๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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)
๐
What it tests
- Abdominal radical hysterectomy
- Robot-assisted radical hysterectomy
- Sentinel lymph node biopsy
Karolinska University Hospital
Stockholm, Sweden
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.