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German-funded Laparoscopic Approach to Cervical Cancer

NCT06489795 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 756

Last updated 2025-02-03

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • German Cancer Aid

    collaborator OTHER

  • Hannover Medical School

    lead OTHER

Principal Investigators

  • Peter Hillemanns, Prof. Dr. · Hannover Medical School, Department of Gynecology and Obstetrics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-17
Primary Completion
2033-07-31
Completion
2034-01-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT06489795 on ClinicalTrials.gov