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International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer (SENTICOLIII)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03386734
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : March 27, 2024
Sponsor:
Collaborators:
ARCAGY/ GINECO GROUP
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Study Description
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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 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 988 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


  2. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Sixtine Genel 0033184852016 sgenel@arcagy.org
Contact: Kristina Mouyabi 0033381218356 kmouyabi@chu-besancon.fr

Locations
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Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
ARCAGY/ GINECO GROUP
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Investigators
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Principal Investigator: Fabrice Lecuru, MD PhD Institut Curie
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03386734    
Other Study ID Numbers: N/2016/72
ENGOT-Cx4 ( Other Identifier: ENGOT )
GINECO-CE106 ( Other Identifier: GINECO )
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: March 27, 2024
Last Verified: February 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
 Uterine Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases