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New treatment option for Cervical Cancer
Official title German-funded Laparoscopic Approach to Cervical Cancer
ClinicalTrials.gov ID: NCT06489795
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join 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...
- 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...
You likely can't join 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...
- Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
See the full eligibility criteria
- 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...
- 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Ludwigsburg, Baden-Wurttemberg, Germany
- Tübingen, Baden-Wurttemberg, Germany
- Bad Homburg, Hesse, Germany
- Göttingen, Lower Saxony, Germany
- Hanover, Lower Saxony, Germany
- Lüneburg, Lower Saxony, Germany
- Bielefeld, North Rhine-Westphalia, Germany
- Düsseldorf, North Rhine-Westphalia, Germany
- Wesel, North Rhine-Westphalia, Germany
- Mainz, Rhineland-Palatinate, Germany
- Kiel, Schleswig-Holstein, Germany
- Berlin Schöneberg, State of Berlin, Germany
- Berlin, Germany
- Hamburg, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ludwigsburg, Baden-Wurttemberg, Germany; Tübingen, Baden-Wurttemberg, Germany; Bad Homburg, Hesse, Germany; Göttingen, Lower Saxony, Germany; Hanover, Lower Saxony, Germany; Lüneburg, Lower Saxony, Germany and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.