Ignite Creation Date:
2024-07-17 @ 10:41 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06489795
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-23
Brief Title:
German-funded Laparoscopic Approach to Cervical Cancer
Sponsor:
Hannover Medical School
Organization:
Hannover Medical School
Study Overview
Official Title:
A Randomized Clinical Trial Comparing Laparoscopic or Robot-assisted RadicalSimple Hysterectomy Versus Abdominal RadicalSimple Hysterectomy in Patients With Early-stage Cervical Cancer
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
G-LACC
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
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 11 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 2D3D 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 LEEPconization 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 LEEPconization 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 LEEPcone 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
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 2D3D 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 LEEPconization 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 LEEPconization 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 LEEPcone 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None