Cervical Cancer Clinical Trial
— SENTICOLIIIOfficial title:
International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer
SENTICOL III is large prospective multicenter international randomized study designed to validate the Sentinel Lymph Node (SLN) mapping technique in early cervical cancer. This "validation study" will compare the outcome of patients with negative SLN (experimental arm) vs patients with negative SLN + Pelvic Lymph Node dissection (PLN)(reference arm). There will be a "quality assurance" program which will be developed in participating centers with detailed requirements in terms of surgeons' qualifications, pathology qualification, SLN ultrastaging, standardization of the procedure, etc. as well as respect of the "safety algorithm".
| Status | Recruiting |
| Enrollment | 988 |
| Est. completion date | May 2029 |
| Est. primary completion date | May 2027 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: I 1. Patient must be = 18 years old, I 2. With squamous or adenocarcinoma or adenosquamous carcinoma of the cervix (proven by biopsy or cone biopsy), I 3. Stage Ia1 with lymphovascular emboli, Ia2, Ib1 IIa1, Ib2 (clinical stage) of the 2018 FIGO classification (see appendix 1), I 4. Maximum diameter = 40 mm by clinical examination and/or magnetic resonance imaging (MRI), I 5. No suspicious node on pelvic MRI with an exploration up to the left renal vein (according to RECIST 1.1), I 6. ECOG performance status 0-2 (see appendix 2), I 7. Signed informed consent and ability to comply with follow-up, I 8. French subjects: in France, a subject will be eligible for inclusion in this study only if either affiliated to, or a beneficiary of, a social security category. Exclusion Criteria: E 1. Pregnancy, E 2. Previous pelvic or abdominal cancer, E 3. Previous chemotherapy and/or radiation therapy for the cervical cancer (previous brachytherapy is accepted), E 4. Proven allergy to blue dye, isotope or indocyanine green (ICG) E 5. Other malignancy within the last 5 years except for treated cancer free of disease and treatment, E 6. Patients with synchronous cancer |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Barretos Cancer Hospital | Campo Grande | |
| Brazil | Hospital Erasto Gaertner | Curitiba | Parana |
| Brazil | Brazilian National Cancer Institute | Rio De Janeiro | |
| Brazil | AC Camargo Cancer Center - Sao Paulo | São Paulo | |
| Brazil | Hospital Amaral Carvalho de Jaù | São Paulo | |
| Brazil | Hospital Israelita Albert Einstein | São Paulo | |
| Canada | CHUM Centre Hospitalier de l'Université de Montréal | Montréal | |
| Canada | CIUSSS de l'Est-de-I'lle-de-Montreal Hopital Maisonneuve-Rosemont (CAHA) | Montréal | |
| Canada | CHU Québec (Hôtel Dieu) | Québec | |
| Canada | Allan Blair Cancer Centre (CASA) | Regina | |
| Canada | Saskatoon Cancer Centre.(CASS) | Saskatoon | |
| Canada | CIUSS de l'Estrie - Centre hospitalier universitaire de Sherbrooke - CAGH | Sherbrooke | |
| Canada | Clinical Research Unit at Vancouver Coastal Health Authority (CAVG) | Vancouver | |
| China | Cancer Hospital of University of Chinese Academy of Science | Hangzhou | Zhejiang |
| China | The 1st Affiliated Hospital | Wenzhou | |
| Czechia | University Hospital Olomouc | Olomouc | |
| Czechia | University Hospital Ostrava | Ostrava-Poruba | |
| Czechia | General University Hospital | Praha | |
| Czechia | University Hospital Bulovka | Praha | |
| France | CHU d'Amiens | Amiens | |
| France | CHU de Besançon | Besançon | |
| France | Clinique Tivoli-Ducos | Bordeaux | |
| France | Institut Bergonié | Bordeaux | |
| France | Center de Lutte Contre le Cancer François Baclesse | Caen | |
| France | CHU de Caen | Caen | |
| France | Hôpital Antoine Béclère | Clamart | |
| France | Centre de Lutte Contre le Cancer Jean Perrin | Clermont-Ferrand | |
| France | CHU de Clermont-Ferrand - Hôpital d'Estaing | Clermont-Ferrand | |
| France | CHI de Créteil | Créteil | |
| France | Centre Georges François Leclerc | Dijon | |
| France | CHU de Dijon Bourgogne | Dijon | |
| France | Hôpital Bicêtre | Le Kremlin-Bicêtre | |
| France | Centre Oscar Lambret | Lille | |
| France | CHRU de Lille - Hôpital Jeanne de Flandre | Lille | |
| France | CHU de Limoges | Limoges | |
| France | Groupement Hospitalier Est - Hôpital Femme Mère Enfant | Lyon | |
| France | Hôpital de la Conception | Marseille | |
| France | Hôpital Saint-Joseph | Marseille | |
| France | Institut Paoli Calmettes | Marseille | |
| France | Institut de Cancérologie de Montpellier Val d'Aurelle | Montpellier | |
| France | CH de Mulhouse - Hôpital du Hasenrain | Mulhouse | |
| France | Institut de Cancérologie de l'Ouest - Centre René Gauducheau | Nantes | |
| France | Centre de Lutte Contre le Cancer Antoine Lacassagne | Nice | |
| France | Centre Hospitalier Bichat - Claude Bernard | Paris | |
| France | Grand Hôpital de l'Est Francilien | Paris | Marne-le-Vallée |
| France | Groupe Hospitalier Diaconesses Croix Saint Simon | Paris | |
| France | Groupe Hospitalier la Pitié Salpêtrière | Paris | |
| France | Hôpital Européen Georges Pompidou | Paris | |
| France | Hôpital Lariboisière | Paris | |
| France | Hôpital Tenon | Paris | |
| France | Institut Curie - site de Paris | Paris | |
| France | CH Lyon Sud | Pierre-Bénite | |
| France | Hôpital de Poissy-Saint-Germain-en-Laye | Poissy | |
| France | CHU de Poitiers - Hôpital de la Milétrie | Poitiers | |
| France | Centre Jean Godinot | Reims | |
| France | CHU de Reims - Hôpital Robert Debré | Reims | |
| France | CHU de Rennes - Hôpital Sud | Rennes | |
| France | Centre Henri Becquerel | Rouen | |
| France | Clinique Mathilde | Rouen | |
| France | CHU de la Réunion | Saint-Denis | La Réunion |
| France | Hôpitaux Universitaires de Strasbourg | Strasbourg | |
| France | Institut Universitaire du Cancer de Toulouse | Toulouse | |
| France | Institut de Cancérologie de Lorraine | Vandoeuvre les nancy | |
| France | Centre de Lutte Contre le Cancer Gustave Roussy | Villejuif | |
| Germany | Vivantes Humboldt-Klinikum | Berlin | |
| Germany | Universitätsklinikum Carl Gustav Carus | Dresden | |
| Germany | Florence-Nightingale-Krankenhaus | Düsseldorf | |
| Germany | Universitätsklinikum Düsseldorf | Düsseldorf | |
| Germany | Kliniken Essen Mitte, Evang. Huyssens-Stiftung | Essen | |
| Germany | Frauenklinik Fürth | Fürth | |
| Germany | Universitätsklinikum Gießen und Marburg - UKGM Giessen | Gießen | |
| Germany | Universitätsklinikum Hamburg-Eppendorf | Hamburg | |
| Germany | Medizinische Hochschule Hannover | Hanover | |
| Germany | Universitätsklinikum Jena | Jena | |
| Germany | Städtisches Klinikum Karlsruhe | Karlsruhe | |
| Germany | Klinikum Kassel | Kassel | |
| Germany | Universitätsklinikum Schleswig-Holstein, Campus Lübeck | Lübeck | |
| Germany | Klinikum der Universität München | München | |
| Germany | Universitätsklinikum Münster | Münster | |
| Germany | UFK am Klinikum Südstradt Rostock | Rostock | |
| Germany | Universitaätsklinikum Tübingen | Tübingen | |
| Germany | Universitätsklinikum Ulm | Ulm | |
| Germany | Klinikum Wolfsburg | Wolfsburg | |
| India | Basavatarakam Indo-American Cancer Hospital & Research Institute | Hyderabad | Telangana |
| India | Chittaranjan National Cancer Institute (CNCI) | Kolkata | West Bengal |
| Italy | Istituto Europe di Oncologia | Milano | |
| Italy | Ospedale San Gerardo Monza | Monza | |
| Japan | Saitama Medical University International Medical Center | Saitama | |
| Norway | Oslo Universitetssykehus HF Radiumhospitalet | Oslo | |
| Slovakia | National Oncology Institute | Bratislava | |
| Slovakia | University Hospital Bratislava | Bratislava | |
| Slovakia | University Hospital Trencin | Trencín | |
| Spain | Hospital Clinic de Barcelona | Barcelona | |
| Spain | Hospital Universitario Vall D´Hebron | Barcelona | |
| Spain | Hospital General Universitario de Castellón | Castelló de la Plana | |
| Spain | Hospital Universitario de Donostia | Donostia | |
| Spain | Hopital Clinico Universitario de Valencia | Girona | |
| Spain | Hospital Clínico Universitario San Carlos | Madrid | |
| Spain | Hospital Ramón y Caja | Madrid | |
| Spain | Hospital Universitario 12 de Octubre | Madrid | |
| Spain | Hospital Universitario La Paz | Madrid | |
| Spain | Hospital Alvaro Cunqueiro | Vigo | |
| Switzerland | CHUV | Lausanne |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire de Besancon | ARCAGY/ GINECO GROUP, European Network of Gynaecological Oncological Trial Groups (ENGOT) |
Brazil, Canada, China, Czechia, France, Germany, India, Italy, Japan, Norway, Slovakia, Spain, Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Disease Free Survival (DFS) | Composite outcome: the time interval between randomization and recurrence (local/distant) or second cancer or death (all causes), whichever occurs first.
This time interval will be analysed concomitantly with HR-QoL scores as a composite outcome. |
Year 3 | |
| Primary | Health-related quality of life (HR-QoL) | Composite outcome: significant deterioration will specifically be assessed through 3 targeted dimensions (pain score, global health score and physical functioning scores) in EORTC QLQ-C30 and QLQ-CX24 questionnaires.
These scores will be analysed concomitantly with DFS as a composite outcome. |
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