MedTrace Logo

Endometrial Cancer Lymphadenectomy Trial

NCT03438474 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 640

Last updated 2024-11-25

No results posted yet for this study

Summary

The primary aim of this trial is to ascertain whether or not systematic pelvic and para-aortic lymphadenectomy (LNE) does have a significant impact on overall survival (OS) in patients with endometrial cancer (EC) FIGO Stages I or II and high risk of recurrence. Secondary aims will be to evaluate the effect of LNE on disease free survival (DFS) and quality of life, as well as the complications and side effects of LNE and the number of resected lymphnodes. 640 patients with histologically confirmed EC with high risk of recurrence (stage pT1b - pT2, all histological subtypes; pT1a, G3 endometrioid or serous or clear cell EC or carcinosarcomas) will be randomized. In Arm A, a total hysterectomy and bilateral salpingo-oophorectomy and in case of serous or clear cell EC additionally an omentectomy will be performed. In arm B in addition a systematic pelvic and para-aortic LNE up to the level of the left renal vein will be performed.

Conditions

  • Cancer of Endometrium Stage I
  • Cancer of Endometrium Stage II

Interventions

PROCEDURE

Standard surgical procedure for endometrial cancer

total hysterectomy, bilateral salpingo-oophorectomy, omentectomy (type 2 cancers)

PROCEDURE

systematic lymphadenectomy (LNE)

systematic pelvic and para-aortic lymphadenectomy (LNE) up to the renal vessels

Sponsors & Collaborators

  • German Cancer Aid

    collaborator OTHER

  • Philipps University Marburg

    lead OTHER

Principal Investigators

  • Philipp Harter, Professor MD · Kliniken Essen Mitte, Gynäkologie und gynäkologische Onkologie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-28
Primary Completion
2028-02-15
Completion
2029-02-15

Countries

  • Germany
  • Japan
  • South Korea

Study Locations

More Related Trials

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 NCT03438474 on ClinicalTrials.gov