Minimally invasive surgery for early-stage cervical cancer
A Randomized Clinical Trial Comparing Laparoscopic or Robot-assisted Radical/Simple Hysterectomy Versus Abdominal Radical/Simple Hysterectomy in Patients With Early-stage Cervical Cancer
This study is testing if a less invasive surgery for early-stage cervical cancer can help patients live longer and have fewer complications compared to traditional surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 756 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Hannover Medical School Academic / other |
| Locations | 14 sites (Ludwigsburg, Baden-Wurttemberg and 13 other locations) |
| Trial ID | NCT06489795 on ClinicalTrials.gov |
What this trial studies
The G-LACC trial evaluates the effectiveness of minimally invasive radical hysterectomy compared to traditional abdominal radical hysterectomy in patients with early-stage cervical cancer. This multicenter, open-label, randomized trial will include 756 patients, who will be randomly assigned to either treatment arm. The primary outcome is disease-free survival, while secondary outcomes include overall survival, disease recurrence, quality of life, and complications. The follow-up period after surgery will last a minimum of five years to assess long-term outcomes.
Who should consider this trial
Good fit: Ideal candidates are women with early-stage cervical cancer (FIGO stage IA2, IB1, or IB2) who are suitable for radical or simple hysterectomy.
Not a fit: Patients with advanced cervical cancer or those not suitable for surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery times and quality of life for patients undergoing surgery for cervical cancer.
How similar studies have performed: Previous studies, such as the SHAPE trial, have shown positive results for minimally invasive approaches in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Ludwigsburg, Baden-Wurttemberg and 13 other locations
- Ludwigsburg Hospital, Department of Gynecology and Obstetrics — Ludwigsburg, Baden-Wurttemberg, Germany (Recruiting)
- University Medical Center Tübingen, Department of Gynecology — Tübingen, Baden-Wurttemberg, Germany (Recruiting)
- Hochtaunus-Clinics Bad Homburg, Department of Gynecology — Bad Homburg, Hesse, Germany (Recruiting)
- University Medical Center Göttingen, Department of Gynecology and Obstetrics — Göttingen, Lower Saxony, Germany (Recruiting)
- Hannover Medical School, Department of Gynecology and Obstetrics — Hanover, Lower Saxony, Germany (Recruiting)
- Hospital Lüneburg, Department of Gynecology — Lüneburg, Lower Saxony, Germany (Recruiting)
- Hospital Bielefeld - Center, Department of Gynecology — Bielefeld, North Rhine-Westphalia, Germany (Recruiting)
- University Medical Center Düsseldorf, Department of Gynecology and Obstetrics — Düsseldorf, North Rhine-Westphalia, Germany (Recruiting)
- Protestant Hospital Wesel, Gynecological Cancer Center — Wesel, North Rhine-Westphalia, Germany (Recruiting)
- University Medical Center Mainz, Department of Obstetrics and Gynecology — Mainz, Rhineland-Palatinate, Germany (Recruiting)
- University Hospital Schleswig-Holstein, Campus Kiel, Department of Gynecology and Obstetrics — Kiel, Schleswig-Holstein, Germany (Recruiting)
- Vivantes Auguste-Viktoria-Hospital, Department of Gynecology — Berlin Schöneberg, State of Berlin, Germany (Recruiting)
- Martin Luther Hospital Berlin, Department of Gynecology and Obstetrics — Berlin, Germany (Recruiting)
- University Medical Center Hamburg-Eppendorf, Department of Gynecology — Hamburg, Germany (Recruiting)
Study contacts
- Principal investigator: Peter Hillemanns, Prof. Dr. — Hannover Medical School, Department of Gynecology and Obstetrics
- Study coordinator: Peter Hillemanns, Prof. Dr.
- Email: frauenklinik@mh-hannover.de
- Phone: +49 (0) 511 532
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.