Phase
Condition
Carcinoma
Adenocarcinoma
Cervical Cancer
Treatment
Experimental arm
Standard treatment: Control arm
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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-positivepelvic nodes and FDG-negative PALN including equivocal lymph nodes in the commoniliac and para-aortic regions. The highest positive lymph node must be locatedinferior 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 fromsurgical staging (either intraoperative assessment (frozen section) or from finalhistology - patients are not eligible after radical hysterectomy, and FDG-negativecommon iliac of para-aortic lymph node on PET/CT (performed before or after SLNprocedure)
Patient eligible for pelvic radiotherapy and cisplatin-based chemotherapy with acurative intent as confirmed by a multidisciplinary board
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 QualityAssurance Comity
Women should be post-menopaused or willing to accept the use of an effectivecontraceptive regimen during the treatment period. All non-menopaused women shouldhave 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 thestudy including undergoing treatment and scheduled visits and examinations includingfollow up
Not applicable since protocol revision V4. Patient participating to other clinicaltrials including immunotherapy strategies or adjuvant chemotherapy is also eligiblefor 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).
Exclusion
Exclusion Criteria:
Unequivocal positive common iliac or para-aortic lymph nodes at pretherapeuticimaging 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 adenosquamouscarcinoma
Contraindication for cisplatin-based chemotherapy
Women who received any prior treatment for cervical cancer
Prior surgery for the cervical cancer, except for cone procedure and pelvic lymphnode staging
Previous pelvic radiotherapy
History of another primary malignancy except for: Malignancy treated with curativeintent and with no known active disease after 5 years, adequately treatednon-melanoma skin cancer or lentigo maligna without evidence of disease, adequatelytreated carcinoma in situ (any location) without evidence of disease.
Any psychological, familial, geographic or social situation, according to thejudgment of investigator, potentially preventing the provision of informed consentor compliance to study procedure
Patient who has forfeited his/her freedom by administrative or legal award or who isunder legal protection (curatorship and guardianship, protection of justice).
Study Design
Connect with a study center
Institut de Cancérologie de l'Ouest
Angers,
FranceActive - Recruiting
Institut Bergonié
Bordeaux,
FranceActive - Recruiting
CHU Brest
Brest,
FranceActive - Recruiting
Centre Hospitalier Intercommunal de Créteil
Créteil,
FranceActive - Recruiting
Centre Georges François Leclerc
Dijon,
FranceActive - Recruiting
CHRU Lille
Lille,
FranceActive - Recruiting
Centre Oscar Lambret
Lille,
FranceActive - Recruiting
CHU Limoges
Limoges,
FranceActive - Recruiting
Centre Léon Bérard
Lyon,
FranceActive - Recruiting
Institut Paoli Calmettes
Marseille,
FranceActive - Recruiting
ICM Val d'Aurelle
Montpellier,
FranceActive - Recruiting
CHU Nîmes
Nîmes,
FranceSite Not Available
Hôpital Cochin
Paris,
FranceActive - Recruiting
Hôpital Européen Georges Pompidou
Paris,
FranceActive - Recruiting
Hôpital Lariboisière Saint Louis
Paris,
FranceActive - Recruiting
Hôpital Pitié-Salpêtrière
Paris,
FranceActive - Recruiting
Hôpital Saint Louis
Paris,
FranceSite Not Available
Institut Curie
Paris,
FranceActive - Recruiting
Hôpital Lyon Sud
Pierre-Bénite,
FranceActive - Recruiting
Centre Henri Becquerel
Rouen,
FranceSite Not Available
Institut de Cancérologie de l'Ouest
Saint-Herblain,
FranceActive - Recruiting
CHRU Strasbourg
Strasbourg,
FranceSite Not Available
CHRU Strasbourg - ICANS
Strasbourg,
FranceSite Not Available
Institut Universitaire du Cancer Toulouse - Oncopole
Toulouse, 31059
FranceActive - Recruiting
Chru Tours
Tours,
FranceActive - Recruiting
Institut Gustave Roussy
Villejuif,
FranceActive - Recruiting
Policlinico Universitario Agostino Gemelli
Roma, 00168
ItalySite Not Available
Hospital Clinic Barcelona
Barcelona, 08036
SpainSite Not Available
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