Trial Title:
PARa-aOrtic LymphAdenectomy in Locally Advanced Cervical Cancer
NCT ID:
NCT05581121
Condition:
Cervical Carcinoma
Adenocarcinoma
Adenosquamous Carcinoma
Conditions: Official terms:
Carcinoma
Uterine Cervical Neoplasms
Carcinoma, Adenosquamous
Conditions: Keywords:
Locally advanced cervical cancer
HPV 16+
Stage IIIC1
Radiation therapy
Cisplatin
Para-aortic lymphadenectomy
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Standard treatment: Control arm
Description:
Standard chemo-radiotherapy and brachytherapy according to EMBRACE II and ESGO/ESTRO
recommendations.
Arm group label:
Arm A
Intervention type:
Procedure
Intervention name:
Experimental arm
Description:
Pre-therapeutic para-aortic lymphadenectomy followed by tailored chemo-radiotherapy and
brachytherapy.
Arm group label:
Arm B
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.
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.
Criteria for eligibility:
Criteria:
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. 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).
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut Bergonié
Address:
City:
Bordeaux
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Guillaume BABIN
Phone:
05 56 33 33 33
Email:
g.babin@bordeaux.unicancer.fr
Facility:
Name:
CHU Brest
Address:
City:
Brest
Country:
France
Status:
Recruiting
Contact:
Last name:
Pierre-François DUPRE
Phone:
02 98 22 37 59
Email:
pierre-francois.dupre@chu-brest.fr
Facility:
Name:
Centre Hospitalier Intercommunal de Créteil
Address:
City:
Créteil
Country:
France
Status:
Recruiting
Contact:
Last name:
Jennifer UZAN
Phone:
01 57 02 22 44
Email:
jennifer.uzan@chicreteil.fr
Facility:
Name:
Centre Georges François Leclerc
Address:
City:
Dijon
Country:
France
Status:
Recruiting
Contact:
Last name:
Hélène COSTAZ
Phone:
+33 (0) 3 80 73 75 08
Email:
hcostaz@cgfl.fr
Facility:
Name:
Centre Oscar Lambret
Address:
City:
Lille
Country:
France
Status:
Recruiting
Contact:
Last name:
Carlos MARTINEZ GOMEZ
Phone:
+33 (0) 3.20.29.59.59
Email:
c-martinezgomez@o-lambret.fr
Facility:
Name:
CHRU Lille
Address:
City:
Lille
Country:
France
Status:
Recruiting
Contact:
Last name:
Yohan KERBAGE
Phone:
03 20 44 66 38
Email:
yohan.kerbage@chu-lille.fr
Facility:
Name:
CHU Limoges
Address:
City:
Limoges
Country:
France
Status:
Recruiting
Contact:
Last name:
Tristan GAUTHIER
Phone:
05 55 05 61 64
Email:
tristan.gauthier@chu-limoges.fr
Facility:
Name:
Institut Paoli Calmettes
Address:
City:
Marseille
Country:
France
Status:
Recruiting
Contact:
Last name:
Guillaume BLACHE
Phone:
+33 (0) 4 91 22 33 66
Email:
blacheg@ipc.unicancer.fr
Facility:
Name:
ICM Val d'Aurelle
Address:
City:
Montpellier
Country:
France
Status:
Recruiting
Contact:
Last name:
Pierre-Emmanuel COLOMBO
Phone:
+33 (0) 4 67 61 24 01
Email:
Pierre-Emmanuel.Colombo@icm.unicancer.fr
Facility:
Name:
CHU Nîmes
Address:
City:
Nîmes
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Catherine FERRER
Phone:
+33 (0) 4 66 68 32 16
Email:
catherine.ferrer@chu-nimes.fr
Facility:
Name:
Hôpital Cochin
Address:
City:
Paris
Country:
France
Status:
Recruiting
Contact:
Last name:
Bruno BORGHESE
Phone:
+33(0) 1 44 41 23 17
Email:
bruno.borghese@aphp.fr
Facility:
Name:
Hôpital Européen Georges Pompidou
Address:
City:
Paris
Country:
France
Status:
Recruiting
Contact:
Last name:
Anne-Sophie BATS
Phone:
01 56 09 35 86
Email:
anne-sophie.bats@aphp.fr
Facility:
Name:
Hôpital Lariboisière Saint Louis
Address:
City:
Paris
Country:
France
Status:
Recruiting
Contact:
Last name:
Cyrille HUCHON
Phone:
+33 (0) 1 49 95 62 78
Email:
cyrille.huchon@aphp.fr
Facility:
Name:
Hôpital Pitié-Salpêtrière
Address:
City:
Paris
Country:
France
Status:
Recruiting
Contact:
Last name:
Catherine UZAN
Phone:
01 42 17 81 14
Email:
catherine.uzan@aphp.fr
Facility:
Name:
Institut Curie
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Enora LAAS
Phone:
+33 (0) 1 44 32 46 53
Email:
enora.laas@curie.fr
Facility:
Name:
Hôpital Lyon Sud
Address:
City:
Pierre-Bénite
Country:
France
Status:
Recruiting
Contact:
Last name:
Witold GERTYCH
Phone:
04 78 86 13 82
Email:
witold.gertych@chu-lyon.fr
Facility:
Name:
Centre Henri Becquerel
Address:
City:
Rouen
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Agathe CROUZET
Phone:
+33 (0) 2 32 08 22 22
Email:
agathe.crouzet@chb.unicancer.fr
Facility:
Name:
Institut de Cancérologie de l'Ouest
Address:
City:
Saint-Herblain
Country:
France
Status:
Recruiting
Contact:
Last name:
Cécile LOAEC
Phone:
02 40 67 99 00
Email:
cecile.loaec@ico.unicancer.fr
Facility:
Name:
CHRU Strasbourg - ICANS
Address:
City:
Strasbourg
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Chérif AKLADIOS
Phone:
03 68 76 67 67
Email:
cherif.akladios@chru-strasbourg.fr
Facility:
Name:
Institut Universitaire du Cancer Toulouse - Oncopole
Address:
City:
Toulouse
Zip:
31059
Country:
France
Status:
Recruiting
Contact:
Last name:
Alejandra MARTINEZ
Phone:
+33 5 31 15 53 66
Email:
martinez.alejandra@iuct-oncopole.fr
Facility:
Name:
Chru Tours
Address:
City:
Tours
Country:
France
Status:
Recruiting
Contact:
Last name:
Lobna OULDAMER
Phone:
02 47 47 47 42
Email:
l.ouldamer@chu-tours.fr
Facility:
Name:
Institut Gustave Roussy
Address:
City:
Villejuif
Country:
France
Status:
Recruiting
Contact:
Last name:
Sébastien GOUY
Phone:
01 42 11 47 12
Email:
sebastien.gouy@gustaveroussy.fr
Facility:
Name:
Policlinico Universitario Agostino Gemelli
Address:
City:
Roma
Zip:
00168
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Nicolo BIZZARRI
Email:
nicolo.bizzarri@yahoo.com
Facility:
Name:
Hospital Clinic Barcelona
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Berta DIAZ-FEIJOO
Email:
bdiazfe@clinic.cat
Start date:
December 20, 2023
Completion date:
December 2033
Lead sponsor:
Agency:
Institut Claudius Regaud
Agency class:
Other
Collaborator:
Agency:
ARCAGY/ GINECO GROUP
Agency class:
Other
Collaborator:
Agency:
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Agency class:
Other
Collaborator:
Agency:
Gynecologic Cancer Intergroup (GCIG)
Agency class:
Other
Collaborator:
Agency:
Grupo Español de Investigación en Cáncer de Ovario
Agency class:
Other
Collaborator:
Agency:
Multicenter Italian Trials in Ovarian cancer and gynecologic malignancies
Agency class:
Other
Collaborator:
Agency:
Belgian Gynaecological Oncology Group
Agency class:
Other
Collaborator:
Agency:
Swiss GO Trial Group
Agency class:
Other
Collaborator:
Agency:
Institute of Cancer Research, United Kingdom
Agency class:
Other
Collaborator:
Agency:
The Central and Eastern European Gynecologic Oncology Group
Agency class:
Other
Collaborator:
Agency:
Hellenic Cooperative Oncology Group
Agency class:
Other
Source:
Institut Claudius Regaud
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05581121
