A Phase III Randomized Clinical Trial of Laparoscopic or Robotic RH using cancer cell spillage minimizing techniques vs Abdominal RH in Patients with Early-Stage Cervical Cancer

Asan Medical Center0 个研究点目标入组 452 人开始时间: 待定最近更新: 2023年8月21日

试验速览

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•1) Patients aged 20-80 years
•2) Histologically confirmed adenocarcinoma, squamous cell carcinoma, or adenosquamous cell carcinoma of the cervix
•3) Patients who qualify for 2018 FIGO IA2 or IB1-2
•4) Patients undergoing type II or III radical hysterectomy (Piver Classification)
•5) Patients with adequate bone marrow, kidney and liver function
•? WBC = 3,000/mm3
•? Platelets = 100,000/mm3
•? Creatinine = 2.0 mg/dL
•? Bilirubin = 1.5 x institutional upper limit normal
•? SGOT, SGPT, and ALP = 3 x institutional upper limit normal
•6) Performance status of ECOG 0-1
•7) Patients who voluntarily signed the research subject consent form

•1) Any histological type other than adenocarcinoma, squamous cell carcinoma or adenosquamous cell carcinoma of the cervix
•2) Tumor size greater than 4 cm on imaging examination
•3) FIGO stage II-IV
•4) Patients with a history of pelvic or abdominal radiation therapy
•5) Patients with evidence of metastatic disease on preoperative imaging, enlarged pelvic or aortic lymph nodes > 1.5 cm; or histologically positive lymph nodes
•6) If you are unable to determine whether to consent yourself
•7) Patients with serious underlying diseases or complications
•8) Women who are pregnant or lactating
•9) Neoadjuvant chemotherapy or preoperative radiation therapy
•10) Patients who have had cancer other than non-melanoma skin cancer, cervical intraepithelial tumor, and superficial cancer of the stomach and bladder within 5 years or have received cancer treatment

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