Comparing robot-assisted and open surgery for early stage cervical cancer
Robot-assisted Approach to Cervical Cancer
This study tests whether robot-assisted surgery is better than traditional open surgery for women with early stage cervical cancer in terms of recovery and preventing cancer from coming back.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT03719547 on ClinicalTrials.gov |
What this trial studies
The RACC trial aims to evaluate the oncologic outcomes, specifically recurrence-free survival, between robot-assisted radical hysterectomy and traditional open radical hysterectomy in patients with early stage cervical cancer. This study is significant as it explores the potential benefits of minimally invasive surgical techniques, which may lead to reduced morbidity and improved quality of life for patients. The trial includes patients with confirmed early stage cervical cancer who meet specific eligibility criteria, ensuring a focused approach to treatment evaluation. By utilizing advanced surgical methods, the study seeks to provide high-quality evidence regarding the effectiveness of robot-assisted surgery in this context.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 years or older with histologically confirmed early stage cervical cancer (stage IB or IIA1).
Not a fit: Patients with tumor sizes greater than 4 cm or those with advanced stages of cervical cancer (FIGO stage II-IV) will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and quality of life for patients with early stage cervical cancer.
How similar studies have performed: Previous studies have shown promising results with robot-assisted surgical techniques in gynecological oncology, suggesting potential benefits in terms of recovery and outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Stockholm
- Karolinska University Hospital — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Henrik Falconer, PhD — Karolinska University Hospital
- Study coordinator: Katja Wiklund
- Email: katja.wiklund@regionstockholm.se
- Phone: +46 8 123 725 84
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.