Status:
RECRUITING
German-funded Laparoscopic Approach to Cervical Cancer
Lead Sponsor:
Hannover Medical School
Collaborating Sponsors:
German Cancer Aid
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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-infe...
Detailed Description
Eligible patients will be randomly allocated to both treatment arms in a 1:1 ratio. Within an accrual period of 4 years, 378 patients will be included per arm (756 in total) across all sites. The Foll...
Eligibility Criteria
Inclusion
- Histologically confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix
- Patients with FIGO stage IA2, IB1, or IB2 disease (\<4 cm)
- 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.
- Performance status of ECOG 0-1
- Patient must be suitable candidates for surgery with preoperative MRI and available for assessment of serious adverse events up to one year post-surgery
- Patients who have signed an approved Informed Consent
- Patients with a prior malignancy only if \> 5 years previous with no evidence of disease
- Females, aged 18 years or older
Exclusion
- Any histology other than an adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma of the uterine cervix
- Tumor size of 4 cm and greater, estimated by either magnetic resonance imaging (MRI) or clinical examination
- FIGO stage IB3 - IV
- Patients with a history of pelvic or abdominal radiotherapy
- Patients with evidence of metastatic disease by conventional imaging studies, enlarged pelvic or aortic lymph nodes \> 2 cm, or histologically positive lymph nodes
- Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
- Patients unable to withstand prolonged lithotomy and steep Trendelenburg position
- Patient compliance and geographic proximity that do not allow adequate follow-up
- Women who are pregnant
- Patients with contraindications to surgery
- 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)
Key Trial Info
Start Date :
July 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2034
Estimated Enrollment :
756 Patients enrolled
Trial Details
Trial ID
NCT06489795
Start Date
July 17 2024
End Date
January 1 2034
Last Update
February 3 2025
Active Locations (14)
Enter a location and click search to find clinical trials sorted by distance.
1
Ludwigsburg Hospital, Department of Gynecology and Obstetrics
Ludwigsburg, Baden-Wurttemberg, Germany, 71640
2
University Medical Center Tübingen, Department of Gynecology
Tübingen, Baden-Wurttemberg, Germany, 72076
3
Hochtaunus-Clinics Bad Homburg, Department of Gynecology
Bad Homburg, Hesse, Germany, 61352
4
University Medical Center Göttingen, Department of Gynecology and Obstetrics
Göttingen, Lower Saxony, Germany, 37075