German-funded Laparoscopic Approach to Cervical Cancer

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.

Eligibility

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)

Conditions2

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