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German-funded Laparoscopic Approach to Cervical Cancer

Study acronym: G-LACC
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Study sites: 4 to 14v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 4
    • Start date changed from estimate of Jul 2024 to Jul 17, 2024
    • Secondary endpoints revised (13)
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06489795
Lead Sponsor Hannover Medical School
Collaborators: German Cancer Aid
Conditions
(from sponsor)		 Cervical Cancer
Related terms Uterine Cervical Neoplasms
Enrollment 756 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov