[en] [en] 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 OBJECTIVES: 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 ENDPOINTS: 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.
Disciplines :
Reproductive medicine (gynecology, andrology, obstetrics)
Author, co-author :
Martinez, Alejandra ; Surgical Oncology Department, Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse Oncopole, Toulouse, France martinez.alejandra@iuct-oncopole.fr ; Centre de Recherches en Cancérologie de Toulouse, INSERM UMR 1037, Toulouse, France
Lecuru, Fabrice; Breast, Gynecology and Reconstructive Surgery Unit, Institute Curie, Paris, France
Bizzarri, Nicolò ; Fondazione Policlinico Universitario A. Gemelli, IRCCS, UOC Ginecologia Oncologica, Dipartimento per la salute della Donna e del Bambino e della Salute Pubblica, Rome, Italy
Chargari, Cyrus; Radiotherapy Department, Hôpital Pitié-Salpêtrière AP-HP, Paris, France
Ducassou, Anne; Radiotherapy Department, Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse Oncopole, France, Toulouse, France
Fagotti, Anna ; Fondazione Policlinico Universitario A. Gemelli, IRCCS, UOC Ginecologia Oncologica, Dipartimento per la salute della Donna e del Bambino e della Salute Pubblica, Rome, Italy
Fanfani, Francesco ; Fondazione Policlinico Universitario A. Gemelli, IRCCS, UOC Ginecologia Oncologica, Dipartimento per la salute della Donna e del Bambino e della Salute Pubblica, Rome, Italy
Scambia, Giovanni ; Fondazione Policlinico Universitario A. Gemelli, IRCCS, UOC Ginecologia Oncologica, Dipartimento per la salute della Donna e del Bambino e della Salute Pubblica, Rome, Italy
Cibula, David; 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
Díaz-Feijoo, Berta ; Institute Clinic of Gynecology, Obstetrics and Neonatology, Hospital Clinic de Barcelona, Institutd'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Universitat de Barcelona, Barcelona, Spain
Gil Moreno, Antonio; Gynecologic Oncology, Department of Obstetrics and Gynecology, Vall d'Hebron University Hospital, Barcelona, Spain
Angeles, Martina Aida ; Gynecologic Oncology, Department of Obstetrics and Gynecology, Vall d'Hebron University Hospital, Barcelona, Spain
Muallem, Mustafa Zelal; Department of Gynecology with Center for Oncological Surgery, Charité-Universitätsmedizin Berlin, Berlin, Germany
Kohler, Christhardt; Department of Special Operative and Oncologic Gynecology, Asklepios-Clinic Hamburg-Altona, Asklepios Hospital Group, Hamburg, Germany
Luyckx, Mathieu; Department of Gynecology-Andrology, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium
Kridelka, Frédéric ; Université de Liège - ULiège > Département des sciences cliniques > Gynécologie-Obstétrique
Rychlik, Agnieszka ; Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw, Warsaw, Poland
Gerestein, K G; Department of Obstetrics and Gynaecology, University Medical Centre Utrecht, Utrecht, The Netherlands
Heinzelmann, Viola; Obstetric and Gynaecology, University of Basel Faculty of Medicine, Zurich, Switzerland
Ramirez, Pedro T ; Department of Gynecologic Oncology and Reproductive Medicine, MD Anderson Cancer Center, Houston, Texas, USA
Frumovitz, Michael ; Department of Gynecologic Oncology and Reproductive Medicine, MD Anderson Cancer Center, Houston, Texas, USA
Ferron, Gwenael ; Surgical Oncology Department, Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse Oncopole, Toulouse, France
Betrian, Sarah; Medical Oncology Department, Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse Oncopole, Toulouse, France
Filleron, Thomas; Biostatistics & Health Data Science Unit, Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse Oncopole, Toulouse, France
Fotopoulou, Christina ; Gynaecologic Oncology, Imperial College London Faculty of Medicine, London, London, UK
Querleu, Denis ; Fondazione Policlinico Universitario A. Gemelli, IRCCS, UOC Ginecologia Oncologica, Dipartimento per la salute della Donna e del Bambino e della Salute Pubblica, Rome, Italy
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