PARa-aOrtic LymphAdenectomy in Locally Advanced Cervical Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Pacjentki w wieku 18 lat lub starsze.
- •Nowo zdiagnozowany rak szyjki macicy potwierdzony badaniem histologicznym.
- •Rak szyjki macicy w stadium IIIC1 (według klasyfikacji FIGO 2018) z nacieczonymi węzłami w miednicy, ale bez widocznych nacieków w węzłach przyaortalnych (w pobliżu aorty) w badaniu PET/CT.
- •Pacjentki, które mogą otrzymać radioterapię miednicy i chemioterapię opartą na cisplatynie.
- •Ogólny stan zdrowia pacjentki dobry (zdolna do samodzielnego funkcjonowania).
- •Przewidywany czas życia dłuższy niż 12 miesięcy.
- •Pacjentka jest w stanie stosować skuteczne metody antykoncepcji lub jest po menopauzie.
- •Pacjentka wyraża zgodę na udział w badaniu i zobowiązuje się do przestrzegania jego zasad.
✗ Disqualifies
- •Pacjentki, które wcześniej poddano leczeniu raka szyjki macicy.
- •Pacjentki, u których wykryto przerzuty do innych narządów.
- •Pacjentki, które nie mogą otrzymać radioterapii lub chemioterapii z powodu innych schorzeń.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 7, 2026
- Sex
- Female only
Therapies / drugs in trial
Locations (37)
UH Ostrava - FNO
Ostrava, Czechia
UH Plzeň
Pilsen, Czechia
General UH in Prague - VFN
Prague, Czechia
Institut de Cancérologie de l'Ouest
Angers, France
Institut Bergonié
Bordeaux, France
CHU Brest
Brest, France
Centre François Baclesse
Caen, France
Centre Hospitalier Intercommunal de Créteil
Créteil, France
Centre Georges François Leclerc
Dijon, France
Centre Oscar Lambret
Lille, France
CHRU Lille
Lille, France
CHU Limoges
Limoges, France
Centre Léon Bérard
Lyon, France
Institut Paoli Calmettes
Marseille, France
ICM Val d'Aurelle
Montpellier, France
CHU Nîmes
Nîmes, France
Hôpital Cochin
Paris, France
Hôpital Européen Georges Pompidou
Paris, France
Hôpital Lariboisière Saint Louis
Paris, France
Hôpital Pitié-Salpêtrière
Paris, France
Institut Curie
Paris, France
Hôpital Lyon Sud
Pierre-Bénite, France
Institut Godinot
Reims, France
Centre Henri Becquerel
Rouen, France
Institut Curie Site - Saint Cloud
Saint-Cloud, France
Institut de Cancérologie de l'Ouest
Saint-Herblain, France
Centre Hospitalier Universitaire La Reunion
Saint-Pierre, France
CHRU Strasbourg - ICANS
Strasbourg, France
Institut Universitaire du Cancer Toulouse - Oncopole
Toulouse, France
Chru Tours
Tours, France
Institut Gustave Roussy
Villejuif, France
Policlinico Universitario Agostino Gemelli
Roma, Italy
H.U. Vall d'Hebron
Barcelona, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain
H. Josep Trueta
Girona, Spain
H. Clínico San Carlos / Madrid
Madrid, Spain
H.U. La Paz / Madrid
Madrid, Spain
Trial contact
Jan KUMMEL, MD
Jiří PRESL
David CIBULA
Noémie BODY
Guillaume BABIN
Pierre-François DUPRE
Léopold GAICHIES, MD
Jennifer UZAN
Hélène COSTAZ
Anne-Sophie NAVARRO
Yohan KERBAGE
Tristan GAUTHIER
Eric LAMBAUDIE
Pierre-Emmanuel COLOMBO
Catherine FERRER
Bruno BORGHESE
Anne-Sophie BATS
Cyrille HUCHON
Catherine UZAN
Enora LAAS
Witold GERTYCH
Judicaël HOTTON, MD
Enora LAAS-FARON, MD
Cécile LOAEC
Phuong Lien TRAN, MD
Chérif AKLADIOS
Alejandra MARTINEZ
Lobna OULDAMER
Sébastien GOUY
Nicolo BIZZARRI
Martina ANGELES FITE, MD
Berta DIAZ-FEIJOO
Laura CARDENAS, MD
Gloria MARQUINA
Ignacio ZARPADIEL
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/8/2026.
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