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Robot-assisted Approach to Cervical Cancer

RecruitingNAAges 18 Years - anyFemaleKarolinska Institutet
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In 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.

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๐Ÿ“‹ 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)
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What it tests

  • Abdominal radical hysterectomy
  • Robot-assisted radical hysterectomy
  • Sentinel lymph node biopsy
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Where

1 site
Karolinska University Hospital
Stockholm, Sweden
๐Ÿค 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.
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