Informations générales (source: ClinicalTrials.gov)
PARa-aOrtic LymphAdenectomy in Locally Advanced Cervical Cancer (PAROLA)
Interventional
Phase 3
Institut Claudius Regaud (Voir sur ClinicalTrials)
décembre 2023
décembre 2033
05 avril 2025
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.
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 10/04/2025 13:12:06 | Contacter | |||
| CLCC INSTITUT GUSTAVE ROUSSY | S�bastien GOUY | 19/06/2024 07:35:48 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Cochin | Bruno BORGHESE | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Europeen Georges Pompidou | Anne-Sophie BATS | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Georges François Leclerc - Dijon - France | Hélène COSTAZ | Contact (sur clinicalTrials) | |||
| Centre Henri Becquerel - Rouen - France | Agathe CROUZET | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Intercommunal de Créteil - Créteil - France | Jennifer UZAN | Contact (sur clinicalTrials) | |||
| Centre Léon Bérard - Lyon - France | Léa ROSSI | Contact (sur clinicalTrials) | |||
| Centre Oscar Lambret - Lille - France | Carlos MARTINEZ GOMEZ | Contact (sur clinicalTrials) | |||
| CHRU Lille - Lille - France | Yohan KERBAGE | Contact (sur clinicalTrials) | |||
| CHRU Strasbourg - ICANS - Strasbourg - France | Chérif AKLADIOS | Contact (sur clinicalTrials) | |||
| Chru Tours - Tours - France | Lobna OULDAMER | Contact (sur clinicalTrials) | |||
| CHU Brest - Brest - France | Pierre-François DUPRE | Contact (sur clinicalTrials) | |||
| CHU Limoges - Limoges - France | Tristan GAUTHIER | Contact (sur clinicalTrials) | |||
| CHU Nîmes - Nîmes - France | Catherine FERRER | Contact (sur clinicalTrials) | |||
| Hôpital Lariboisière Saint Louis - Paris - France | Cyrille HUCHON | Contact (sur clinicalTrials) | |||
| Hôpital Lyon Sud - Pierre-Bénite - France | Witold GERTYCH | Contact (sur clinicalTrials) | |||
| Hôpital Pitié-Salpêtrière - Paris - France | Catherine UZAN | Contact (sur clinicalTrials) | |||
| ICM Val d'Aurelle - Montpellier - France | Pierre-Emmanuel COLOMBO | Contact (sur clinicalTrials) | |||
| Institut Bergonié - Bordeaux - France | Guillaume BABIN | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de l'Ouest - Angers - France | Noémie BODY | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de l'Ouest - Saint-Herblain - France | Cécile LOAEC | Contact (sur clinicalTrials) | |||
| Institut Paoli Calmettes - Marseille - France | Guillaume BLACHE | Contact (sur clinicalTrials) | |||
| Institut Universitaire du Cancer Toulouse - Oncopole - 31059 - Toulouse - France | Alejandra MARTINEZ | Contact (sur clinicalTrials) | |||
Critères
Femme
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).
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).
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).