Actively Recruiting
German-funded Laparoscopic Approach to Cervical Cancer
Led by Hannover Medical School · Updated on 2025-02-03
756
Participants Needed
14
Research Sites
493 weeks
Total Duration
On this page
Sponsors
H
Hannover Medical School
Lead Sponsor
G
German Cancer Aid
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
German-funded Laparoscopic Approach to Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed primary adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma of the uterine cervix
- FIGO stage IA2, IB1, or IB2 disease less than 4 cm
- Undergoing radical hysterectomy Types II or III (Piver) or Types B or C (Querleu and Morrow), or simple hysterectomy for low-risk early-stage cancer meeting SHAPE criteria
- Performance status ECOG 0-1
- Suitable for surgery with preoperative MRI and available for serious adverse event assessment for 1 year post-surgery
- Signed informed consent
- Prior malignancy only if more than 5 years ago with no evidence of disease
- Female aged 18 years or older
You will not qualify if you...
- Histology other than adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma of the uterine cervix
- Tumor size 4 cm or larger by MRI or clinical exam
- FIGO stage IB3 to IV
- History of pelvic or abdominal radiotherapy
- Evidence of metastatic disease, enlarged pelvic or aortic lymph nodes over 2 cm, or positive lymph nodes
- Serious systemic disorders incompatible with study
- Unable to tolerate prolonged lithotomy and steep Trendelenburg position
- Non-compliance or geographic factors preventing adequate follow-up
- Pregnant women
- Contraindications to surgery
- Secondary invasive neoplasm within 5 years except certain non-melanoma skin cancers or low-risk breast cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Ludwigsburg Hospital, Department of Gynecology and Obstetrics
Ludwigsburg, Baden-Wurttemberg, Germany, 71640
Actively Recruiting
2
University Medical Center Tübingen, Department of Gynecology
Tübingen, Baden-Wurttemberg, Germany, 72076
Actively Recruiting
3
Hochtaunus-Clinics Bad Homburg, Department of Gynecology
Bad Homburg, Hesse, Germany, 61352
Actively Recruiting
4
University Medical Center Göttingen, Department of Gynecology and Obstetrics
Göttingen, Lower Saxony, Germany, 37075
Actively Recruiting
5
Hannover Medical School, Department of Gynecology and Obstetrics
Hanover, Lower Saxony, Germany, 30625
Actively Recruiting
6
Hospital Lüneburg, Department of Gynecology
Lüneburg, Lower Saxony, Germany, 21339
Actively Recruiting
7
Hospital Bielefeld - Center, Department of Gynecology
Bielefeld, North Rhine-Westphalia, Germany, 33604
Actively Recruiting
8
University Medical Center Düsseldorf, Department of Gynecology and Obstetrics
Düsseldorf, North Rhine-Westphalia, Germany, 40225
Actively Recruiting
9
Protestant Hospital Wesel, Gynecological Cancer Center
Wesel, North Rhine-Westphalia, Germany, 46485
Actively Recruiting
10
University Medical Center Mainz, Department of Obstetrics and Gynecology
Mainz, Rhineland-Palatinate, Germany, 55131
Actively Recruiting
11
University Hospital Schleswig-Holstein, Campus Kiel, Department of Gynecology and Obstetrics
Kiel, Schleswig-Holstein, Germany, 24105
Actively Recruiting
12
Vivantes Auguste-Viktoria-Hospital, Department of Gynecology
Berlin Schöneberg, State of Berlin, Germany, 12157
Actively Recruiting
13
Martin Luther Hospital Berlin, Department of Gynecology and Obstetrics
Berlin, Germany, 14193
Actively Recruiting
14
University Medical Center Hamburg-Eppendorf, Department of Gynecology
Hamburg, Germany, 20246
Actively Recruiting
Research Team
P
Peter Hillemanns, Prof. Dr.
CONTACT
O
Oliver Papp
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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