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

The result's identifiers

  • Result code in 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>

  • Alternative codes found

    RIV/00216208:11110/23:10458149

  • Result on the web

    <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>

Alternative languages

  • Result language

    angličtina

  • Original language name

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

  • Original language description

    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.

  • Czech name

  • Czech description

Classification

  • Type

    J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database

  • CEP classification

  • OECD FORD branch

    30214 - Obstetrics and gynaecology

Result continuities

  • Project

  • Continuities

    V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Others

  • Publication year

    2023

  • Confidentiality

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

Data specific for result type

  • Name of the periodical

    International Journal of Gynecological Cancer

  • ISSN

    1048-891X

  • e-ISSN

    1525-1438

  • Volume of the periodical

    33

  • Issue of the periodical within the volume

    2

  • Country of publishing house

    US - UNITED STATES

  • Number of pages

    6

  • Pages from-to

    293-298

  • UT code for WoS article

    000940912900001

  • EID of the result in the Scopus database

    2-s2.0-85147536193