NCT01639820

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 267 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2009-01-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2012-07-13
• Last updated: 2025-12-19

Locations

1 site across 1 country: France