Clinical trial · Interventional
Robot-assisted Approach to Cervical Cancer
NCT03719547CI-TRIAL-00121108RACCrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abdominal radical hysterectomy | Procedure | — | UNRESOLVED |
| Robot-assisted radical hysterectomy | Procedure | — | UNRESOLVED |
| Sentinel lymph node biopsy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Robot-assisted radical hysterectomy
- description
- Total radical hysterectomy with Sentinel lymph node biopsy followed by completion pelvic lymphadenectomy
- interventionNames
- Procedure: Robot-assisted radical hysterectomy
- Diagnostic Test: Sentinel lymph node biopsy
- type
- ACTIVE_COMPARATOR
- label
- Abdominal radical hysterectomy
- description
- Total radical hysterectomy with Sentinel lymph node biopsy followed by completion pelvic lymphadenectomy
- interventionNames
- Procedure: Abdominal radical hysterectomy
- Diagnostic Test: Sentinel lymph node biopsy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDFalconer H, Palsdottir K, Stalberg K, Dahm-Kahler P, Ottander U, Lundin ES, Wijk L, Kimmig R, Jensen PT, Zahl Eriksson AG, Maenpaa J, Persson J, Salehi S. Robot-assisted approach to cervical cancer (RACC): an international multi-center, open-label randomized controlled trial. Int J Gynecol Cancer. 2019 Jul;29(6):1072-1076. doi: 10.1136/ijgc-2019-000558. Epub 2019 Jun 14. PMID 31203203