Robot-assisted Approach to Cervical Cancer

Recruiting now · Not applicable

Conditions studied: Cervical Cancer

In brief

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.

Key facts

Study ID

NCT03719547

Run by

Karolinska Institutet

People needed

800

Starts

2019-05-28

Expected to finish

2027-12-31

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Karolinska University Hospital — Stockholm, Sweden (enrolling)

Full record on ClinicalTrials.gov

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