German-funded Laparoscopic Approach to Cervical Cancer

A vizsgálat adatai

Ki végzi

Hannover Medical School

Azonosító

NCT06489795

A regiszteradat frissítve

2025. február 3.

Eredeti leírás

The G-LACC trial is a prospective, interventional, multicenter, open-label, randomized and controlled non-inferiority operative trial.A teljes eredeti leírásKevesebb

A Randomized Clinical Trial Comparing Laparoscopic or Robot-assisted Radical/Simple Hysterectomy Versus Abdominal Radical/Simple Hysterectomy in Patients With Early-stage Cervical Cancer

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.

Bevonási feltételek: 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.

Kizáró feltételek: Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator); Patients with contraindications to surgery; 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; 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); 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 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.

ClinicalTrials.gov NCT06489795