Status:

RECRUITING

German-funded Laparoscopic Approach to Cervical Cancer

Lead Sponsor:

Hannover Medical School

Collaborating Sponsors:

German Cancer Aid

Conditions:

Cervical Cancer

Eligibility:

FEMALE

18+ years

Phase:

NA

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-infe...

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 Foll...

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)

Key Trial Info

Start Date :

July 17 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 1 2034

Estimated Enrollment :

756 Patients enrolled

Trial Details

Trial ID

NCT06489795

Start Date

July 17 2024

End Date

January 1 2034

Last Update

February 3 2025

Active Locations (14)

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Page 1 of 4 (14 locations)

1

Ludwigsburg Hospital, Department of Gynecology and Obstetrics

Ludwigsburg, Baden-Wurttemberg, Germany, 71640

2

University Medical Center Tübingen, Department of Gynecology

Tübingen, Baden-Wurttemberg, Germany, 72076

3

Hochtaunus-Clinics Bad Homburg, Department of Gynecology

Bad Homburg, Hesse, Germany, 61352

4

University Medical Center Göttingen, Department of Gynecology and Obstetrics

Göttingen, Lower Saxony, Germany, 37075