NCT06489795

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
756

participants targeted

Target at P75+ for not_applicable

Timeline
92mo left

Started Jul 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

14 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Jul 2024Jan 2034

First Submitted

Initial submission to the registry

June 23, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 8, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

July 17, 2024

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2033

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2034

Last Updated

February 3, 2025

Status Verified

January 1, 2025

Enrollment Period

9 years

First QC Date

June 23, 2024

Last Update Submit

January 31, 2025

Conditions

Cervical Cancer

Keywords

cervical cancer FIGO stage IA2cervical cancer FIGO stage IB1cervical cancer FIGO stage IB2laparoscopic or robot-assisted radical/simple hysterectomyabdominal radical/simple hysterectomysimple hysterectomy in the case of SHAPE criteria

Outcome Measures

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.

    up to year 5

Secondary Outcomes (13)

  • Overall survival

    up to year 5

  • Disease recurrence

    up to year 5 starting 6 months post-surgery

  • Health Related Quality of Life (HRQoL): Core questionnaire

    up to year 5

  • Health Related Quality of Life (HRQoL): Cervical cancer questionnaire

    up to year 5

  • Health Related Quality of Life (HRQoL): General health status

    up to year 5

  • +8 more secondary outcomes

Study Arms (2)

Experimental intervention: Laparoscopic or robot-assisted radical/simple hysterectomy

EXPERIMENTAL

In the experimental arm, patients with early-stage cervical cancer will be treated by using laparoscopic or robot-assisted radical/simple hysterectomy.

Procedure: Laparoscopic or robot-assisted radical/simple hysterectomy

Control intervention: Abdominal radical/simple hysterectomy

OTHER

In the control arm, abdominal radical/simple hysterectomy (ARH) will be used as standard therapy.

Procedure: Abdominal radical/simple hysterectomy

Interventions

Laparoscopic or robot-assisted radical/simple hysterectomyPROCEDURE

In 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.

Experimental intervention: Laparoscopic or robot-assisted radical/simple hysterectomy
Abdominal radical/simple hysterectomyPROCEDURE

In 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.

Control intervention: Abdominal radical/simple hysterectomy

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale patients with operable early stage cervical cancer: International Federation of Gynecology and Obstetrics (FIGO) stage IA2 (lymph vascular invasion), IB1, or IB2 and a histologic subtype of squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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

You may not qualify if:

  • 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
  • Patients with evidence of metastatic disease by conventional imaging studies, enlarged pelvic or aortic lymph nodes \> 2 cm, or histologically positive lymph nodes
  • Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
  • 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
  • Patients with contraindications to surgery
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Ludwigsburg Hospital, Department of Gynecology and Obstetrics

Ludwigsburg, Baden-Wurttemberg, 71640, Germany

RECRUITING

University Medical Center Tübingen, Department of Gynecology

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

Hochtaunus-Clinics Bad Homburg, Department of Gynecology

Bad Homburg, Hesse, 61352, Germany

RECRUITING

University Medical Center Göttingen, Department of Gynecology and Obstetrics

Göttingen, Lower Saxony, 37075, Germany

RECRUITING

Hannover Medical School, Department of Gynecology and Obstetrics

Hanover, Lower Saxony, 30625, Germany

RECRUITING

Hospital Lüneburg, Department of Gynecology

Lüneburg, Lower Saxony, 21339, Germany

RECRUITING

Hospital Bielefeld - Center, Department of Gynecology

Bielefeld, North Rhine-Westphalia, 33604, Germany

RECRUITING

University Medical Center Düsseldorf, Department of Gynecology and Obstetrics

Düsseldorf, North Rhine-Westphalia, 40225, Germany

RECRUITING

Protestant Hospital Wesel, Gynecological Cancer Center

Wesel, North Rhine-Westphalia, 46485, Germany

RECRUITING

University Medical Center Mainz, Department of Obstetrics and Gynecology

Mainz, Rhineland-Palatinate, 55131, Germany

RECRUITING

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

Kiel, Schleswig-Holstein, 24105, Germany

RECRUITING

Vivantes Auguste-Viktoria-Hospital, Department of Gynecology

Berlin Schöneberg, State of Berlin, 12157, Germany

RECRUITING

Martin Luther Hospital Berlin, Department of Gynecology and Obstetrics

Berlin, 14193, Germany

RECRUITING

University Medical Center Hamburg-Eppendorf, Department of Gynecology

Hamburg, 20246, Germany

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Peter Hillemanns, Prof. Dr.

    Hannover Medical School, Department of Gynecology and Obstetrics

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Hillemanns, Prof. Dr.

CONTACT

+49 (0) 511 532frauenklinik@mh-hannover.de

Oliver Papp

CONTACT

+49 (0) 176 1532g-lacc.zks@mh-hannover.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Interventional, multicenter, open-label, randomized, controlled non-inferiority trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med., Director Department of Gynecology and Obstetrics

Study Record Dates

First Submitted

June 23, 2024

First Posted

July 8, 2024

Study Start

July 17, 2024

Primary Completion (Estimated)

July 1, 2033

Study Completion (Estimated)

January 1, 2034

Last Updated

February 3, 2025

Record last verified: 2025-01

Locations

DE(14)