German-funded Laparoscopic Approach to Cervical Cancer
ConditionCervical Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHannover Medical School
About this trial
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 criteria
Qualifiers
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)
Performance status of ECOG 0-1
Disqualifiers
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
Trial design
Treatments tested in this trial
- Laparoscopic or robot-assisted radical/simple hysterectomy
- Abdominal radical/simple hysterectomy
Treatment groups
756 Participants
are divided into 2 treatment groupsSponsors and collaborators
Hannover Medical School
Lead sponsor
German Cancer Aid
Collaborator
Source ClinicalTrials.gov