Overview
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".
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