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Clinical Trial
SENTICOL III: an international validation study of sentinel node biopsy in early cervical cancer. A GINECO, ENGOT, GCIG and multicenter study
  1. Fabrice R Lecuru1,
  2. Mary McCormack2,
  3. Peter Hillemanns3,
  4. Amelie Anota4,
  5. Mario Leitao5,
  6. Patrice Mathevet6,
  7. Ronald Zweemer7,
  8. Keiichi Fujiwara8,
  9. Vanna Zanagnolo9,
  10. Ane Gerda Zahl Eriksson10,
  11. Emma Hudson11,
  12. Gwenael Ferron12 and
  13. Marie Plante13
  1. 1 Gynecologic and Oncologic Surgery, GINECO, Georges Pompidou European Hospital, Paris, France
  2. 2 NRCI, UK, UCLH London, London, UK
  3. 3 Klinik fur Frauenheilkunde und Geburtshilfe, AGO, Medizinische Hochschule, Hannover, Germany
  4. 4 Statistics, GINECO, Centre Hospitalier Universitaire de Besancon, Besancon, France
  5. 5 Gynecologic Oncology, Memorial Sloan-Kettering Cancer Center, New York City, New York, USA
  6. 6 Centre Hospitalier Universitaire Vaudois Departement de gynecologie-obstetrique et genetique medicale, Lausanne, Switzerland
  7. 7 Gynecologic Oncology, DGOG, UMC Utrecht Hersencentrum Rudolf Magnus, Utrecht, UK
  8. 8 Gynecologic Oncology, GOTIC, Saitama Medical University, Moroyama, UK
  9. 9 Gynecologic Oncology, MANGO, Istituto Europeo di Oncologia, Milano, Italy
  10. 10 Gynecologic Oncology, NSGO, Universitetet i Oslo, Oslo, Norway
  11. 11 Gynecologic Oncology, NRCI, Velindre Cancer Centre, Cardiff, UK
  12. 12 Gynecologic Oncology, GINECO, Institut Universitaire du Cancer Toulouse Oncopole, Toulouse, France
  13. 13 Gynecologic Oncology, CCTG, Fondation du CHU de Quebec, Quebec City, Quebec, Canada
  1. Correspondence to Professor Fabrice R Lecuru, Gynecologic and Oncologic Surgery, GINECO, Georges Pompidou European Hospital, Paris 75013, France; fabrice.lecuru{at}aphp.fr

Abstract

Background Radical hysterectomy and complete pelvic lymphadenectomies are the most commonly performed procedures for women with early-stage cervical cancer. Sentinel lymph node (SLN) mapping could be an alternative to routine pelvic lymphadenectomy, aiming to diagnose accurately nodal extension and decrease lymphatic morbidity.

Primary Objective To compare 3-year disease-free survival and health-related quality of life after SLN biopsy or SLN biopsy + pelvic lymphadenectomy in early cervical cancer.

Study Hypothesis We hypothesize that disease-free survival is non-inferior and health-related quality of life superior after SLN biopsy compared with SLN biopsy + pelvic lymphadenectomy.

Trial Design International, randomized, multicenter, single-blind trial. The study will be run by teams trained to carry out SLN biopsy, belonging to clinical research cooperative groups or recognized as experts in this field. Patients with an optimal mapping (Memorial Sloan Kettering Cancer Center [MSKCC] criteria) and a negative frozen section will be randomized 1:1 to SLN biopsy only or SLN biopsy + pelvic lymphadenectomy.

Inclusion, Exclusion Criteria Patients with early stages (Ia1 with lymphovascular invasion to IIa1) of disease. Histological types are limited to squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.

Primary Endpoint Main endpoint will be co-primary endpoint, associating 3-year disease-free survival and quality of life (QLQ-C30 and QLQ-CX24).

Sample Size 950 patients need to be randomized.

Estimated dates for completing accrual and presenting results: study started on Q2 2018, last accrual is scheduled for Q2 2021, and last follow-up in Q2 2026.

Trial registration ClinicalTrials.gov identifier: NCT03386734.

  • sentinel lymph node
  • cervical cancer
  • quality of life (pro)/palliative care
  • neoplasm micrometastasis
  • surgical oncology

https://doi.org/10.1136/ijgc-2019-000332

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    Footnotes

    • Contributors All the authors will participate in the trial and lead it in their respective country. FL was responsible for writing the manuscript, which has been validated by all authors.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Provenance and peer review Commissioned; internally peer reviewed.