Detail
Článek
Článek online
FT
Medvik - BMČ
  • Je něco špatně v tomto záznamu ?

PORTEC-4a: international randomized trial of molecular profile-based adjuvant treatment for women with high-intermediate risk endometrial cancer

ASVM. van den Heerik, N. Horeweg, RA. Nout, LCHW. Lutgens, EM. van der Steen-Banasik, GH. Westerveld, HA. van den Berg, A. Slot, FLA. Koppe, S. Kommoss, JWM. Mens, ME. Nowee, S. Bijmolt, D. Cibula, TC. Stam, IM. Jurgenliemk-Schulz, A. Snyers, M....

. 2020 ; 30 (12) : 2002-2007. [pub] 20201012

Jazyk angličtina Země Velká Británie

Typ dokumentu protokol klinické studie, časopisecké články, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/bmc22004774

BACKGROUND: Vaginal brachytherapy is currently recommended as adjuvant treatment in patients with high-intermediate risk endometrial cancer to maximize local control and has only mild side effects and no or limited impact on quality of life. However, there is still considerable overtreatment and also some undertreatment, which may be reduced by tailoring adjuvant treatment to the patients' risk of recurrence based on molecular tumor characteristics. PRIMARY OBJECTIVES: To compare the rates of vaginal recurrence in women with high-intermediate risk endometrial cancer, treated after surgery with molecular-integrated risk profile-based recommendations for either observation, vaginal brachytherapy or external pelvic beam radiotherapy or with standard adjuvant vaginal brachytherapy STUDY HYPOTHESIS: Adjuvant treatment based on a molecular-integrated risk profile provides similar local control and recurrence-free survival as current standard adjuvant brachytherapy in patients with high-intermediate risk endometrial cancer, while sparing many patients the morbidity of adjuvant treatment and reducing healthcare costs. TRIAL DESIGN: A multicenter, international phase III randomized trial (2:1) of molecular-integrated risk profile-based adjuvant treatment (experimental arm) or adjuvant vaginal brachytherapy (standard arm). MAJOR INCLUSION/EXCLUSION CRITERIA: Women aged 18 years and over with a histological diagnosis of high-intermediate risk endometrioid endometrial cancer after total abdominal or laparoscopic hysterectomy and bilateral salpingo-oophorectomy. High-intermediate risk factors are defined as: (i) International Federation of Gynecology and Obstetrics stage IA (with invasion) and grade 3; (ii) stage IB grade 1 or 2 with age ≥60 and/or lymph-vascular space invasion; (iii) stage IB, grade 3 without lymph-vascular space invasion; or (iv) stage II (microscopic and grade 1). ENDPOINTS: The primary endpoint is vaginal recurrence. Secondary endpoints are recurrence-free and overall survival; pelvic and distant recurrence; 5-year vaginal control (including treatment for relapse); adverse events and patient-reported symptoms and quality of life; and endometrial cancer-related healthcare costs. SAMPLE SIZE: 500 eligible and evaluable patients. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: Estimated date for completing accrual will be late 2021. Estimated date for presentation of (first) results is expected in 2023. TRIAL REGISTRATION: The trial is registered at clinicaltrials.gov (NCT03469674) and ISRCTN (11659025).

Biomedical Data Sciences Leiden University Medical Center Leiden Zuid Holland The Netherlands

Comprehensive Cancer Centre Utrecht Utrecht The Netherlands

Gynecologic Oncology Centre Department of Obstetrics and Gynaecology 1st Faculty of Medicine Charles University and General University Hospital Prague Czech Republic

Medical Statistics Leiden University Medical Center Leiden Zuid Holland The Netherlands

Obstetrics and Gynecology University Medical Centre Groningen University of Groningen Groningen Groningen The Netherlands

Pathology Leiden University Medical Center Leiden Zuid Holland The Netherlands

Radation Oncology Radiotherapy Group Arnhem Gelderland The Netherlands

Radiation Oncology Amsterdam University Medical Centers University of Amsterdam Amsterdam Noord Holland The Netherlands

Radiation Oncology Catharina Hospital Eindhoven Noord Brabant The Netherlands

Radiation Oncology Erasmus Medical Center Cancer Institute Rotterdam Zuid Holland The Netherlands

Radiation Oncology Haaglanden Medical Center Den Haag Zuid Holland The Netherlands

Radiation Oncology Institut Gustave Roussy Villejuif Île de France France

Radiation Oncology Institute Verbeeten Tilburg Noord Brabant The Netherlands

Radiation Oncology Isala Klinieken Zwolle Overijssel The Netherlands

Radiation Oncology Leiden University Medical Center Leiden Zuid Holland The Netherlands

Radiation Oncology Maastricht University Medical Centre Maastricht Limburg The Netherlands

Radiation Oncology Netherlands Cancer Institute Amsterdam Noord Holland The Netherlands

Radiation Oncology Radboudumc Nijmegen Gelderland The Netherlands

Radiation Oncology Radiotherapy Institute Friesland Leeuwarden Friesland The Netherlands

Radiation Oncology St Luke's Hospital Dublin Dublin Ireland

Radiation Oncology University Hospital Ghent Gent Oost Vlaanderen Belgium

Radiation Oncology University Medical Centre Groningen University of Groningen Groningen Groningen The Netherlands

Radiation Oncology University Medical Centre Utrecht Utrecht The Netherlands

Radiation Oncology Zuidwest Radiotherapeutic Institute Vlissingen Zeeland The Netherlands

Women's Health Rotkreuzklinikum Munchen Munchen Bayern Germany

Women's Health Universitätsklinikum Tübingen Tübingen Baden Württemberg Germany

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc22004774
003      
CZ-PrNML
005      
20220127145003.0
007      
ta
008      
220113s2020 xxk f 000 0|eng||
009      
AR
024    7_
$a 10.1136/ijgc-2020-001929 $2 doi
035    __
$a (PubMed)33046573
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a xxk
100    1_
$a van den Heerik, Anne Sophie V M $u Radiation Oncology, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands a.v.m.van_den_heerik@lumc.nl
245    10
$a PORTEC-4a: international randomized trial of molecular profile-based adjuvant treatment for women with high-intermediate risk endometrial cancer / $c ASVM. van den Heerik, N. Horeweg, RA. Nout, LCHW. Lutgens, EM. van der Steen-Banasik, GH. Westerveld, HA. van den Berg, A. Slot, FLA. Koppe, S. Kommoss, JWM. Mens, ME. Nowee, S. Bijmolt, D. Cibula, TC. Stam, IM. Jurgenliemk-Schulz, A. Snyers, M. Hamann, AG. Zwanenburg, VLMA. Coen, K. Vandecasteele, C. Gillham, C. Chargari, KW. Verhoeven-Adema, H. Putter, WB. van den Hout, BG. Wortman, HW. Nijman, T. Bosse, CL. Creutzberg
520    9_
$a BACKGROUND: Vaginal brachytherapy is currently recommended as adjuvant treatment in patients with high-intermediate risk endometrial cancer to maximize local control and has only mild side effects and no or limited impact on quality of life. However, there is still considerable overtreatment and also some undertreatment, which may be reduced by tailoring adjuvant treatment to the patients' risk of recurrence based on molecular tumor characteristics. PRIMARY OBJECTIVES: To compare the rates of vaginal recurrence in women with high-intermediate risk endometrial cancer, treated after surgery with molecular-integrated risk profile-based recommendations for either observation, vaginal brachytherapy or external pelvic beam radiotherapy or with standard adjuvant vaginal brachytherapy STUDY HYPOTHESIS: Adjuvant treatment based on a molecular-integrated risk profile provides similar local control and recurrence-free survival as current standard adjuvant brachytherapy in patients with high-intermediate risk endometrial cancer, while sparing many patients the morbidity of adjuvant treatment and reducing healthcare costs. TRIAL DESIGN: A multicenter, international phase III randomized trial (2:1) of molecular-integrated risk profile-based adjuvant treatment (experimental arm) or adjuvant vaginal brachytherapy (standard arm). MAJOR INCLUSION/EXCLUSION CRITERIA: Women aged 18 years and over with a histological diagnosis of high-intermediate risk endometrioid endometrial cancer after total abdominal or laparoscopic hysterectomy and bilateral salpingo-oophorectomy. High-intermediate risk factors are defined as: (i) International Federation of Gynecology and Obstetrics stage IA (with invasion) and grade 3; (ii) stage IB grade 1 or 2 with age ≥60 and/or lymph-vascular space invasion; (iii) stage IB, grade 3 without lymph-vascular space invasion; or (iv) stage II (microscopic and grade 1). ENDPOINTS: The primary endpoint is vaginal recurrence. Secondary endpoints are recurrence-free and overall survival; pelvic and distant recurrence; 5-year vaginal control (including treatment for relapse); adverse events and patient-reported symptoms and quality of life; and endometrial cancer-related healthcare costs. SAMPLE SIZE: 500 eligible and evaluable patients. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: Estimated date for completing accrual will be late 2021. Estimated date for presentation of (first) results is expected in 2023. TRIAL REGISTRATION: The trial is registered at clinicaltrials.gov (NCT03469674) and ISRCTN (11659025).
650    _2
$a brachyterapie $7 D001918
650    _2
$a endometroidní karcinom $x genetika $x radioterapie $x terapie $7 D018269
650    _2
$a klinické zkoušky, fáze III jako téma $7 D017326
650    _2
$a DNA vazebné proteiny $x genetika $x metabolismus $7 D004268
650    _2
$a nádory endometria $x genetika $x radioterapie $x terapie $7 D016889
650    _2
$a ženské pohlaví $7 D005260
650    _2
$a lidé $7 D006801
650    _2
$a mismatch repair endonukleáza PMS2 $x genetika $x metabolismus $7 D000070976
650    _2
$a multicentrické studie jako téma $7 D015337
650    _2
$a MutL homolog 1 $x genetika $x metabolismus $7 D000070957
650    _2
$a homolog 2 proteinu MutS $x genetika $x metabolismus $7 D051718
650    _2
$a adjuvantní radioterapie $7 D018714
650    _2
$a randomizované kontrolované studie jako téma $7 D016032
655    _2
$a protokol klinické studie $7 D000078325
655    _2
$a časopisecké články $7 D016428
655    _2
$a práce podpořená grantem $7 D013485
700    1_
$a Horeweg, Nanda $u Radiation Oncology, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands
700    1_
$a Nout, Remi A $u Radiation Oncology, Erasmus Medical Center - Cancer Institute, Rotterdam, Zuid-Holland, The Netherlands
700    1_
$a Lutgens, Ludy C H W $u Radiation Oncology, Maastricht University Medical Centre+, Maastricht, Limburg, The Netherlands
700    1_
$a van der Steen-Banasik, Elzbieta M $u Radation Oncology, Radiotherapy Group, Arnhem, Gelderland, The Netherlands
700    1_
$a Westerveld, G Henrike $u Radiation Oncology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Noord-Holland, The Netherlands
700    1_
$a van den Berg, Hetty A $u Radiation Oncology, Catharina Hospital, Eindhoven, Noord-Brabant, The Netherlands
700    1_
$a Slot, Annerie $u Radiation Oncology, Radiotherapy Institute Friesland, Leeuwarden, Friesland, The Netherlands
700    1_
$a Koppe, Friederike L A $u Radiation Oncology, Institute Verbeeten, Tilburg, Noord-Brabant, The Netherlands
700    1_
$a Kommoss, Stefan $u Women's Health, Universitätsklinikum Tübingen, Tübingen, Baden-Württemberg, Germany
700    1_
$a Mens, Jan Willem M $u Radiation Oncology, Erasmus Medical Center - Cancer Institute, Rotterdam, Zuid-Holland, The Netherlands
700    1_
$a Nowee, Marlies E $u Radiation Oncology, Netherlands Cancer Institute, Amsterdam, Noord-Holland, The Netherlands
700    1_
$a Bijmolt, Stefan $u Radiation Oncology, University Medical Centre Groningen, University of Groningen, Groningen, Groningen, The Netherlands
700    1_
$a Cibula, David $u Gynecologic Oncology Centre, Department of Obstetrics and Gynaecology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic
700    1_
$a Stam, Tanja C $u Radiation Oncology, Haaglanden Medical Center, Den Haag, Zuid-Holland, The Netherlands
700    1_
$a Jurgenliemk-Schulz, Ina M $u Radiation Oncology, University Medical Centre Utrecht, Utrecht, The Netherlands
700    1_
$a Snyers, An $u Radiation Oncology, Radboudumc, Nijmegen, Gelderland, The Netherlands
700    1_
$a Hamann, Moritz $u Women's Health, Rotkreuzklinikum Munchen, Munchen, Bayern, Germany
700    1_
$a Zwanenburg, Aleida G $u Radiation Oncology, Isala Klinieken, Zwolle, Overijssel, The Netherlands
700    1_
$a Coen, Veronique L M A $u Radiation Oncology, Zuidwest Radiotherapeutic Institute, Vlissingen, Zeeland, The Netherlands
700    1_
$a Vandecasteele, Katrien $u Radiation Oncology, University Hospital Ghent, Gent, Oost-Vlaanderen, Belgium
700    1_
$a Gillham, Charles $u Radiation Oncology, St. Luke's Hospital Dublin, Dublin, Ireland
700    1_
$a Chargari, Cyrus $u Radiation Oncology, Institut Gustave-Roussy, Villejuif, Île-de-France, France
700    1_
$a Verhoeven-Adema, Karen W $u Comprehensive Cancer Centre Utrecht, Utrecht, The Netherlands
700    1_
$a Putter, Hein $u Medical Statistics, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands
700    1_
$a van den Hout, Wilbert B $u Biomedical Data Sciences, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands
700    1_
$a Wortman, Bastiaan G $u Radiation Oncology, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands
700    1_
$a Nijman, Hans W $u Obstetrics & Gynecology, University Medical Centre Groningen, University of Groningen, Groningen, Groningen, The Netherlands
700    1_
$a Bosse, Tjalling $u Pathology, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands
700    1_
$a Creutzberg, Carien L $u Radiation Oncology, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands
773    0_
$w MED00009896 $t International journal of gynecological cancer : official journal of the International Gynecological Cancer Society $x 1525-1438 $g Roč. 30, č. 12 (2020), s. 2002-2007
856    41
$u https://pubmed.ncbi.nlm.nih.gov/33046573 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y p $z 0
990    __
$a 20220113 $b ABA008
991    __
$a 20220127145000 $b ABA008
999    __
$a ok $b bmc $g 1752072 $s 1155923
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2020 $b 30 $c 12 $d 2002-2007 $e 20201012 $i 1525-1438 $m International journal of gynecological cancer $n Int J Gynecol Cancer $x MED00009896
LZP    __
$a Pubmed-20220113

Najít záznam

Citační ukazatele

Pouze přihlášení uživatelé

Možnosti archivace