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Lymph node surgery may boost cervical cancer treatment

NCT ID NCT05581121

Disease control Sponsor: Institut Claudius Regaud Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times

Summary

This study looks at whether surgically removing para-aortic lymph nodes before standard chemoradiation can improve disease-free survival in people with stage IIIC1 cervical cancer. About 510 participants will be randomly assigned to either standard treatment or surgery plus tailored chemoradiation. The goal is to see if the extra surgery helps prevent the cancer from coming back.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 510 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Dec 2033

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 18 years at time of study entry 2. Newly diagnosed histologically proven cervical squamous carcinoma, adenocarcinoma, or adenosquamous tumor 3. FIGO stage IIIC1 (FIGO 2018) cervical cancer with FDG-PET/CT showing FDG-positive pelvic nodes and FDG-negative PALN including equivocal lymph nodes in the common iliac and para-aortic regions. The highest positive lymph node must be located inferior to the common iliac bifurcation in both sides (anatomical level 1). 4. Patients with TNM T stage I-IIIB. 5. FIGO stage IIIC1 cervical cancer by positive pelvic sentinel lymph node from surgical staging (either intraoperative assessment (frozen section) or from final histology - patients are not eligible after radical hysterectomy, and FDG-negative common iliac of para-aortic lymph node on PET/CT (performed before or after SLN procedure) 6. Patient eligible for pelvic radiotherapy and cisplatin-based chemotherapy with a curative intent as confirmed by a multidisciplinary board 7. ECOG performance status \< 2 i.e. 0 or 1 8. Life expectancy more than 12 months 9. Pretherapeutic imaging FDG-PET/CT images should be available for central review 10. Prior validation of the surgeon's participation in the study by the Quality Assurance Comity 11. Women should be post-menopaused or willing to accept the use of an effective contraceptive regimen during the treatment period. All non-menopaused women should have a negative pregnancy test within 72 hours prior to study entry. 12. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up 13. Not applicable since protocol revision V4. Patient participating to other clinical trials including immunotherapy strategies or adjuvant chemotherapy is also eligible for the study. Adjuvant treatment must be decided prior to randomization 14. Signed informed consent 15. Patient affiliated to a Social Health Insurance in France (French patients only). Exclusion Criteria: 1. Unequivocal positive common iliac or para-aortic lymph nodes at pretherapeutic imaging FDG-PET/CT 2. Negative or equivocal pelvic lymph nodes at pretherapeutic imaging FDG-PET/CT 3. Metastatic disease confirmed by FDG-PET/CT 4. Other histologies than adenocarcinoma, squamous cell carcinoma and adenosquamous carcinoma 5. Contraindication for cisplatin-based chemotherapy 6. Women who received any prior treatment for cervical cancer 7. Prior surgery for the cervical cancer, except for cone procedure and pelvic lymph node staging 8. Previous pelvic radiotherapy 9. History of another primary malignancy except for: Malignancy treated with curative intent and with no known active disease after 5 years, adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, adequately treated carcinoma in situ (any location) without evidence of disease. 10. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure 11. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).

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Conditions

The condition(s) this trial relates to.

adenocarcinoma adenosquamous carcinoma cervical adenocarcinoma cervical adenosquamous carcinoma cervical cancer cervical carcinoma cervical squamous cell carcinoma Uterine Cervical Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adenocarcinoma Adenosquamous carcinoma Cervical carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    36 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHRU Lille

    RECRUITING

    Lille, France

  • CHRU Strasbourg - ICANS

    NOT_YET_RECRUITING

    Strasbourg, France

  • CHU Brest

    RECRUITING

    Brest, France

  • CHU Limoges

    RECRUITING

    Limoges, France

  • CHU Nîmes

    RECRUITING

    Nîmes, France

  • Centre François Baclesse

    NOT_YET_RECRUITING

    Caen, 14076, France

  • Centre Georges François Leclerc

    RECRUITING

    Dijon, France

  • Centre Henri Becquerel

    WITHDRAWN

    Rouen, France

  • Centre Hospitalier Intercommunal de Créteil

    RECRUITING

    Créteil, France

  • Centre Hospitalier Universitaire La Reunion

    RECRUITING

    Saint-Pierre, 97448, France

  • Centre Léon Bérard

    RECRUITING

    Lyon, France

  • Centre Oscar Lambret

    RECRUITING

    Lille, France

  • Chru Tours

    RECRUITING

    Tours, France

  • General UH in Prague - VFN

    RECRUITING

    Prague, 128 08, Czechia

  • H. Clínico San Carlos / Madrid

    RECRUITING

    Madrid, 28040, Spain

  • H. Josep Trueta

    RECRUITING

    Girona, 17007, Spain

  • H.U. La Paz / Madrid

    RECRUITING

    Madrid, 28046, Spain

  • H.U. Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Clinic i Provincial de Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • Hôpital Cochin

    RECRUITING

    Paris, France

  • Hôpital Européen Georges Pompidou

    RECRUITING

    Paris, France

  • Hôpital Lariboisière Saint Louis

    RECRUITING

    Paris, France

  • Hôpital Lyon Sud

    RECRUITING

    Pierre-Bénite, France

  • Hôpital Pitié-Salpêtrière

    RECRUITING

    Paris, France

  • ICM Val d'Aurelle

    RECRUITING

    Montpellier, France

  • Institut Bergonié

    RECRUITING

    Bordeaux, France

  • Institut Curie

    RECRUITING

    Paris, France

  • Institut Curie Site - Saint Cloud

    NOT_YET_RECRUITING

    Saint-Cloud, 92210, France

  • Institut Godinot

    NOT_YET_RECRUITING

    Reims, 51726, France

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, France

  • Institut Paoli Calmettes

    RECRUITING

    Marseille, France

  • Institut Universitaire du Cancer Toulouse - Oncopole

    RECRUITING

    Toulouse, 31059, France

  • Institut de Cancérologie de l'Ouest

    RECRUITING

    Angers, France

  • Institut de Cancérologie de l'Ouest

    RECRUITING

    Saint-Herblain, France

  • Policlinico Universitario Agostino Gemelli

    NOT_YET_RECRUITING

    Roma, 00168, Italy

  • UH Ostrava - FNO

    RECRUITING

    Ostrava, 708 52, Czechia

  • UH Plzeň

    RECRUITING

    Pilsen, 326 00, Czechia

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