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".

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHC MontLégia, Liège, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SLN biopsy only

Procedure

In experimental arm, SLN dissection only. A full lymphadenectomy will not be performed. The radical hysterectomy or trachelectomy will be done.

SLN biopsy + PLN dissection

Procedure

In active comparator arm, SLN dissection + full lymphadenectomy will be performed.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Collaborators

ARCAGY/ GINECO GROUP
European Network of Gynaecological Oncological Trial Groups (ENGOT)

Registry information

Acronym: SENTICOLIII

Important dates

Study start: 2018
Primary completion: 2027
Study completion: 2029
First posted: Dec 29, 2017
Registry last updated: Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting