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

doi:10.1136/ijgc-2022-004223

Randomized Controlled Trial

. 2023 Feb 6;33(2):293-298.

doi: 10.1136/ijgc-2022-004223.

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

Alejandra Martinez^{1

2}, Fabrice Lecuru³, Nicolò Bizzarri⁴, Cyrus Chargari⁵, Anne Ducassou⁶, Anna Fagotti⁴, Francesco Fanfani⁴, Giovanni Scambia⁴, David Cibula⁷, Berta Díaz-Feijoo⁸, Antonio Gil Moreno⁹, Martina Aida Angeles⁹, Mustafa Zelal Muallem¹⁰, Christhardt Kohler¹¹, Mathieu Luyckx¹², Frederic Kridelka¹³, Agnieszka Rychlik¹⁴, K G Gerestein¹⁵, Viola Heinzelmann¹⁶, Pedro T Ramirez¹⁷, Michael Frumovitz¹⁷, Gwenael Ferron¹⁸, Sarah Betrian¹⁹, Thomas Filleron²⁰, Christina Fotopoulou²¹, Denis Querleu⁴; PAROLA Study group

Collaborators, Affiliations

Affiliations

¹ Surgical Oncology Department, Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse Oncopole, Toulouse, France martinez.alejandra@iuct-oncopole.fr.
² Centre de Recherches en Cancérologie de Toulouse, INSERM UMR 1037, Toulouse, France.
³ Breast, Gynecology and Reconstructive Surgery Unit, Institute Curie, Paris, France.
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 Radiotherapy Department, Hôpital Pitié-Salpêtrière AP-HP, Paris, France.
⁶ Radiotherapy Department, Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse Oncopole, France, Toulouse, France.
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 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 Gynecologic Oncology, Department of Obstetrics and Gynecology, Vall d'Hebron University Hospital, Barcelona, Spain.
¹⁰ Department of Gynecology with Center for Oncological Surgery, Charité-Universitätsmedizin Berlin, Berlin, Germany.
¹¹ Department of Special Operative and Oncologic Gynecology, Asklepios-Clinic Hamburg-Altona, Asklepios Hospital Group, Hamburg, Germany.
¹² Department of Gynecology-Andrology, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium.
¹³ Department of Obstetrics and Gynecology, University of Liège, Liege, Belgium.
¹⁴ Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw, Warsaw, Poland.
¹⁵ Department of Obstetrics and Gynaecology, University Medical Centre Utrecht, Utrecht, The Netherlands.
¹⁶ Obstetric and Gynaecology, University of Basel Faculty of Medicine, Zurich, Switzerland.
¹⁷ Department of Gynecologic Oncology and Reproductive Medicine, MD Anderson Cancer Center, Houston, Texas, USA.
¹⁸ Surgical Oncology Department, Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse Oncopole, Toulouse, France.
¹⁹ Medical Oncology Department, Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse Oncopole, Toulouse, France.
²⁰ Biostatistics & Health Data Science Unit, Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse Oncopole, Toulouse, France.
²¹ Gynaecologic Oncology, Imperial College London Faculty of Medicine, London, London, UK.

PMID: 36717163
DOI: 10.1136/ijgc-2022-004223

Free article

Randomized Controlled Trial

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

Alejandra Martinez et al. Int J Gynecol Cancer. 2023.

Free article

. 2023 Feb 6;33(2):293-298.

doi: 10.1136/ijgc-2022-004223.

Authors

Affiliations

¹ Surgical Oncology Department, Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse Oncopole, Toulouse, France martinez.alejandra@iuct-oncopole.fr.
² Centre de Recherches en Cancérologie de Toulouse, INSERM UMR 1037, Toulouse, France.
³ Breast, Gynecology and Reconstructive Surgery Unit, Institute Curie, Paris, France.
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 Radiotherapy Department, Hôpital Pitié-Salpêtrière AP-HP, Paris, France.
⁶ Radiotherapy Department, Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse Oncopole, France, Toulouse, France.
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 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 Gynecologic Oncology, Department of Obstetrics and Gynecology, Vall d'Hebron University Hospital, Barcelona, Spain.
¹⁰ Department of Gynecology with Center for Oncological Surgery, Charité-Universitätsmedizin Berlin, Berlin, Germany.
¹¹ Department of Special Operative and Oncologic Gynecology, Asklepios-Clinic Hamburg-Altona, Asklepios Hospital Group, Hamburg, Germany.
¹² Department of Gynecology-Andrology, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium.
¹³ Department of Obstetrics and Gynecology, University of Liège, Liege, Belgium.
¹⁴ Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw, Warsaw, Poland.
¹⁵ Department of Obstetrics and Gynaecology, University Medical Centre Utrecht, Utrecht, The Netherlands.
¹⁶ Obstetric and Gynaecology, University of Basel Faculty of Medicine, Zurich, Switzerland.
¹⁷ Department of Gynecologic Oncology and Reproductive Medicine, MD Anderson Cancer Center, Houston, Texas, USA.
¹⁸ Surgical Oncology Department, Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse Oncopole, Toulouse, France.
¹⁹ Medical Oncology Department, Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse Oncopole, Toulouse, France.
²⁰ Biostatistics & Health Data Science Unit, Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse Oncopole, Toulouse, France.
²¹ Gynaecologic Oncology, Imperial College London Faculty of Medicine, London, London, UK.

PMID: 36717163
DOI: 10.1136/ijgc-2022-004223

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 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.

Keywords: cervical cancer; lymph nodes; radiotherapy, intensity-modulated.

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Conflict of interest statement

Competing interests: None declared.

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

Collaborators

Affiliations

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

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Conflict of interest statement

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