International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer (SENTICOLIII)
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|ClinicalTrials.gov Identifier: NCT03386734|
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : July 28, 2022
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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".
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Procedure: SLN biopsy only Procedure: SLN biopsy + PLN dissection||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||988 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer|
|Actual Study Start Date :||May 3, 2018|
|Estimated Primary Completion Date :||May 2027|
|Estimated Study Completion Date :||May 2029|
Experimental: SLN biopsy only
Sentinel lymph node (SLN) biopsy only. A full lymphadenectomy will not be performed. The radical hysterectomy or trachelectomy will be done.
Procedure: SLN biopsy only
In experimental arm, SLN dissection only. A full lymphadenectomy will not be performed. The radical hysterectomy or trachelectomy will be done.
Active Comparator: SLN biopsy + PLN dissection
SLN biopsy + full pelvic lymph node dissection (PLN) will be performed. The radical hysterectomy or trachelectomy will be done.
Procedure: SLN biopsy + PLN dissection
In active comparator arm, SLN dissection + full lymphadenectomy will be performed.
- Disease Free Survival (DFS) [ Time Frame: Year 3 ]
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.
- Health-related quality of life (HR-QoL) [ Time Frame: Year 3 ]
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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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
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.
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03386734
|Contact: Alexandra Rohelemail@example.com|
|Contact: Kristina Mouyabifirstname.lastname@example.org|
|Principal Investigator:||Fabrice Lecuru, MD PhD||Institut Curie|
|Responsible Party:||Centre Hospitalier Universitaire de Besancon|
|Other Study ID Numbers:||
ENGOT-Cx4 ( Other Identifier: ENGOT )
GINECO-CE106 ( Other Identifier: GINECO )
|First Posted:||December 29, 2017 Key Record Dates|
|Last Update Posted:||July 28, 2022|
|Last Verified:||July 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Uterine Cervical Neoplasms
Genital Neoplasms, Female
Neoplasms by Site
Uterine Cervical Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications