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Clinical trial
PARa-aOrtic LymphAdenectomy in locally advanced cervical cancer (PAROLA trial): a GINECO, ENGOT, and GCIG study
  1. Alejandra Martinez1,2,
  2. Fabrice Lecuru3,
  3. Nicolò Bizzarri4,
  4. Cyrus Chargari5,
  5. Anne Ducassou6,
  6. Anna Fagotti4,
  7. Francesco Fanfani4,
  8. Giovanni Scambia4,
  9. David Cibula7,
  10. Berta Díaz-Feijoo8,
  11. Antonio Gil Moreno9,
  12. Martina Aida Angeles9,
  13. Mustafa Zelal Muallem10,
  14. Christhardt Kohler11,
  15. Mathieu Luyckx12,
  16. Frederic Kridelka13,
  17. Agnieszka Rychlik14,
  18. KG Gerestein15,
  19. Viola Heinzelmann16,
  20. Pedro T Ramirez17,
  21. Michael Frumovitz17,
  22. Gwenael Ferron1,
  23. Sarah Betrian18,
  24. Thomas Filleron19,
  25. Christina Fotopoulou20 and
  26. Denis Querleu4
  27. the PAROLA Study group
    1. 1 Surgical Oncology Department, Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse Oncopole, Toulouse, France
    2. 2 Centre de Recherches en Cancérologie de Toulouse, INSERM UMR 1037, Toulouse, France
    3. 3 Breast, Gynecology and Reconstructive Surgery Unit, Institute Curie, Paris, France
    4. 4 Fondazione Policlinico Universitario A. Gemelli, IRCCS, UOC Ginecologia Oncologica, Dipartimento per la salute della Donna e del Bambino e della Salute Pubblica, Rome, Italy
    5. 5 Radiotherapy Department, Hôpital Pitié-Salpêtrière AP-HP, Paris, France
    6. 6 Radiotherapy Department, Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse Oncopole, France, Toulouse, France
    7. 7 Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital (Central and Eastern European Gynecologic Oncology Group CEEGOG), Prague, Czech Republic
    8. 8 Institute Clinic of Gynecology, Obstetrics and Neonatology, Hospital Clinic de Barcelona, Institutd'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Universitat de Barcelona, Barcelona, Spain
    9. 9 Gynecologic Oncology, Department of Obstetrics and Gynecology, Vall d’Hebron University Hospital, Barcelona, Spain
    10. 10 Department of Gynecology with Center for Oncological Surgery, Charité—Universitätsmedizin Berlin, Berlin, Germany
    11. 11 Department of Special Operative and Oncologic Gynecology, Asklepios-Clinic Hamburg-Altona, Asklepios Hospital Group, Hamburg, Germany
    12. 12 Department of Gynecology-Andrology, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium
    13. 13 Department of Obstetrics and Gynecology, University of Liège, Liege, Belgium
    14. 14 Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw, Warsaw, Poland
    15. 15 Department of Obstetrics and Gynaecology, University Medical Centre Utrecht, Utrecht, The Netherlands
    16. 16 Obstetric and Gynaecology, University of Basel Faculty of Medicine, Zurich, Switzerland
    17. 17 Department of Gynecologic Oncology and Reproductive Medicine, MD Anderson Cancer Center, Houston, Texas, USA
    18. 18 Medical Oncology Department, Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse Oncopole, Toulouse, France
    19. 19 Biostatistics & Health Data Science Unit, Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse Oncopole, Toulouse, France
    20. 20 Gynaecologic Oncology, Imperial College London Faculty of Medicine, London, London, UK
    1. Correspondence to Professor Alejandra Martinez, Surgical Oncology Department, Institut Claudius Regaud. Institut Universitaire du Cancer Toulouse Oncopole, France, Toulouse, France; martinez.alejandra{at}iuct-oncopole.fr

    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.

    • cervical cancer
    • lymph nodes
    • radiotherapy, intensity-modulated

    Data availability statement

    No data are available.

    https://doi.org/10.1136/ijgc-2022-004223

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      Data availability statement

      No data are available.

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      Footnotes

      • Twitter @Alejandra, @annafagottimd, @frafanfani, @Bertadiazfeijoo#, @AngelesFite, @ZMuallem, @pedroramirezMD, @frumovitz

      • Collaborators PAROLA Study Group: Stéphanie Motton, Elodie Chantalat, Yann Tanguy le Gac, Enora Laas, Fabrice Narducci, Eric Lambaudie, Sebastien Gouy, Charles André Philip, Catherine Uzan, Cyril Touboul, Cyrille Huchon, C Durdux, Frédéric Guyon, Agathe Crouzet, Hélène Costaz, Bruno Borghese, Pierre-Emmanuel Colombo, Nicolas Chopin, Cherif Akladios, Marcos Ballester, Catherine Ferrer.

      • Contributors All authors made the appropriate contributions, carefully compiling and analyzing data, reading the manuscript and giving their full approval. AM accepts full responsibility for the work and/or the conduct of the study, had access to the data, and controlled the decision to publish.

      • Funding This study was funded by French National Cancer Institute (Grant number: PHRC-22-161).

      • Competing interests None declared.

      • Provenance and peer review Not commissioned; internally peer reviewed.