PARa-aOrtic LymphAdenectomy in locally advanced cervical cancer (PAROLA trial): a GINECO, ENGOT, and GCIG study

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064165%3A_____%2F23%3A10458149" target="_blank" >RIV/00064165:_____/23:10458149 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216208:11110/23:10458149

Výsledek na webu

<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=CKeHnqsRVv" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=CKeHnqsRVv</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1136/ijgc-2022-004223" target="_blank" >10.1136/ijgc-2022-004223</a>

Jazyk výsledku

angličtina

Název v původním jazyce

PARa-aOrtic LymphAdenectomy in locally advanced cervical cancer (PAROLA trial): a GINECO, ENGOT, and GCIG study

Popis výsledku v původním jazyce

Background: Positron emission tomography/computed tomography (PET/CT) fails to detect approximately 25% of aortic lymph node metastasis in patients with PET/CT stage IIIC1 cervical cancer. Surgical staging could lead to treatment modification and to improved para- aortic and distant control.Primary Objective(s): To demonstrate if chemoradiation with tailored external beam radiation field based on surgical staging and pathologic examination of the para-aortic lymph node is associated with improved 3- year disease- free survival compared with patients staged with PET/CT staging only.Study Hypothesis: Surgical staging followed by tailored chemoradiation will improve disease- free survival while avoiding unnecessary prophylactic extended- field chemoradiation in patients with International Federation of Gynecology and Obstetrics (FIGO) stage IIIC1 cervical cancer.Trial Design: This is an international multicenter, randomized, phase III study. Eligible patients will be randomized 1:1 between PET/CT staging followed by chemoradiation (control arm), or surgical staging followed by tailored chemo-radiation (experimental arm). Randomization will be stratified by tumor stage according to TNM classification, center, and adjuvant treatment.Major Inclusion/Exclusion: Criteria Main inclusion criteria are histologically proven PET/CT FIGO stage IIIC1 cervical cancer. Main exclusion criteria include unequivocal positive common iliac or para- aortic lymph node at pre-therapeutic imaging PET/CT.Primary Endpoint(s): The primary endpoint is disease-free survival defined as the time from randomization until first relapse (local, regional, or distant), or death from any cause. Sample Size: 510 eligible patients Estimated Dates for Completing Accrual and Presenting Results: The estimated date for completing accrual will be Q2 2027. The estimated date for presenting results will be Q4 2030.

Název v anglickém jazyce

PARa-aOrtic LymphAdenectomy in locally advanced cervical cancer (PAROLA trial): a GINECO, ENGOT, and GCIG study

Popis výsledku anglicky

Background: Positron emission tomography/computed tomography (PET/CT) fails to detect approximately 25% of aortic lymph node metastasis in patients with PET/CT stage IIIC1 cervical cancer. Surgical staging could lead to treatment modification and to improved para- aortic and distant control.Primary Objective(s): To demonstrate if chemoradiation with tailored external beam radiation field based on surgical staging and pathologic examination of the para-aortic lymph node is associated with improved 3- year disease- free survival compared with patients staged with PET/CT staging only.Study Hypothesis: Surgical staging followed by tailored chemoradiation will improve disease- free survival while avoiding unnecessary prophylactic extended- field chemoradiation in patients with International Federation of Gynecology and Obstetrics (FIGO) stage IIIC1 cervical cancer.Trial Design: This is an international multicenter, randomized, phase III study. Eligible patients will be randomized 1:1 between PET/CT staging followed by chemoradiation (control arm), or surgical staging followed by tailored chemo-radiation (experimental arm). Randomization will be stratified by tumor stage according to TNM classification, center, and adjuvant treatment.Major Inclusion/Exclusion: Criteria Main inclusion criteria are histologically proven PET/CT FIGO stage IIIC1 cervical cancer. Main exclusion criteria include unequivocal positive common iliac or para- aortic lymph node at pre-therapeutic imaging PET/CT.Primary Endpoint(s): The primary endpoint is disease-free survival defined as the time from randomization until first relapse (local, regional, or distant), or death from any cause. Sample Size: 510 eligible patients Estimated Dates for Completing Accrual and Presenting Results: The estimated date for completing accrual will be Q2 2027. The estimated date for presenting results will be Q4 2030.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30214 - Obstetrics and gynaecology

Projekt

—

Návaznosti

V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Rok uplatnění

2023

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

International Journal of Gynecological Cancer

ISSN

1048-891X

e-ISSN

1525-1438

Svazek periodika

33

Číslo periodika v rámci svazku

2

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

6

Strana od-do

293-298

Kód UT WoS článku

000940912900001

EID výsledku v databázi Scopus

2-s2.0-85147536193