German-funded Laparoscopic Approach to Cervical Cancer
NCT Number: NCT06489795
Acronym: G-LACC
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cervical Cancer
Interventions: PROCEDURE: Laparoscopic or robot-assisted radical/simple hysterectomy|PROCEDURE: Abdominal radical/simple hysterectomy
Sponsor: Hannover Medical School
Collaborators: German Cancer Aid
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 756
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2034-01
Locations: Hannover Medical School, Department of Gynecology and Obstetrics, Hannover, Lower Saxony, 30625, Germany

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.

Primary Outcome Measures: 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., up to year 5
Secondary Outcome Measures: Overall survival, Overall survival (OS) is defined as the time from randomization to death from any cause., up to year 5|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., up to year 5 starting 6 months post-surgery|Health Related Quality of Life (HRQoL), 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), up to year 5|Health Related Quality of Life (HRQoL), Health Related Quality of Life (HRQoL) will be assessed by using the validated questionnaire EORTC QLQ Cervical Cancer Module (EORTC QLQ-CX24), up to year 5|Health Related Quality of Life (HRQoL), Health Related Quality of Life (HRQoL) will be assessed by using the validated questionnaire EuroQoL EQ-5D-3L, up to year 5|Health Related Quality of Life (HRQoL), Health Related Quality of Life (HRQoL) will be assessed by using the validated sexual activity questionnaires (SAQ)., up to year 5|Lymphatic side effects, Lymphatic side effects will be assessed by the investigator using Common Terminology Criteria for Adverse Events (CTCAE 3.0), up to year 5|Lymphatic side effects, Lymphatic side effects will be assessed by the patient using the Lymphoedema Quality-of-Life (LYMQOL) questionnaire., up to year 5|Complications and treatment-associated morbidity, Treatment-related intraoperative complications are recorded on the day of surgery according to Rosenthal's definition.

Treatment-related postoperative complications are recorded from the day of surgery until one year after surgery., up to one year after surgery|Serious adverse events, Serious adverse events (SAEs) will be captured from the day of surgery until one year post surgery. Treatment-related SAEs are documented as intra-/postoperative complications according to Outcome 5., up to one year after surgery|Health care costs, Cost-effectiveness will be determined as incremental cost-effectiveness ratios., up to year 5|Health care costs, Direct costs will be assessed via internal accounting and billing systems within the hospitals., up to year 5|Health care costs, Quality-adjusted life years (QALY) calculations will be used for a cost-utility analysis., up to year 5