TY - JOUR
T1 - SENTICOL III
T2 - An international validation study of sentinel node biopsy in early cervical cancer. A GINECO, ENGOT, GCIG and multicenter study
AU - Lecuru, Fabrice R.
AU - McCormack, Mary
AU - Hillemanns, Peter
AU - Anota, Amelie
AU - Leitao, Mario
AU - Mathevet, Patrice
AU - Zweemer, Ronald
AU - Fujiwara, Keiichi
AU - Zanagnolo, Vanna
AU - Zahl Eriksson, Ane Gerda
AU - Hudson, Emma
AU - Ferron, Gwenael
AU - Plante, Marie
PY - 2019/5/1
Y1 - 2019/5/1
N2 - 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.
AB - 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.
KW - cervical cancer
KW - neoplasm micrometastasis
KW - quality of life (pro)/palliative care
KW - sentinel lymph node
KW - surgical oncology
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U2 - 10.1136/ijgc-2019-000332
DO - 10.1136/ijgc-2019-000332
M3 - Article
C2 - 30898938
AN - SCOPUS:85065808943
VL - 29
SP - 829
EP - 834
JO - International Journal of Gynecological Cancer
JF - International Journal of Gynecological Cancer
SN - 1048-891X
IS - 4
ER -