Status:
ACTIVE_NOT_RECRUITING
International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer
Lead Sponsor:
Centre Hospitalier Universitaire de Besancon
Collaborating Sponsors:
ARCAGY/ GINECO GROUP
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2029
Estimated Enrollment :
989 Patients enrolled
Trial Details
Trial ID
NCT03386734
Start Date
May 3 2018
End Date
May 1 2029
Last Update
July 8 2024
Active Locations (106)
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1
CHC MontLégia
Liège, Belgium, 4000
2
Hospital Erasto Gaertner
Curitiba, Paraná, Brazil
3
Barretos Cancer Hospital
Campo Grande, Brazil, 79085-039
4
Brazilian National Cancer Institute
Rio de Janeiro, Brazil, 3709