SENTICOL III: an international validation study of sentinel node biopsy in early cervical cancer. A GINECO, ENGOT, GCIG and multicenter study.

Détails

ID Serval
serval:BIB_5A273BC9D3DE
Type
Article: article d'un périodique ou d'un magazine.
Sous-type
Synthèse (review): revue aussi complète que possible des connaissances sur un sujet, rédigée à partir de l'analyse exhaustive des travaux publiés.
Collection
Publications
Titre
SENTICOL III: an international validation study of sentinel node biopsy in early cervical cancer. A GINECO, ENGOT, GCIG and multicenter study.
Périodique
International journal of gynecological cancer
Auteur(s)
Lecuru F.R., McCormack M., Hillemanns P., Anota A., Leitao M., Mathevet P., Zweemer R., Fujiwara K., Zanagnolo V., Zahl Eriksson A.G., Hudson E., Ferron G., Plante M.
ISSN
1525-1438 (Electronic)
ISSN-L
1048-891X
Statut éditorial
Publié
Date de publication
05/2019
Peer-reviewed
Oui
Volume
29
Numéro
4
Pages
829-834
Langue
anglais
Notes
Publication types: Journal Article
Publication Status: ppublish
Résumé
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.
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.
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.
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.
Patients with early stages (Ia1 with lymphovascular invasion to IIa1) of disease. Histological types are limited to squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.
Main endpoint will be co-primary endpoint, associating 3-year disease-free survival and quality of life (QLQ-C30 and QLQ-CX24).
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.
ClinicalTrials.gov identifier: NCT03386734.
Mots-clé
cervical cancer, neoplasm micrometastasis, quality of life (pro)/palliative care, sentinel lymph node, surgical oncology
Pubmed
Web of science
Création de la notice
15/04/2019 7:44
Dernière modification de la notice
20/08/2019 14:13
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