Comparison of Pelvic Lymphadenectomy Versus Isolated Sentinel Lymph Node Biopsy Procedure for Early Stages of Cervical Cancers : a Multicenter Study With Evaluation of Medico-economic Impacts
NCT ID: NCT01639820
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
267 participants
INTERVENTIONAL
2009-01-31
2012-12-31
Brief Summary
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The experimental arm is only sentinel node identification + radical hysterectomy.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Strategy A
Only identification of sentinel nodes (without pelvic lymph-node dissection)
only identification of sentinel nodes (without pelvic lymph-node dissection)
only identification of sentinel nodes (without pelvic lymph-node dissection)
Strategy B
Identification of sentinel nodes + full pelvic lymph-node dissection
identification of sentinel nodes + full pelvic lymph-node dissection
identification of sentinel nodes + full pelvic lymph-node dissection
Interventions
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identification of sentinel nodes + full pelvic lymph-node dissection
identification of sentinel nodes + full pelvic lymph-node dissection
only identification of sentinel nodes (without pelvic lymph-node dissection)
only identification of sentinel nodes (without pelvic lymph-node dissection)
Eligibility Criteria
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Inclusion Criteria
* Absence of contraindication to laparoscopy,
* Uterine cervical carcinoma (every histological type except neuroendocrine),
* Stage IA1 with lymphatic tumor space involvement (LVSI) or IA2 diagnosed on cervical conization; or stage IA2, IB1 or IIA detected by clinical examination, confirmed by biopsy and measured by the MRI, the highest diameter being lower to 4 cm (a preoperative brachytherapy is allowed for tumors 2 to 4 cm in diameter),
* Negative pregnancy test for women able to procreate,
* Having the French National Social Security
* Signed informed consent
Exclusion Criteria
* In situ carcinoma or stage IA1 without LVSI,
* Maximal tumoral diameter measured by MRI more than 4 cm,
* Stage IB1 by "down-staging",
* Stage IB2, IIB to IVB, including those who had a response to neoadjuvant treatment (chemotherapy or RT + chemotherapy) ,
* Presence of distant metastases,
* Progression of the cervical cancer or recurrence,
* History of pelvic lymphadenectomy,
* Other cancer diagnosed during the course of treatment,
* Contraindication to the injected products : allergy known to Patent Blue or rhenium sulfide,
* History of severe allergy (history of Quincke's edema, anaphylactic shock),
* Patient who does not understand, speak or write the French language,
* Pregnant woman
18 Years
FEMALE
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Service de Gynécologie, Hôpital Femme Mère Enfant
Bron, , France
Countries
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References
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Bats AS, Frati A, Mathevet P, Orliaguet I, Querleu D, Zerdoud S, Leblanc E, Gauthier H, Uzan C, Deandreis D, Darai E, Kerrou K, Marret H, Lenain E, Froissart M, Lecuru F. Contribution of lymphoscintigraphy to intraoperative sentinel lymph node detection in early cervical cancer: Analysis of the prospective multicenter SENTICOL cohort. Gynecol Oncol. 2015 May;137(2):264-9. doi: 10.1016/j.ygyno.2015.02.018. Epub 2015 Feb 26.
Mathevet P, Lecuru F, Uzan C, Boutitie F, Magaud L, Guyon F, Querleu D, Fourchotte V, Baron M, Bats AS; Senticol 2 group. Sentinel lymph node biopsy and morbidity outcomes in early cervical cancer: Results of a multicentre randomised trial (SENTICOL-2). Eur J Cancer. 2021 May;148:307-315. doi: 10.1016/j.ejca.2021.02.009. Epub 2021 Mar 24.
Other Identifiers
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2008.515
Identifier Type: -
Identifier Source: org_study_id