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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Laparoscopic or robot-assisted radical/simple hysterectomy
Procedure/SurgeryIn 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
Procedure/SurgeryIn 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.
Treatment groups
756 Participants
are divided into 2 treatment groupsGroup A: Experimental intervention: Laparoscopic or robot-assisted radical/simple hysterectomyExperimental treatment 1 intervention
Group B: Control intervention: Abdominal radical/simple hysterectomyOther 1 intervention
Trial outcomes
Primary outcomes
1
Disease-free survival
Disease-free survival (DFS) is defined as the time from randomization to disease recurrence or death from any course (whichever occurs first). The date of disease recurrence is defined as the date of biopsy.
Time frame
up to year 5Secondary outcomes
1
Overall survival
Overall survival (OS) is defined as the time from randomization to death from any cause.
Time frame
up to year 52
Disease recurrence
The date of recurrence of disease is defined as the date of biopsy. A suspicion of disease recurrence (clinical or by imaging) should be verified by histopathological assessment. Disease recurrence will be assessed and recorded at each follow-up visit starting 6 months post-surgery.
Time frame
up to year 5 starting 6 months post-surgery3
Health Related Quality of Life (HRQoL): Core questionnaire
Health Related Quality of Life (HRQoL) will be assessed by using the validated questionnaire European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-30)
Time frame
up to year 54
Health Related Quality of Life (HRQoL): Cervical cancer questionnaire
Health Related Quality of Life (HRQoL) will be assessed by using the validated questionnaire EORTC QLQ Cervical Cancer Module (EORTC QLQ-CX24)
Time frame
up to year 5Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hannover Medical School
Lead sponsor
German Cancer Aid
Collaborator
Source ClinicalTrials.gov