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Studies

Interventional Recruiting Phase 3

NCT05581121 on ClinicalTrials.gov

PARa-aOrtic LymphAdenectomy in Locally Advanced Cervical Cancer

  • Sponsor: Oncopole Claudius Regaud
  • Collaborators: ARCAGY/ GINECO GROUP, European Network of Gynaecological Oncological Trial Groups (ENGOT), Gynecologic Cancer Intergroup (GCIG), Grupo Español de Investigación en Cáncer de Ovario, Multicenter Italian Trials in Ovarian cancer and gynecologic malignancies, Belgian Gynaecological Oncology Group, Swiss GO Trial Group, Institute of Cancer Research, United Kingdom, The Central and Eastern European Gynecologic Oncology Group, Hellenic Cooperative Oncology Group
  • Enrollment: 510 (Estimated)
  • Study start: 2023-12-20 (Actual)
  • Primary completion: 2033-12-20 (Estimated)
  • Study completion: 2033-12-20 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: None
  • PrimaryPurpose: Treatment

Brief Summary

This is an international, multicenter and randomized open-label phase III study designed to demonstrate, in patients with stage IIIC1 cervical cancer, whether para-aortic lymphadenectomy followed by tailored chemoradiation is associated with increased disease-free survival compared to patients staged with FDG-PET/CT only followed by chemoradiation.

The planned sample size is 510; including 200 patients in France.

In this trial, patients will be assigned in one of the two following treatments arms:

* Arm A (control arm): Standard chemo-radiotherapy and brachytherapy according to EMBRACE II and ESGO/ESTRO recommendations.
* Arm B (experimental arm): Pretherapeutic para-aortic lymphadenectomy followed by tailored chemo-radiotherapy and brachytherapy.

Considering the changing standard treatment landscape of locally advanced cervical cancer, both arms (control arm and experimental arm) may also be treated according to the INTERLACE and KEYNOTE-A18 studies, if applicable, at the discretion of the attending physician.

Each patient will be followed up for 5 years.

A cost-utility study will be performed in patients included in France. Other countries could be involved in this specific study. It will assess the incremental cost-utility ratio (cost per QALY gained) of para-aortic lymphadenectomy followed by tailored chemo-radiation in patients with positive PALN compared to patients staged with PET/CT only followed by chemo-radiation.

This study also has ancillary objectives:

* Biologic: To study T cell exhaustion, immune changes during chemoradiation, HPV ctDNA dynamic evolution, and the par-aortic lymph node as a premetastatic niche.
* Radiomics: To study the contribution of radiomics and FDG-PET/CT metabolic parameters to predict para-aortic lymph node involvement and clinical outcome.
* Senti-PAROLA: To evaluate the accuracy (Sensitivity, specificity, positive and negative predictive value) of the para-aortic sentinel lymph node (SPA) for PALN staging, and to evaluate the prognostic value of low volume metastasis of SPA.

Conditions

  • Cervical Carcinoma
  • Adenocarcinoma
  • Adenosquamous Carcinoma

Intervention / Treatment

  • Other: Standard treatment: Control arm
  • Procedure: Experimental arm

Primary Outcome Measures

  • Disease Free Survival (DFS) (5 years for each patient)
    DFS is defined as the time from randomization until first relapse (local, regional, or distant), or death from any cause. Patients still alive at the time of analysis without documented event (including lost to follow-up) will be censored at the last valid disease assessment.

Countries

Czechia, France, Italy, Spain

Locations and Investigators

  • UH Ostrava - FNO, Ostrava, Czechia (Recruiting)
    • Jan KUMMEL, MD
  • UH Plzeň, Pilsen, Czechia (Recruiting)
    • Jiří PRESL
  • General UH in Prague - VFN, Prague, Czechia (Recruiting)
    • David CIBULA
  • Institut de Cancérologie de l'Ouest, Angers, France (Recruiting)
    • Noémie BODY
  • Institut Bergonié, Bordeaux, France (Recruiting)
    • Guillaume BABIN
  • CHU Brest, Brest, France (Recruiting)
    • Pierre-François DUPRE
  • Centre François Baclesse, Caen, France (Not yet recruiting)
    • Léopold GAICHIES, MD
  • Centre Hospitalier Intercommunal de Créteil, Créteil, France (Recruiting)
    • Jennifer UZAN
  • Centre Georges François Leclerc, Dijon, France (Recruiting)
    • Hélène COSTAZ
  • Centre Oscar Lambret, Lille, France (Recruiting)
    • Anne-Sophie NAVARRO
  • CHRU Lille, Lille, France (Recruiting)
    • Yohan KERBAGE
  • CHU Limoges, Limoges, France (Recruiting)
    • Tristan GAUTHIER
  • Centre Léon Bérard, Lyon, France (Recruiting)
    • Léa ROSSI
  • Institut Paoli Calmettes, Marseille, France (Recruiting)
    • Eric LAMBAUDIE
  • ICM Val d'Aurelle, Montpellier, France (Recruiting)
    • Pierre-Emmanuel COLOMBO
  • CHU Nîmes, Nîmes, France (Recruiting)
    • Catherine FERRER
  • Hôpital Cochin, Paris, France (Recruiting)
    • Bruno BORGHESE
  • Hôpital Européen Georges Pompidou, Paris, France (Recruiting)
    • Anne-Sophie BATS
  • Hôpital Lariboisière Saint Louis, Paris, France (Recruiting)
    • Cyrille HUCHON
  • Hôpital Pitié-Salpêtrière, Paris, France (Recruiting)
    • Catherine UZAN
  • Institut Curie, Paris, France (Recruiting)
    • Enora LAAS
  • Hôpital Lyon Sud, Pierre-Bénite, France (Recruiting)
    • Witold GERTYCH
  • Institut Godinot, Reims, France (Recruiting)
    • Judicaël HOTTON, MD
  • Centre Henri Becquerel, Rouen, France (Withdrawn)
  • Institut Curie Site - Saint Cloud, Saint-Cloud, France (Not yet recruiting)
    • Enora LAAS-FARON, MD
  • Institut de Cancérologie de l'Ouest, Saint-Herblain, France (Recruiting)
    • Cécile LOAEC
  • Centre Hospitalier Universitaire La Reunion, Saint-Pierre, France (Recruiting)
    • Phuong Lien TRAN, MD
  • CHRU Strasbourg, Strasbourg, France (Recruiting)
    • Chérif AKLADIOS
  • Institut Universitaire du Cancer Toulouse - Oncopole, Toulouse, France (Recruiting)
    • Alejandra MARTINEZ
  • Chru Tours, Tours, France (Recruiting)
    • Lobna OULDAMER
  • Institut Gustave Roussy, Villejuif, France (Recruiting)
    • Sébastien GOUY
  • Policlinico Universitario Agostino Gemelli, Roma, Italy (Not yet recruiting)
    • Nicolo BIZZARRI
  • H.U. Vall d'Hebron, Barcelona, Spain (Recruiting)
    • Martina ANGELES FITE, MD
  • Hospital Clinic i Provincial de Barcelona, Barcelona, Spain (Recruiting)
    • Berta DIAZ-FEIJOO
  • H. Josep Trueta, Girona, Spain (Recruiting)
    • Laura CARDENAS, MD
  • H. Clínico San Carlos / Madrid, Madrid, Spain (Recruiting)
    • Gloria MARQUINA
  • H.U. La Paz / Madrid, Madrid, Spain (Recruiting)
    • Ignacio ZARPADIEL