German-funded Laparoscopic Approach to Cervical Cancer

Last updated: January 31, 2025
Sponsor: Hannover Medical School
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vaginal Cancer

Uterine Disorders

Pelvic Cancer

Treatment

Abdominal radical/simple hysterectomy

Laparoscopic or robot-assisted radical/simple hysterectomy

Clinical Study ID

NCT06489795
G-LACC
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Histologically confirmed primary adenocarcinoma, squamous cell carcinoma oradenosquamous carcinoma of the uterine cervix

  2. Patients with FIGO stage IA2, IB1, or IB2 disease (<4 cm)

  3. Patients undergoing radical hysterectomy according either to Type II or III (PiverClassification) or to Type B or C (Querleu and Morrow classification) OR Simple hysterectomy can be considered for patients with low-risk early-stagecervical cancer (SHAPE criteria: tumor < 2cm, < 10 mm depth of stromal invasion (LEEP/cone). Simple hysterectomy has to be performed as extrafascial hysterectomyand the preparation of a max. 5mm vaginal cuff is required to ensure negativemargins.

  4. Performance status of ECOG 0-1

  5. Patient must be suitable candidates for surgery with preoperative MRI and availablefor assessment of serious adverse events up to one year post-surgery

  6. Patients who have signed an approved Informed Consent

  7. Patients with a prior malignancy only if > 5 years previous with no evidence ofdisease

  8. Females, aged 18 years or older

Exclusion

Exclusion Criteria:

  1. Any histology other than an adenocarcinoma, squamous cell carcinoma, oradenosquamous carcinoma of the uterine cervix

  2. Tumor size of 4 cm and greater, estimated by either magnetic resonance imaging (MRI)or clinical examination

  3. FIGO stage IB3 - IV

  4. Patients with a history of pelvic or abdominal radiotherapy

  5. Patients with evidence of metastatic disease by conventional imaging studies,enlarged pelvic or aortic lymph nodes > 2 cm, or histologically positive lymph nodes

  6. Serious concomitant systemic disorders incompatible with the study (at thediscretion of the investigator)

  7. Patients unable to withstand prolonged lithotomy and steep Trendelenburg position

  8. Patient compliance and geographic proximity that do not allow adequate follow-up

  9. Women who are pregnant

  10. Patients with contraindications to surgery

  11. Patients with secondary invasive neoplasm in the last 5 years (except non-melanomaskin cancer, breast cancer T1 N0 M0 grade 1 or 2 without any signs of recurrence oractivity)

Study Design

Total Participants: 756
Treatment Group(s): 2
Primary Treatment: Abdominal radical/simple hysterectomy
Phase:
Study Start date:
July 17, 2024
Estimated Completion Date:
January 31, 2034

Study Description

Eligible patients will be randomly allocated to both treatment arms in a 1:1 ratio. Within an accrual period of 4 years, 378 patients will be included per arm (756 in total) across all sites. The Follow-up period after surgery will take a minimum of 5 years.

In the standard arm, radical hysterectomy is performed as per standard technique abdominal radical hysterectomy (Piver type 2 or 3 or Querleu & Morrow Type B or C) with salpingectomy +/- oophorectomy. Ovaries may be removed or preserved +/- transposition. Surgery includes pelvic lymph node dissection or optional sentinel lymph node biopsy (SNB) according to current guidelines in both arms.

In the experimental arm, radical hysterectomy is performed as per standard conventional 2D/3D laparoscopic or robotic assisted technique (Querleu & Morrow Type B or C) with salpingectomy +/- oophorectomy. Ovaries may be removed or preserved +/- transposition. The following protective measures are mandatory for the minimally invasive arm: LEEP/conization prior to randomization or vaginal closure prior to colpotomy. Transcervical manipulators are not permitted. Use of uterus manipulators/ cervical adapter (without transcervical device) is allowed only after LEEP/conization. Meticulous dissection of pelvic (sentinel) lymph nodes including use of endobags and avoiding the dissemination of cancer cells will be implemented (tumor hygiene).

Due to the positive results of the SHAPE trial published at Plante et al. NEJM 2024, in both arms simple hysterectomy can be considered for patients with low-risk early-stage cervical cancer (SHAPE criteria: tumor < 2 cm, < 10 mm depth of stromal invasion (LEEP/cone) BUT has to be determined BEFORE randomization. Simple hysterectomy has to be performed as extrafascial hysterectomy and the preparation of a max. 5 mm vaginal cuff is required to ensure negative margins. Surgery can be performed including removal of the sentinel lymph nodes following the concept of sentinel lymph node biopsy (SNB) and according to the current guidelines.

Connect with a study center

  • Ludwigsburg Hospital, Department of Gynecology and Obstetrics

    Ludwigsburg, Baden-Württemberg 71640
    Germany

    Active - Recruiting

  • University Medical Center Tübingen, Department of Gynecology

    Tübingen, Baden-Württemberg 72076
    Germany

    Active - Recruiting

  • Vivantes Auguste-Viktoria-Hospital, Department of Gynecology

    Berlin Schöneberg, Berlin 12157
    Germany

    Active - Recruiting

  • Hochtaunus-Clinics Bad Homburg, Department of Gynecology

    Bad Homburg vor der Höhe, Hesse 61352
    Germany

    Active - Recruiting

  • Hochtaunus-Kliniken Bad Homburg, Department of Gynecology

    Bad Homburg vor der Höhe, Hesse 61352
    Germany

    Active - Recruiting

  • University Medical Center Göttingen, Department of Gynecology and Obstetrics

    Göttingen, Lower Saxony 37075
    Germany

    Active - Recruiting

  • Hannover Medical School, Department of Gynecology and Obstetrics

    Hannover, Lower Saxony 30625
    Germany

    Active - Recruiting

  • Hospital Lüneburg, Department of Gynecology

    Lüneburg, Lower Saxony 21339
    Germany

    Active - Recruiting

  • Klinikum Lüneburg, Department of Gynecology

    Lüneburg, Lower Saxony 21339
    Germany

    Active - Recruiting

  • Hospital Bielefeld - Center, Department of Gynecology

    Bielefeld, North Rhine-Westphalia 33604
    Germany

    Active - Recruiting

  • Klinikum Bielefeld - Mitte, Department of Gynecology

    Bielefeld, North Rhine-Westphalia 33604
    Germany

    Active - Recruiting

  • University Medical Center Düsseldorf, Department of Gynecology and Obstetrics

    Düsseldorf, North Rhine-Westphalia 40225
    Germany

    Active - Recruiting

  • Protestant Hospital Wesel, Gynecological Cancer Center

    Wesel, North Rhine-Westphalia 46485
    Germany

    Active - Recruiting

  • University Medical Center Mainz, Department of Obstetrics and Gynecology

    Mainz, Rhineland Palatinate 55131
    Germany

    Active - Recruiting

  • University Hospital Schleswig-Holstein, Campus Kiel, Department of Gynecology and Obstetrics

    Kiel, Schleswig-Holstein 24105
    Germany

    Active - Recruiting

  • Martin Luther Hospital Berlin, Department of Gynecology and Obstetrics

    Berlin, 14193
    Germany

    Active - Recruiting

  • University Medical Center Hamburg-Eppendorf, Department of Gynecology

    Hamburg, 20246
    Germany

    Active - Recruiting

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