Trial Title:
German-funded Laparoscopic Approach to Cervical Cancer
NCT ID:
NCT06489795
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Conditions: Keywords:
cervical cancer FIGO stage IA2
cervical cancer FIGO stage IB1
cervical cancer FIGO stage IB2
laparoscopic or robot-assisted radical/simple hysterectomy
abdominal radical/simple hysterectomy
simple hysterectomy in the case of SHAPE criteria
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Interventional, multicenter, open-label, randomized, controlled non-inferiority trial
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Laparoscopic or robot-assisted radical/simple hysterectomy
Description:
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.
Arm group label:
Experimental intervention: Laparoscopic or robot-assisted radical/simple hysterectomy
Intervention type:
Procedure
Intervention name:
Abdominal radical/simple hysterectomy
Description:
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.
Arm group label:
Control intervention: Abdominal radical/simple hysterectomy
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.
Detailed 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Histologically confirmed primary adenocarcinoma, squamous cell carcinoma or
adenosquamous 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 (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.
4. Performance status of ECOG 0-1
5. Patient must be suitable candidates for surgery with preoperative MRI and available
for 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 of
disease
8. Females, aged 18 years or older
Exclusion Criteria:
1. Any histology other than an adenocarcinoma, squamous cell carcinoma, or
adenosquamous 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 the
discretion 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-melanoma
skin cancer, breast cancer T1 N0 M0 grade 1 or 2 without any signs of recurrence or
activity)
Gender:
Female
Gender based:
Yes
Gender description:
Female 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
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hochtaunus-Kliniken Bad Homburg, Department of Gynecology
Address:
City:
Bad Homburg vor der Höhe
Zip:
61352
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Dominik Denschlag, Prof. Dr.
Phone:
+49 6172 14
Phone ext:
2580
Email:
sekretariat-frauenklinik@hochtaunus-kliniken.de
Facility:
Name:
Hannover Medical School, Department of Gynecology and Obstetrics
Address:
City:
Hannover
Zip:
30625
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Peter Hillemanns, Prof. Dr.
Phone:
+49 511 532
Phone ext:
6144
Email:
frauenklinik@mh-hannover.de
Contact backup:
Last name:
Hermann Hertel, Prof. Dr.
Phone:
+49 511 532
Phone ext:
9760
Email:
frauenklinik@mh-hannover.de
Facility:
Name:
Klinikum Lüneburg, Department of Gynecology
Address:
City:
Lüneburg
Zip:
21339
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Peter Dall, Prof. Dr.
Phone:
+49 4131 77
Phone ext:
2231
Email:
frauenklinik@klinikum-lueneburg.de
Facility:
Name:
Klinikum Bielefeld - Mitte, Department of Gynecology
Address:
City:
Bielefeld
Zip:
33604
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Werner Bader, Prof. Dr.
Phone:
+49 521 581
Phone ext:
3271
Email:
frauenklinik@klinikumbielefeld.de
Start date:
July 17, 2024
Completion date:
January 2034
Lead sponsor:
Agency:
Hannover Medical School
Agency class:
Other
Collaborator:
Agency:
German Cancer Aid
Agency class:
Other
Source:
Hannover Medical School
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06489795
