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An Orthotopic Model of Serous Ovarian Cancer in Immunocompetent Mice for in vivo Tumor Imaging and Monitoring of Tumor Immune Responses
Published on: November 28, 2010
Validación de la Técnica del Ganglio Centinela en el Cáncer de Ovario en Etapa Temprana (SENTOV II)
Víctor Lago1, Iria Rey1, Berta Diaz-Feijoo2
1Gynecologic Oncology Unit, University Hospital La Fe, Valencia, Spain; Health Research Institute Hospital La Fe (IIS La Fe), Valencia, Spain.
Background:
Pelvic and para-aortic lymphadenectomy remains the standard procedure for nodal staging in apparent early-stage ovarian cancer, but it is associated with considerable morbidity and lacks clear evidence of improving survival. Sentinel lymph node mapping may offer a less invasive alternative while still enabling accurate upstaging in a sub-set of patients with occult lymph node metastasis.
Primary Objective:
This study aims to evaluate the negative predictive value of the sentinel lymph node technique for detecting lymphatic metastases in early-stage ovarian cancer compared with systematic pelvic and para-aortic lymphadenectomy (gold standard).
Study Hypothesis:
The sentinel lymph node technique is non-inferior to systematic lymphadenectomy for detecting lymphatic metastasis.
Trial Design:
This is a multi-center phase III clinical trial. Eligible patients with confirmed early-stage ovarian cancer will undergoing sentinel lymph node mapping and a subsequently complete staging surgery, including systematic lymphadenectomy. The concordance between both methods will be analyzed.
Major Inclusion/Exclusion Criteria:
Inclusion: Women aged ≥18 years, with histologically confirmed epithelial ovarian malignancy in apparent International Federation of Gynecology and Obstetrics I to II stage, planned for staging surgery either at the time of initial surgery (after intra-operative frozen section confirmation) or after a deferred histologic diagnosis.
Exclusion:
Age <18 years, previous vascular or lymphatic pelvic/aortic surgery, previous lymphoma or abdominopelvic tumors, allergy to Technetium-99m or indocyanine green, pregnancy/lactation.
Primary Endpoint:
Negative predictive value of the sentinel lymph node technique compared to systematic lymphadenectomy for lymph node metastasis.
Sample Size:
The planned sample size is 100 patients with negative sentinel lymph node results to ensure adequate statistical power (80%) to detect a negative predictive value for the sentinel lymph node technique above 95%. An interim analysis will be performed once 50% of the recruitment has been reached to adjust the exact total sample size. Recruitment period is estimated at 24 to 36 months in 11 high-volume Spanish centers.
Estimated Dates For Completing Accrual And Presenting Results:
Patient accrual: November 2025 to November 2028.
Final Results Expected:
January 2029.
Trial Registration:
NCT06963268.
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