RecruitingNot ApplicableNCT03719547
Robot-assisted Approach to Cervical Cancer
Sponsor
Karolinska Institutet
Enrollment
800 participants
Start Date
May 28, 2019
Study Type
INTERVENTIONAL
Conditions
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: FEMALEMin Age: 18 Years
Inclusion Criteria8
- 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 Criteria10
- 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)
Interventions
PROCEDUREAbdominal radical hysterectomy
Radical hysterectomy (type B or C according to the Querleu\&Morrow classification) with pelvic lymphadenectomy
PROCEDURERobot-assisted radical hysterectomy
Radical hysterectomy (type B or C according to the Querleu\&Morrow classification) with pelvic lymphadenectomy
DIAGNOSTIC_TESTSentinel lymph node biopsy
Assessment of sentinel lymph nodes using either radiotracer or indocyanine green (ICG)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03719547
Related Trials
ESPERANZA: External Control Arm Study for T-DXd for Patients With HER2 IHC3+ Solid Tumors
NCT0697316127 locations
GI-101/GI-101A as a Single Agent or in Combination With Pembrolizumab or Lenvatinib in Advanced Solid Tumors
NCT049774538 locations
A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (MK-2870-020/TroFuse-020/Gog-3101/ENGOT-cx20)
NCT06459180239 locations
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
NCT0721670360 locations
Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer
NCT0695266078 locations