German-funded Laparoscopic Approach to Cervical Cancer

Prior treatment

• Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
• Patients with contraindications to surgery

Other illness

• 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
• 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)

Other

• 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 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

• 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 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.
• 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