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German-funded Laparoscopic Approach to Cervical Cancer
Sponsor: Hannover Medical School
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
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.
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