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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 : 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

Tracking Information
First Submitted Date  ICMJE December 15, 2017
First Posted Date  ICMJE December 29, 2017
Last Update Posted Date March 27, 2024
Actual Study Start Date  ICMJE May 3, 2018
Estimated Primary Completion Date May 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2017)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer
Official Title  ICMJE International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer
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".

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE Cervical Cancer
Intervention  ICMJE
  • 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.
  • Procedure: SLN biopsy + PLN dissection
    In active comparator arm, SLN dissection + full lymphadenectomy will be performed.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: SLN biopsy only
  • 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.
    Intervention: Procedure: SLN biopsy + PLN dissection
Publications * Lecuru FR, McCormack M, Hillemanns P, Anota A, Leitao M, Mathevet P, Zweemer R, Fujiwara K, Zanagnolo V, Zahl Eriksson AG, Hudson E, Ferron G, Plante M. SENTICOL III: an international validation study of sentinel node biopsy in early cervical cancer. A GINECO, ENGOT, GCIG and multicenter study. Int J Gynecol Cancer. 2019 May;29(4):829-834. doi: 10.1136/ijgc-2019-000332. Epub 2019 Mar 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 27, 2022)
988
Original Estimated Enrollment  ICMJE
 (submitted: December 21, 2017)
950
Estimated Study Completion Date  ICMJE May 2029
Estimated Primary Completion Date May 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sixtine Genel 0033184852016 sgenel@arcagy.org
Contact: Kristina Mouyabi 0033381218356 kmouyabi@chu-besancon.fr
Listed Location Countries  ICMJE Brazil,   Canada,   China,   Czechia,   France,   Germany,   India,   Italy,   Japan,   Norway,   Slovakia,   Spain,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03386734
Other Study ID Numbers  ICMJE N/2016/72
ENGOT-Cx4 ( Other Identifier: ENGOT )
GINECO-CE106 ( Other Identifier: GINECO )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Centre Hospitalier Universitaire de Besancon
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Centre Hospitalier Universitaire de Besancon
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • ARCAGY/ GINECO GROUP
  • European Network of Gynaecological Oncological Trial Groups (ENGOT)
Investigators  ICMJE
Principal Investigator: Fabrice Lecuru, MD PhD Institut Curie
PRS Account Centre Hospitalier Universitaire de Besancon
Verification Date February 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP