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Clinical Trials in Germany / NCT06489795
Recruiting Not applicable

German-funded Laparoscopic Approach to Cervical Cancer

NCT06489795 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2024-07-17
Last updated
2025-02-03

Condition(s) studied

Cervical Cancer

Investigational drug(s) / intervention(s)

Laparoscopic or robot-assisted radical/simple hysterectomyAbdominal radical/simple hysterectomy

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.

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Histologically confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix 2. Patients with FIGO stage IA2, IB1, or IB2 disease (\<4 cm) 3. Patients undergoing radical hysterectomy according either to Type II or III (Piver Classification) or to Type B or C (Querleu and Morrow classification) OR Simple hysterectomy can be considered for patients with low-risk early-stage cervical cancer (SHAPE criteria: tumor \< 2cm, \< 10 mm depth of stromal invasion (LEEP/cone). Simple hysterectomy has to be performed as extrafascial hysterectomy and the preparation of a max. 5mm vaginal cuff is required to ensure negative margins. 4. Performance status of ECOG 0-1 5. Patient must be suitable candidates for surgery with preoperative MRI and available for assessment of serious adverse events up to one year post-surgery 6. Patients who have signed an approved Informed Consent 7. Patients with a prior malignancy only if \> 5 years previous with no evidence of disease 8. Females, aged 18 years or older Exclusion Criteria: 1. Any histology other than an adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma of the uterine cervix 2. Tumor size of 4 cm and greater, estimated by either magnetic resonance imaging (MRI) or clinical examination 3. FIGO stage IB3 - IV 4. Patients with a history of pelvic or abdominal radiotherapy 5. Patients with evidence of metastatic disease by conventional imaging studies, enlarged pelvic or aortic lymph nodes \> 2 cm, or histologically positive lymph nodes 6. Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator) 7. Patients unable to withstand prolonged lithotomy and steep Trendelenburg position 8. Patient compliance and geographic proximity that do not allow adequate follow-up 9. Women who are pregnant 10. Patients with contraindications to surgery 11. Patients with secondary invasive neoplasm in the last 5 years (except non-melanoma skin cancer, breast cancer T1 N0 M0 grade 1 or 2 without any signs of recurrence or activity)

Primary outcome measure(s)

Trial sites (14)

FacilityCityRegionStatus
Ludwigsburg Hospital, Department of Gynecology and Obstetrics Ludwigsburg Baden-Wurttemberg Recruiting
University Medical Center Tübingen, Department of Gynecology Tübingen Baden-Wurttemberg Recruiting
Hochtaunus-Clinics Bad Homburg, Department of Gynecology Bad Homburg Hesse Recruiting
University Medical Center Göttingen, Department of Gynecology and Obstetrics Göttingen Lower Saxony Recruiting
Hannover Medical School, Department of Gynecology and Obstetrics Hanover Lower Saxony Recruiting
Hospital Lüneburg, Department of Gynecology Lüneburg Lower Saxony Recruiting
Hospital Bielefeld - Center, Department of Gynecology Bielefeld North Rhine-Westphalia Recruiting
University Medical Center Düsseldorf, Department of Gynecology and Obstetrics Düsseldorf North Rhine-Westphalia Recruiting
Protestant Hospital Wesel, Gynecological Cancer Center Wesel North Rhine-Westphalia Recruiting
University Medical Center Mainz, Department of Obstetrics and Gynecology Mainz Rhineland-Palatinate Recruiting
University Hospital Schleswig-Holstein, Campus Kiel, Department of Gynecology and Obstetrics Kiel Schleswig-Holstein Recruiting
Vivantes Auguste-Viktoria-Hospital, Department of Gynecology Berlin Schöneberg State of Berlin Recruiting
Martin Luther Hospital Berlin, Department of Gynecology and Obstetrics Berlin Germany Recruiting
University Medical Center Hamburg-Eppendorf, Department of Gynecology Hamburg Germany Recruiting

More Hannover Medical School trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06489795 on ClinicalTrials.gov ↗ ← All trials in Germany