Minimally invasive surgery for early-stage cervical cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The G-LACC trial evaluates the effectiveness of minimally invasive radical hysterectomy compared to traditional abdominal radical hysterectomy in patients with early-stage cervical cancer. This multicenter, open-label, randomized trial will include 756 patients, who will be randomly assigned to either treatment arm. The primary outcome is disease-free survival, while secondary outcomes include overall survival, disease recurrence, quality of life, and complications. The follow-up period after surgery will last a minimum of five years to assess long-term outcomes.

Why it matters

Who can join: the full rules

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)

Where it's running

• Ludwigsburg Hospital, Department of Gynecology and Obstetrics
  Ludwigsburg, Baden-Wurttemberg, Germany Recruiting
• University Medical Center Tübingen, Department of Gynecology
  Tübingen, Baden-Wurttemberg, Germany Recruiting
• Hochtaunus-Clinics Bad Homburg, Department of Gynecology
  Bad Homburg, Hesse, Germany Recruiting
• University Medical Center Göttingen, Department of Gynecology and Obstetrics
  Göttingen, Lower Saxony, Germany Recruiting
• Hannover Medical School, Department of Gynecology and Obstetrics
  Hanover, Lower Saxony, Germany Recruiting
• Hospital Lüneburg, Department of Gynecology
  Lüneburg, Lower Saxony, Germany Recruiting

Study contacts

• Principal investigator: Peter Hillemanns, Prof. Dr. — Hannover Medical School, Department of Gynecology and Obstetrics
• Study coordinator: Peter Hillemanns, Prof. Dr.
• Email: frauenklinik@mh-hannover.de
• Phone: +49 (0) 511 532

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Cervical screening and care options for women living with HIV who test positive for high-risk HPV

  This study tests different ways to screen and manage high-risk HPV in women with HIV to see what might work best for them.

  Recruiting University of California, San Diego · Nairobi · NCT07925307

• Hydrogel spacer to protect the rectum during cervical cancer radiotherapy

  This study tests whether placing an absorbable hydrogel spacer between the cervix/vagina and rectum before definitive radiotherapy can reduce rectal radiation exposure for women with cervical cancer.

  Recruiting Tianjin Medical University Cancer Institute and Hospital · Tianjin, Tianjin Municipality · NCT07904182

• How cinema sessions during chemotherapy might help cervical cancer patients

  We’re testing if watching films during chemotherapy helps cervical cancer patients feel less anxious and improve quality of life.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Roma · NCT07902180

• One-Finger Technique to identify the left upper ureter during para-aortic lymphadenectomy

  This study tests a new surgical method to help surgeons find the left upper ureter during open para-aortic lymphadenectomy in women with gynecologic cancers.

  Recruiting Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Guangzhou, Guangdong · NCT07895212

• Radiotherapy for gynecologic cancer with up to 10 metastatic sites

  This registry follows adults with gynecologic cancer who have 1 to 10 active metastatic lesions and are treated with radiotherapy as part of routine care to see how such treatments work in real-world settings.

  Recruiting Affidea Nu-med Center of Oncological DIagnostics and Therapy · Zamość · NCT07883798

• Stellate ganglion block and dexmedetomidine for better sleep after gynecologic laparoscopy

  The study tests whether giving a preoperative stellate ganglion block plus intraoperative dexmedetomidine improves sleep after laparoscopic gynecologic surgery in women.

  Recruiting The Second People's Hospital of Huai'an · Huai'an, Jiangsu · NCT07860203

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.