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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 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 267

Last updated 2025-12-19

No results posted yet for this study

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

Interventions

PROCEDURE

identification of sentinel nodes + full pelvic lymph-node dissection

identification of sentinel nodes + full pelvic lymph-node dissection

PROCEDURE

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

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

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01639820 on ClinicalTrials.gov