Clinical trial · Interventional
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
Comparison of Pelvic Lymphadenectomy Versus Isolated Sentinel Lymph Node Biopsy Procedure for Early Stages of Cervical Cancers : a Randomized Multicenter Study With Evaluation of Medico-economic Impacts
NCT01639820CI-TRIAL-00099330SENTICOL2completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Patients with early cervical cancer are usually treated with radical hysterectomy + pelvic lymph-node dissection. The study randomizes patients in 2 arms. The control arm is the classical surgical treatment including identification of the sentinel nodes, full pelvic lymph-node dissection and radical hysterectomy. The experimental arm is only sentinel node identification + radical hysterectomy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Cervical Dysplasia | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| identification of sentinel nodes + full pelvic lymph-node dissection | Procedure | — | UNRESOLVED |
| only identification of sentinel nodes (without pelvic lymph-node dissection) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Strategy A
- description
- Only identification of sentinel nodes (without pelvic lymph-node dissection)
- interventionNames
- Procedure: only identification of sentinel nodes (without pelvic lymph-node dissection)
- type
- OTHER
- label
- Strategy B
- description
- Identification of sentinel nodes + full pelvic lymph-node dissection
- interventionNames
- Procedure: identification of sentinel nodes + full pelvic lymph-node dissection
Primary outcomes (1)
- measure
- Number of Participants with complications observed in the 2 arms during the per and post-operative period up to 6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women 18 years of age or older, * 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: * Neuroendocrine carcinoma, * 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
References
Publications (2)
- RESULTBats 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. PMID 25727652
- RESULTMathevet 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. PMID 33773275