RecruitingPhase 3NCT05581121

PARa-aOrtic LymphAdenectomy in Locally Advanced Cervical Cancer


Sponsor

Institut Claudius Regaud

Enrollment

510 participants

Start Date

Dec 20, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether surgically removing lymph nodes near the aorta (the large blood vessel in the abdomen) before starting radiation therapy improves outcomes for women with locally advanced cervical cancer where pelvic lymph nodes are affected but abdominal lymph nodes appear cancer-free on a PET scan. **You may be eligible if...** - You are 18 or older - You have been newly diagnosed with cervical cancer (squamous, adenocarcinoma, or adenosquamous type) - Your cancer has spread to pelvic lymph nodes but NOT to lymph nodes near the aorta (confirmed by a PET scan) - You are in an appropriate cancer stage for this type of treatment **You may NOT be eligible if...** - Your cancer has already spread to lymph nodes near the aorta - You have already had a radical hysterectomy - You are not suitable for surgery as determined by your doctor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERStandard treatment: Control arm

Standard chemo-radiotherapy and brachytherapy according to EMBRACE II and ESGO/ESTRO recommendations.

PROCEDUREExperimental 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.


Locations(34)

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

Hospital Clinic i Provincial de Barcelona

Barcelona, Spain

H. Clínico San Carlos / Madrid

Madrid, Spain

H.U. La Paz / Madrid

Madrid, Spain

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NCT05581121


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