Abdominal radical hysterectomy: Radical hysterectomy (type B or C according to the Querleu\&Morrow classification) with pelvic lymphadenectomy
Robot-assisted radical hysterectomy: Radical hysterectomy (type B or C according to the Querleu\&Morrow classification) with pelvic lymphadenectomy
Sentinel lymph node biopsy: Assessment of sentinel lymph nodes using either radiotracer or indocyanine green (ICG)
Study 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
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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)
Primary outcome measure(s)
Recurrence-free survival — 60 months from surgery Time-interval between the date of randomisation and the date of recurrence or the date of death
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.