Standard treatment: Control arm: Standard chemo-radiotherapy and brachytherapy according to EMBRACE II and ESGO/ESTRO recommendations.
Experimental arm: Pre-therapeutic para-aortic lymphadenectomy (by minimally invasive approach) followed by tailored chemo-radiotherapy and brachytherapy. Both traditional laparoscopy or robotically assisted laparoscopy approaches are accepted in the study.
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.
| Facility | City | Region | Status |
|---|---|---|---|
| UH Ostrava - FNO | Ostrava | Czechia | Recruiting |
| UH Plzeň | Pilsen | Czechia | Recruiting |
| General UH in Prague - VFN | Prague | Czechia | Recruiting |
| Institut de Cancérologie de l'Ouest | Angers | France | Recruiting |
| Institut Bergonié | Bordeaux | France | Recruiting |
| CHU Brest | Brest | France | Recruiting |
| Centre François Baclesse | Caen | France | Not Yet Recruiting |
| Centre Hospitalier Intercommunal de Créteil | Créteil | France | Recruiting |
| Centre Georges François Leclerc | Dijon | France | Recruiting |
| Centre Oscar Lambret | Lille | France | Recruiting |
| CHRU Lille | Lille | France | Recruiting |
| CHU Limoges | Limoges | France | Recruiting |
| Centre Léon Bérard | Lyon | France | Recruiting |
| Institut Paoli Calmettes | Marseille | France | Recruiting |
| ICM Val d'Aurelle | Montpellier | France | Recruiting |
| CHU Nîmes | Nîmes | France | Recruiting |
| Hôpital Cochin | Paris | France | Recruiting |
| Hôpital Européen Georges Pompidou | Paris | France | Recruiting |
| Hôpital Lariboisière Saint Louis | Paris | France | Recruiting |
| Hôpital Pitié-Salpêtrière | Paris | France | Recruiting |
| Institut Curie | Paris | France | Recruiting |
| Hôpital Lyon Sud | Pierre-Bénite | France | Recruiting |
| Institut Godinot | Reims | France | Not Yet Recruiting |
| Centre Henri Becquerel | Rouen | France | Withdrawn |
| Institut Curie Site - Saint Cloud | Saint-Cloud | France | Not Yet Recruiting |
| Institut de Cancérologie de l'Ouest | Saint-Herblain | France | Recruiting |
| Centre Hospitalier Universitaire La Reunion | Saint-Pierre | France | Recruiting |
| CHRU Strasbourg - ICANS | Strasbourg | France | Not Yet Recruiting |
| Institut Universitaire du Cancer Toulouse - Oncopole | Toulouse | France | Recruiting |
| Chru Tours | Tours | France | Recruiting |
| Institut Gustave Roussy | Villejuif | France | Recruiting |
| Policlinico Universitario Agostino Gemelli | Roma | Italy | Not Yet Recruiting |
| H.U. Vall d'Hebron | Barcelona | Spain | Recruiting |
| Hospital Clinic i Provincial de Barcelona | Barcelona | Spain | Recruiting |
| H. Josep Trueta | Girona | Spain | Recruiting |
| H. Clínico San Carlos / Madrid | Madrid | Spain | Recruiting |
| H.U. La Paz / Madrid | Madrid | Spain | Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05581121 on ClinicalTrials.gov ↗ ← All trials in France