German-funded Laparoscopic Approach to Cervical Cancer

Launched by HANNOVER MEDICAL SCHOOL · Jul 4, 2024

Keywords

ClinConnect Summary

The G-LACC trial is a study looking at two different types of surgery for women with early-stage cervical cancer. Specifically, it compares a less invasive surgery called minimally invasive radical hysterectomy to the more traditional abdominal radical hysterectomy. The main focus of this trial is to see if the minimally invasive approach is just as effective as the abdominal surgery in keeping patients free from cancer after treatment. Researchers will also look at other important factors, like overall survival rates, recurrence of cancer, quality of life, and any complications that may arise during or after the surgery.

To participate in this trial, women must be at least 18 years old and have a confirmed diagnosis of certain types of cervical cancer that are early-stage and small in size. They should also be healthy enough for surgery and willing to follow up for a year after the procedure. Participants will receive comprehensive care and monitoring throughout the study. If you meet the eligibility criteria and decide to join, you'll be contributing to important research that could help improve treatment options for future patients with cervical cancer.

Gender

FEMALE

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)