Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06489795
NA

German-funded Laparoscopic Approach to Cervical Cancer

Sponsor: Hannover Medical School

View on ClinicalTrials.gov

Summary

The G-LACC trial is a prospective, interventional, multicenter, open-label, randomized and controlled non-inferiority operative trial. The main goal of this clinical trial is to evaluate the non-inferiority of minimally invasive radical hysterectomy in contrast to abdominal radical hysterectomy in patients with early-stage cervical cancer. In the case of SHAPE criteria, surgery may also be performed as minimally invasive or abdominal simple hysterectomy. The primary criterion for assessment is disease-free survival (DFS). As secondary outcomes, overall survival (OS), disease recurrence, quality of life, intra-/postoperative complications, and serious adverse events are recorded for assessment.

Official title: A Randomized Clinical Trial Comparing Laparoscopic or Robot-assisted Radical/Simple Hysterectomy Versus Abdominal Radical/Simple Hysterectomy in Patients With Early-stage Cervical Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

756

Start Date

2024-07-17

Completion Date

2034-01

Last Updated

2025-02-03

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

Laparoscopic or robot-assisted radical/simple hysterectomy

In the experimental arm, patients with early-stage cervical cancer will be treated by using laparoscopic or robot-assisted radical, or in the case of SHAPE criteria, simple hysterectomy.

PROCEDURE

Abdominal radical/simple hysterectomy

In the control arm, patients with early-stage cervical cancer will be treated by using abdominal radical, or in the case of SHAPE criteria, simple hysterectomy as standard therapy.

Locations (14)

Ludwigsburg Hospital, Department of Gynecology and Obstetrics

Ludwigsburg, Baden-Wurttemberg, Germany

University Medical Center Tübingen, Department of Gynecology

Tübingen, Baden-Wurttemberg, Germany

Hochtaunus-Clinics Bad Homburg, Department of Gynecology

Bad Homburg, Hesse, Germany

University Medical Center Göttingen, Department of Gynecology and Obstetrics

Göttingen, Lower Saxony, Germany

Hannover Medical School, Department of Gynecology and Obstetrics

Hanover, Lower Saxony, Germany

Hospital Lüneburg, Department of Gynecology

Lüneburg, Lower Saxony, Germany

Hospital Bielefeld - Center, Department of Gynecology

Bielefeld, North Rhine-Westphalia, Germany

University Medical Center Düsseldorf, Department of Gynecology and Obstetrics

Düsseldorf, North Rhine-Westphalia, Germany

Protestant Hospital Wesel, Gynecological Cancer Center

Wesel, North Rhine-Westphalia, Germany

University Medical Center Mainz, Department of Obstetrics and Gynecology

Mainz, Rhineland-Palatinate, Germany

University Hospital Schleswig-Holstein, Campus Kiel, Department of Gynecology and Obstetrics

Kiel, Schleswig-Holstein, Germany

Vivantes Auguste-Viktoria-Hospital, Department of Gynecology

Berlin Schöneberg, State of Berlin, Germany

Martin Luther Hospital Berlin, Department of Gynecology and Obstetrics

Berlin, Germany

University Medical Center Hamburg-Eppendorf, Department of Gynecology

Hamburg, Germany