interim analysis failed to show the non-inferiority of the hypofractionated chemoradiation. Due to the higher GI toxicities, we will continue this trial using intensity-modulated radiation therapy. Registration number and date ClinicalTrials.gov: NCT04831437, 2021.4.1. © The Author(s) 2024
abstract_unstemmed	Purpose Concurrent chemoradiation has been the mainstay of treatment for cervix cancer. We aimed to evaluate the non-inferiority of hypofractionated chemoradiation. Methods This study was designed as a phase 2, 1:1 randomized, investigator-blinded, controlled, non-inferiority trial and we report the interim results after 50% accrual. Cervical cancer patients with FIGO stages IIA–IIIC were recruited from April 2021 to September 2022. The intervention consisted of 40 Gy of 3D-conformal radiation therapy (RT) in 15 fractions over 3 weeks. In the control group, patients received standard chemoradiation of 45 Gy in 25 fractions over 5 weeks. Both groups received concurrent weekly cisplatin (40 mg/$ m^{2} $). Intravaginal brachytherapy of 28 Gy in 4 weekly fractions was delivered starting 1 week after the end of chemoradiation. The primary outcome was complete clinical response(CCR) at 3 months. Secondary outcomes included acute gastrointestinal (GI), genitourinary(GU), skin, and hematologic toxicities. A p value less than 0.05 was considered significant for analyses. Results 59 patients were randomized; 30 in the control group and 29 in the intervention group. 20/30 (66.7%) of the patients in the control group and 19/29 (65.5%) in the intervention group achieved a CCR (absolute difference of 0.011, 95% CI − 0.23 to 0.25, p value: 0.13). There was a significantly higher rate of acute grade ≥ 3 GI toxicity in the intervention group (27.6%) compared with the control group (6.7%) (p value 0.032). Conclusions Despite an absolute difference of 1.1% in the 3-month CCR, our interim analysis failed to show the non-inferiority of the hypofractionated chemoradiation. Due to the higher GI toxicities, we will continue this trial using intensity-modulated radiation therapy. Registration number and date ClinicalTrials.gov: NCT04831437, 2021.4.1. © The Author(s) 2024
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title_short	Hypofractionated versus standard chemoradiotherapy in the definitive treatment of uterine cervix cancer: interim results of a randomized controlled clinical trial
url	https://dx.doi.org/10.1007/s00432-023-05563-8
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author2	Esmati, Ebrahim Gomar, Marzieh Akhavan, Setareh Sheikh Hasani, Shahrzad Malekzadeh Moghani, Mona Zamani, Narges Moshtaghi, Maryam Malek, Mahrooz Jafari, Fatemeh Sharifian, Azadeh Kolahdouzan, Kasra
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Hypofractionated versus standard chemoradiotherapy in the definitive treatment of uterine cervix cancer: interim results of a randomized controlled clinical trial

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