PARa-aOrtic LymphAdenectomy in locally advanced cervical cancer (PAROLA trial): a GINECO, ENGOT, and GCIG study. Issue 2 (30th January 2023)

• Record Type: Journal Article
• Authors: Martinez, Alejandra; Lecuru, Fabrice; Bizzarri, Nicolò; Chargari, Cyrus; Ducassou, Anne; Fagotti, Anna; Fanfani, Francesco; Scambia, Giovanni; Cibula, David; Díaz-Feijoo, Berta; Gil Moreno, Antonio; Angeles, Martina Aida; Muallem, Mustafa Zelal; Kohler, Christhardt; Luyckx, Mathieu; Kridelka, Frederic; Rychlik, Agnieszka; Gerestein, KG; Heinzelmann, Viola; Ramirez, Pedro T; Frumovitz, Michael; Ferron, Gwenael; Betrian, Sarah; Filleron, Thomas; Fotopoulou, Christina; Querleu, Denis
• Other Names: author non-byline.; Motton Stéphanie author non-byline.; Chantalat Elodie author non-byline.; Gac Yann Tanguy le author non-byline.; Laas Enora author non-byline.; Narducci Fabrice author non-byline.; Lambaudie Eric author non-byline.; Gouy Sebastien author non-byline.; Philip Charles André author non-byline.; Uzan Catherine author non-byline.; Touboul Cyril author non-byline.; Huchon Cyrille author non-byline.; Durdux C author non-byline.; Guyon Frédéric author non-byline.; Crouzet Agathe author non-byline.; Costaz Hélène author non-byline.; Borghese Bruno author non-byline.; Colombo Pierre-Emmanuel author non-byline.; Chopin Nicolas author non-byline.; Akladios Cherif author non-byline.; Ballester Marcos author non-byline.; Ferrer Catherine author non-byline.
• Is Part Of: International journal of gynecological cancer. Volume 33:Issue 2(2023)
• Page Start: 293
• Page End: 298
• Publication Date: 2023-01-30
• Subjects: cervical cancer -- lymph nodes -- radiotherapy, intensity-modulated; Generative organs, Female -- Cancer -- Periodicals; 616.99465
• DOI: 10.1136/ijgc-2022-004223
• Languages: English
• ISSNs: 1048-891X

Abstract

Abstract : 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. Trial Registration Number: NCT05581121 .