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Clinical Trials in Sweden / NCT03719547
Recruiting Not applicable

Robot-assisted Approach to Cervical Cancer

NCT03719547 · tracked via the Priya Life Science Sweden tracker
Phase
Not applicable
Started
2019-05-28
Last updated
2026-08-07

Condition(s) studied

Cervical Cancer

Investigational drug(s) / intervention(s)

Abdominal radical hysterectomyRobot-assisted radical hysterectomySentinel lymph node biopsy

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)

Trial sites (1)

FacilityCityRegionStatus
Karolinska University Hospital Stockholm Sweden Recruiting

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Official registry record

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.

View NCT03719547 on ClinicalTrials.gov ↗ ← All trials in Sweden