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

NCT01639820 | Completed

• 1 other identifier: 2008.515
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 1

Brief Summary

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

Uterine Cervical Dysplasia

Keywords

Cervical cancer; early stage carcinoma; FIGO IA1 IA2 IB1 IIA; sentinel lymph node biopsy; pelvic lymphadenectomy; Surgery of uterine cervical carcinoma; medico economic impact; quality of life

Outcome Measures

Primary Outcomes (1)

• Number of Participants with complications observed in the 2 arms during the per and post-operative period up to 6 months

  6 months after surgery

Secondary Outcomes (7)

• Score of the questionnaire of quality of life at 30 days, 3 months and 6 months after surgery

  30 days, 3 months and 6 months after surgery

• the costs of both studied strategies

  At the surgery until 6 months

• the detection rate of the sentinel node technique in the 2 arms

  Day 1

• the false negative rate in the control arm

  Day 1

• the sites of recurrence for each strategy

  Day 1

Study Arms (2)

Strategy A

EXPERIMENTAL

Only identification of sentinel nodes (without pelvic lymph-node dissection)

Procedure: only identification of sentinel nodes (without pelvic lymph-node dissection)

Strategy B

OTHER

Identification of sentinel nodes + full pelvic lymph-node dissection

Procedure: identification of sentinel nodes + full pelvic lymph-node dissection

Interventions

identification of sentinel nodes + full pelvic lymph-node dissection PROCEDURE

identification of sentinel nodes + full pelvic lymph-node dissection

Strategy B

only identification of sentinel nodes (without pelvic lymph-node dissection) PROCEDURE

only identification of sentinel nodes (without pelvic lymph-node dissection)

Strategy A

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service de Gynécologie, Hôpital Femme Mère Enfant

Bron, 69677, France

Location

Related Publications (2)

• 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.

  PMID: 25727652 RESULT

• 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.

  PMID: 33773275 RESULT

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2010
• First Posted: July 13, 2012
• Study Start: January 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

FR (1)