Robot-assisted Approach to Cervical Cancer

Who is this study for? Adult female patients with Uterine Cervical Squamous Cell Carcinoma, Adenocarcinoma, or Adenosquamous Carcinoma
Status: Recruiting
Location: See location...
Intervention Type: Procedure, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Sweden
Karolinska University Hospital
RECRUITING
Stockholm
Contact Information
Primary
Katja Wiklund
katja.wiklund@regionstockholm.se
+46 8 123 725 84
Time Frame
Start Date: 2019-05-28
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 800
Treatments
Experimental: Robot-assisted radical hysterectomy
Total radical hysterectomy with Sentinel lymph node biopsy followed by completion pelvic lymphadenectomy
Active_comparator: Abdominal radical hysterectomy
Total radical hysterectomy with Sentinel lymph node biopsy followed by completion pelvic lymphadenectomy
Related Therapeutic Areas
Sponsors
Leads: Karolinska Institutet

This content was sourced from clinicaltrials.gov