Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT03719547

Robot-assisted Approach to Cervical Cancer

Led by Karolinska Institutet · Updated on 2025-07-01

800

Participants Needed

1

Research Sites

448 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Robot-assisted Approach to Cervical Cancer

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Karolinska University Hospital

Stockholm, Sweden, 17176

Actively Recruiting

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Research Team

K

Katja Wiklund

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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