Sentinel Lymph Node Biopsy Versus Pelvic Lymphadenectomy in Early-stage Cervical Cancer (PHENIX/CSEM 010)
NCT02642471 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1080
Last updated 2024-12-16
Summary
The diagnostic value of sentinel lymph node biopsy in early-stage cervical cancer has been well studied. However, there were no randomized controlled study on comparing the long-term outcomes of sentinel lymph node biopsy and conventional procedure. The investigators perform a phase III, randomized controlled trial to determine whether pelvic lymphadenectomy can be replaced by sentinel lymph node biopsy in surgical treatment for patients with early-stage cervical cancer.
Conditions
- Cervical Cancer
- Surgery
- Quality of Life
Interventions
- PROCEDURE
-
no systematic pelvic lymphadenectomy
systematic pelvic lymphadenectomy is omitted in surgical treatment
Sponsors & Collaborators
-
Sun Yat-sen University
lead OTHER
Principal Investigators
-
Jihong Liu, Ph. D · Sun Yat-sen University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-12-31
- Primary Completion
- 2024-12-31
- Completion
- 2024-12-31
Countries
- China
Study Locations
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