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Cervical CarcinomaPhase 3PAROLANCT05581121

PARa-aOrtic LymphAdenectomy in Locally Advanced Cervical Cancer

A Phase 3 study testing Experimental arm in people with Cervical Carcinoma and Adenocarcinoma, run by Institut Claudius Regaud at 37 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Experimental arm
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
510 participants
Where
37 sitesin 4 countries
Study dates
20 Dec 2023to 20 Dec 2033
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years at time of study entry
  • Newly diagnosed histologically proven cervical squamous carcinoma, adenocarcinoma, or adenosquamous tumor
  • 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).
  • Patients with TNM T stage I-IIIB.
  • 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)
  • Patient eligible for pelvic radiotherapy and cisplatin-based chemotherapy with a curative intent as confirmed by a multidisciplinary board
Show all 15Show fewer
  • ECOG performance status < 2 i.e. 0 or 1
  • Life expectancy more than 12 months
  • Pretherapeutic imaging FDG-PET/CT images should be available for central review
  • Prior validation of the surgeon's participation in the study by the Quality Assurance Comity
  • 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.
  • 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
  • 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
  • Signed informed consent
  • Patient affiliated to a Social Health Insurance in France (French patients only).

Who cannot join

  • Unequivocal positive common iliac or para-aortic lymph nodes at pretherapeutic imaging FDG-PET/CT
  • Negative or equivocal pelvic lymph nodes at pretherapeutic imaging FDG-PET/CT
  • Metastatic disease confirmed by FDG-PET/CT
  • Other histologies than adenocarcinoma, squamous cell carcinoma and adenosquamous carcinoma
  • Contraindication for cisplatin-based chemotherapy
  • Women who received any prior treatment for cervical cancer
Show all 11Show fewer
  • Prior surgery for the cervical cancer, except for cone procedure and pelvic lymph node staging
  • Previous pelvic radiotherapy
  • 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.
  • 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
  • Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).

Trial locations and contacts

37 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

37 sites in 4 countries

France28 sites, 27 recruiting

  • Institut de Cancérologie de l'Ouest

    Angers

    Noémie BODY, 02 41 35 27 00, noemie.body@ico.unicancer.fr

    Recruiting

  • Institut Bergonié

    Bordeaux

    Guillaume BABIN, 05 56 33 33 33, g.babin@bordeaux.unicancer.fr

    Recruiting

  • CHU Brest

    Brest

    Pierre-François DUPRE, 02 98 22 37 59, pierre-francois.dupre@chu-brest.fr

    Recruiting

  • Centre François Baclesse

    Caen, 14076

    Léopold GAICHIES, MD, 02 31 45 50 50, l.gaichies@baclesse.unicancer.fr

    Not yet recruiting

  • Centre Hospitalier Intercommunal de Créteil

    Créteil

    Jennifer UZAN, 01 57 02 22 44, jennifer.uzan@chicreteil.fr

    Recruiting

  • Centre Georges François Leclerc

    Dijon

    Hélène COSTAZ, +33 (0) 3 80 73 75 08, hcostaz@cgfl.fr

    Recruiting

  • Centre Oscar Lambret

    Lille

    Anne-Sophie NAVARRO, +33 (0) 3.20.29.59.59, a-navarro@o-lambret.fr

    Recruiting

  • CHRU Lille

    Lille

    Yohan KERBAGE, 03 20 44 66 38, yohan.kerbage@chu-lille.fr

    Recruiting

  • CHU Limoges

    Limoges

    Tristan GAUTHIER, 05 55 05 61 64, tristan.gauthier@chu-limoges.fr

    Recruiting

  • Centre Léon Bérard

    Lyon

    Léa ROSSI, 04 78 78 27 76, lea.rossi@lyon.unicancer.fr

    Recruiting

  • Institut Paoli Calmettes

    Marseille

    Eric LAMBAUDIE, +33 (0) 4 91 22 35 32, lambaudiee@ipc.unicancer.fr

    Recruiting

  • ICM Val d'Aurelle

    Montpellier

    Pierre-Emmanuel COLOMBO, +33 (0) 4 67 61 24 01, Pierre-Emmanuel.Colombo@icm.unicancer.fr

    Recruiting

  • CHU Nîmes

    Nîmes

    Catherine FERRER, +33 (0) 4 66 68 32 16, catherine.ferrer@chu-nimes.fr

    Recruiting

  • Hôpital Cochin

    Paris

    Bruno BORGHESE, +33(0) 1 44 41 23 17, bruno.borghese@aphp.fr

    Recruiting

  • Hôpital Européen Georges Pompidou

    Paris

    Anne-Sophie BATS, 01 56 09 35 86, anne-sophie.bats@aphp.fr

    Recruiting

  • Hôpital Lariboisière Saint Louis

    Paris

    Cyrille HUCHON, +33 (0) 1 49 95 62 78, cyrille.huchon@aphp.fr

    Recruiting

  • Hôpital Pitié-Salpêtrière

    Paris

    Catherine UZAN, 01 42 17 81 14, catherine.uzan@aphp.fr

    Recruiting

  • Institut Curie

    Paris

    Enora LAAS, +33 (0) 1 44 32 46 53, enora.laas@curie.fr

    Recruiting

  • Hôpital Lyon Sud

    Pierre-Bénite

    Witold GERTYCH, 04 78 86 13 82, witold.gertych@chu-lyon.fr

    Recruiting

  • Institut Godinot

    Reims, 51726

    Judicaël HOTTON, MD, 03 26 50 44 91, judicael.hotton@reims.unicancer.fr

    Recruiting

  • Centre Henri Becquerel

    Rouen

    Withdrawn

  • Institut Curie Site - Saint Cloud

    Saint-Cloud, 92210

    Enora LAAS-FARON, MD, 01 56 24 62 36, enora.laas@curie.fr

    Not yet recruiting

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain

    Cécile LOAEC, 02 40 67 99 00, cecile.loaec@ico.unicancer.fr

    Recruiting

  • Centre Hospitalier Universitaire La Reunion

    Saint-Pierre, 97448

    Phuong Lien TRAN, MD, 02 62 35 92 01, phuong.tran@chu-reunion.fr

    Recruiting

  • CHRU Strasbourg

    Strasbourg

    Chérif AKLADIOS, 03 68 76 67 67, cherif.akladios@chru-strasbourg.fr

    Recruiting

  • Institut Universitaire du Cancer Toulouse - Oncopole

    Toulouse, 31059

    Alejandra MARTINEZ, +33 5 31 15 53 66, martinez.alejandra@iuct-oncopole.fr

    Recruiting

  • Chru Tours

    Tours

    Lobna OULDAMER, 02 47 47 47 42, l.ouldamer@chu-tours.fr

    Recruiting

  • Institut Gustave Roussy

    Villejuif

    Sébastien GOUY, 01 42 11 47 12, sebastien.gouy@gustaveroussy.fr

    Recruiting

Other trials in France

Spain5 sites, 5 recruiting

  • H.U. Vall d'Hebron

    Barcelona, 08035

    Martina ANGELES FITE, MD, (+34) 661257374, martinangeles22@hotmail.com

    Recruiting

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036

    Berta DIAZ-FEIJOO, (+34) 651074160, bdiazfe@clinic.cat

    Recruiting

  • H. Josep Trueta

    Girona, 17007

    Laura CARDENAS, MD, (+34) 618424109, lauracardenas.girona.ics@gencat.cat

    Recruiting

  • H. Clínico San Carlos / Madrid

    Madrid, 28040

    Gloria MARQUINA, (+34) 91 330 30 00, gloriamarquina@gmail.com

    Recruiting

  • H.U. La Paz / Madrid

    Madrid, 28046

    Ignacio ZARPADIEL, (+34) 667020440, ignaciozapardiel@hotmail.com

    Recruiting

Other trials in Spain

Czechia3 sites, 3 recruiting

  • UH Ostrava - FNO

    Ostrava, 708 52

    Jan KUMMEL, MD, +420597371804, jan.kummel@fno.cz

    Recruiting

  • UH Plzeň

    Pilsen, 326 00

    Jiří PRESL, 00420377617228, jiri.presl77@gmail.com

    Recruiting

  • General UH in Prague - VFN

    Prague, 128 08

    David CIBULA, 00420224967425, dc@davidcibula.cz

    Recruiting

Other trials in Czechia

Italy1 site, 1 recruiting

  • Policlinico Universitario Agostino Gemelli

    Roma, 00168

    Nicolo BIZZARRI, nicolo.bizzarri@yahoo.com

    Not yet recruiting

Other trials in Italy

About this 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.

Read more

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.
Being tested
Standard treatment: Control arm, Experimental arm
Keywords
Locally advanced cervical cancer, HPV 16+, Stage IIIC1, Radiation therapy, Cisplatin, Para-aortic lymphadenectomy, INTERLACE, KEYNOTE-A18
Medical subject headings
Uterine Cervical Neoplasms, Adenocarcinoma, Carcinoma, Adenosquamous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard treatment: Control armOther

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

  • Experimental armProcedure or surgery

    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.

Study groups in NCT05581121
Study groupRoleWhat they receive
Arm AOtherControl arm
Receives: Other: Standard treatment: Control arm
Arm BExperimentalExperimental arm
Receives: Procedure: Experimental arm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease Free Survival (DFS)

    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.

    Measured: 5 years for each patient

Secondary outcomes (8)

  1. Overall survival (OS)

    OS is defined by the delay between randomization and death from any cause. Patients still alive at the time of analysis (including lost of follow-up) will be censored at the last known alive date.

    Measured: 5 years for each patient

  2. Cancer Specific survival (CSS)

    CSS is defined by the delay between randomization and death from cancer. Patients still alive at the time of analysis (including lost of follow-up) or death from other cause will be censored at the last known alive date and date of death, respectively.

    Measured: 5 years for each patient

  3. Metastasis Free Survival (MFS)

    MFS is defined as the time from randomization until first distant relapse, or death from any cause. Patients still alive at the time of analysis (including loss of follow-up) without appearance of distant relapse will be censored at the last valid disease assessment.

    Measured: 5 years for each patient

  4. Para-aortic Free Survival (PAFS)

    PAFS is defined as the time from randomization until para-aortic recurrence, or death from any cause. Patients still alive at the time of analysis (including loss of follow-up) without appearance of para-aortic recurrence will be censored at the last valid disease assessment.

    Measured: 5 years for each patient

  5. Morbidity and adverse events assessed by the toxicity grading of the National Cancer Institute (NCI-CTCAE v 5.0).

    Measured: 5 years for each patient

  6. Quality of life will evaluated by the EORTC QLQ-C-30 questionnaire and its cervical cancer module (CXC-24) and the EQ-5D-5L questionnaire.

    The QLQ-C-30 response options are a 4-point Likert scale from "not at all" to "very much" or a seven-point Likert scale from "very poor" to "excellent."The QLQ-CX24 consists of 24 questions including symptom items and sexuality items. The scores/dimensions are: Body image, symptom experience, Sexual/Vaginal Functioning, Lymphedema, Peripheral Neuropathy, Menopausal Symptoms, Sexual Worry, Sexual Activity, sexual enjoyment.The EQ-5D-5L has a descriptive component (composed of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and a visual analogue scale (EQ-VAS). The EQ-5D-5L is translated and validated in French with a utility function calculated on the basis of revealed preferences of French population. The utility-preference approach of the EQ-5D-5L provides a scale with cardinal properties to calculate quality-adjusted life years (QALYs) that are uses in cost-utility analyses.

    Measured: 5 years for each patient

  7. Cost-utility analysis

    Cost per QALYs gained at 3 year and 5-year follow-up:

    • QALYs gained estimated as the area between the quality-adjusted survival curves of both groups.
    • Utilities are derived from the EQ-5D-5L questionnaire using French weights.

    Measured: 5 years for each patient

  8. False-negative rate of PET/CT and optional ultrasonography

    False-negative rate of PET/CT and optional ultrasonography for PALN (Para-Aortic Lymph Node) staging is defined as the ratio of the number of patients PALN+ on para-aortic lymphadenectomy (surgical staging) among the number of patients randomized in the experimental arm (in the overall population and in the subgroup of patients with equivocal lymph nodes).

    Measured: 3 months post-CRT (Chemo-radiotherapy and brachytherapy) treatment for each patient

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2022
  2. Study start20 Dec 2023
  3. Primary completion20 Dec 2033 (estimated)
  4. Study completion20 Dec 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
510 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05581121
Sponsor's protocol ID
22GENF08
Acronym
PAROLA
Status last verified
Oct 2026
First submitted
12 Oct 2022
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Martinez A, Lecuru F, Bizzarri N, Chargari C, Ducassou A, Fagotti A, Fanfani F, Scambia G, Cibula D, Diaz-Feijoo B, Gil Moreno A, Angeles MA, Muallem MZ, Kohler C, Luyckx M, Kridelka F, Rychlik A, Gerestein KG, Heinzelmann V, Ramirez PT, Frumovitz M, Ferron G, Betrian S, Filleron T, Fotopoulou C, Querleu D; PAROLA Study group. PARa-aOrtic LymphAdenectomy in locally advanced cervical cancer (PAROLA trial): a GINECO, ENGOT, and GCIG study. Int J Gynecol Cancer. 2023 Feb 6;33(2):293-298. doi: 10.1136/ijgc-2022-004223.

    PubMed 36717163

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Experimental arm in people with Cervical Carcinoma and Adenocarcinoma, run by Institut Claudius Regaud at 37 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in France, Spain, Czechia, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Free Survival (DFS) (time frame: 5 years for each patient). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05581121, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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