A Randomized Controlled Trial of Robotic versus Open Radical Hysterectomy for Cervical Cancer

Not Applicable

• Conditions: Neoplasms

• Registration Number: KCT0009284
• Lead Sponsor: The Catholic University of Korea, Seoul St. Mary's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 2 April 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 840

Inclusion Criteria

1) Patient must have histologically confirmed uterine cervical adenocarcinoma (usual/classic/NOS), squamous cell carcinoma, or adenosquamous carcinoma (includes glassy cell).
2) Patient must be FIGO Stage IA2, IBI, IB2 (2018 staging) uterine cervical cancer without evidence of definitive parametrial, vaginal, nodal or distant metastases on exam or imaging. Patients with tumor size less than or equal to 4 cm confirmed on MRI prior to randomization are eligible.
3) Patient must have uterine size <12 cm AND felt to be appropriate for vaginal delivery of specimen per investigator.
4) Patient must be suitable surgical candidate with preoperative assessments such as labs and EKG performed per institutional standard.
5) Patient must be age 18 years or older.
6) Patient must have ECOG performance status 0-1.
7) Patient must have signed an approved informed consent and authorization permitting the release of personal health information.

Exclusion Criteria

1) Patients with any uterine cervical cancer tumor histology other than those listed above, specifically excluding the following histologies: neuroendocrine, other adenocarcinoma (gastric type, endometrioid, clear cell, serous, signet ring, minimal deviation).
2) Patients with FIGO stage 1A1, IB3, II-IV (2018 staging).
3) Patient with inability to obtain MRI.
4) Patients with tumor size greater than 4cm on MRI confirmed prior to randomization are excluded.
Patients with definite evidence of vaginal/parametrial involvement on MRI are excluded; if MRI findings are not definitive, then clinical examination must also not reveal parametrial or vaginal extension.
5) Patients with evidence of metastatic disease (imaging or histologically positive lymph nodes).
6) Patients with a history of prior pelvic or abdominal radiotherapy.
7) Patients with a prior malignancy within < 5 years from enrollment with the exception of non- melanoma skin cancer.
8) Patients who are unable to withstand prolonged lithotomy or steep Trendelenberg.
9) Patient compliance and geographic proximity that do not allow adequate follow-up.
10) Patients with poorly controlled HIV with CD4 counts <500.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
disease-free survival

Secondary Outcome Measures

Name	Time	Method
Compare disease specific survival (DSS) and overall survival (OS) ;Compare patterns of recurrence;Compare intra- and immediate post-operative complications;Compare long-term morbidity;Compare the impact on patient reported outcomes (PROs);Compare patient-reported lower extremity lymphedema