Robot-assisted Approach to Cervical Cancer
RACC
1 other identifier
interventional
800
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2018
CompletedFirst Posted
Study publicly available on registry
October 25, 2018
CompletedStudy Start
First participant enrolled
May 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
July 1, 2025
March 1, 2025
7.8 years
October 16, 2018
June 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrence-free survival
Time-interval between the date of randomisation and the date of recurrence or the date of death
60 months from surgery
Secondary Outcomes (6)
Overall survival
60 months from surgery
Intraoperative complications: number of participants with bowel injuries, urinary tract injuries, hemorrhage requiring vessel suture and/or transfusion, nerve injuries
Complications occurring during intervention (intraoperatively)
Post-operative complications: Number of participants requiring pharmacological treatment (CD II) OR surgical, endoscopic or radiological intervention (CD III) OR life-threatening complications requiring ICU-management (CD IV) OR death (CD V)
Postoperative complications are assessed at 30 days postoperatively and at 6 months postoperatively
Health-related quality of life (HRQoL) after surgery for early stage cervical cancer using European Organisation for Research and Treatment of Cancer Quality of Life Cancer Patients (EORTC-QLQ).
Before randomisation, 1 month post surgery, 6 months post surgery, 12 months post surgery, 24 months post surgery, 60 months post surgery
Sentinel lymph node biopsy in cervical cancer
Through study completion, an average of 5 years
- +1 more secondary outcomes
Study Arms (2)
Robot-assisted radical hysterectomy
EXPERIMENTALTotal radical hysterectomy with Sentinel lymph node biopsy followed by completion pelvic lymphadenectomy
Abdominal radical hysterectomy
ACTIVE COMPARATORTotal radical hysterectomy with Sentinel lymph node biopsy followed by completion pelvic lymphadenectomy
Interventions
Radical hysterectomy (type B or C according to the Querleu\&Morrow classification) with pelvic lymphadenectomy
Radical hysterectomy (type B or C according to the Querleu\&Morrow classification) with pelvic lymphadenectomy
Assessment of sentinel lymph nodes using either radiotracer or indocyanine green (ICG)
Eligibility Criteria
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Karolinska University Hospital
Stockholm, 17176, Sweden
Related Publications (1)
Falconer 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: 31203203DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Henrik Falconer, PhD
Karolinska University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of GYN Oncology
Study Record Dates
First Submitted
October 16, 2018
First Posted
October 25, 2018
Study Start
May 28, 2019
Primary Completion (Estimated)
March 30, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
July 1, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share