Robot-assisted Approach to Cervical Cancer

Summary

The purpose of the RACC trial is to compare the oncologic outcome defined as recurrence-free survival (RFS) between robot-assisted and open radical hysterectomy for the treatment of early stage cervical cancer.

Eligibility

Inclusion Criteria:

* Histologically confirmed primary adenocarcinoma, squamous cell carcinoma or adeno-squamous carcinoma of the uterine cervix;
* Patients with histologically confirmed stage IB (IB3 excluded) and IIA1, according to the latest revision of the FIGO staging manual
* Patients undergoing either a Type B or C radical hysterectomy (Querleu and Morrow classification)
* Patients with adequate bone marrow, renal and hepatic function
* ECOG Performance Status of 0, 1 or 2.
* Patient must be suitable candidates for surgery.
* Patients who have signed an approved Informed Consent
* Age 18 years or older

Exclusion Criteria:

* Any histology other than adenocarcinoma, squamous cell carcinoma or adeno-squamous carcinoma of the uterine cervix
* Tumor size greater than 4 cm
* FIGO stage II-IV (except IIA1)
* Patients with a history of pelvic or abdominal radiotherapy
* Patients who are pregnant
* Patients with contraindications to surgery
* Patients with evidence of metastatic disease by conventional imaging, enlarged pelvic or aortic lymph nodes \> 2cm; or histologically positive lymph nodes
* Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
* Patients unable to withstand prolonged lithotomy and steep Trendelenburg position
* Patients with secondary invasive neoplasm in the last 5 years (except non-melanoma skin cancer, breast cancer T1N0M0 grade 1 or 2 without any signs of recurrence or activity)

Conditions2

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