A Phase III Randomized Clinical Trial of Laparoscopic or Robotic Radical Hysterectomy versus Abdominal Radical Hysterectomy in Patients with Early Stage Cervical Cancer

M.D Anderson Cancer Centre0 个研究点目标入组 740 人开始时间: 2008年1月14日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•1. Histologically confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix;
•2. Patients with International Federation of Gynecology and Obstetrics (FIGO) stage IA1 (with lymph vascular space invasion), IA2, or IB1 disease;
•3. Patients undergoing either a Type II or III radical hysterectomy (Piver Classification)
•4. Patients with adequate bone marrow, renal and hepatic function:
•4.1 White Blood Cells (WBC) > 3,000 cells/mcl
•4.2 Platelets >100,000/mcl
•4.3 Creatinine <2.0 mg/dL (Non-Isotope dilution mass spectrometry (non – IDMS))
•4.4 Bilirubin <1.5 x normal and Serum Glutamic Oxaloacetic Transaminase (SGOT) or Serum Glutamic Pyruvic Transaminase (SGPT) <3 x normal
•5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
•6. Patient must be suitable candidates for surgery;
•7. Patients who have signed an approved Informed Consent;
•8. Patients with a prior malignancy allowed if > 5 years previous with no current evidence of disease;
•9. Females, aged 18 years or older.
•10. Negative serum pregnancy test within 30 days of surgery in pre-menopausal women and women < 2 years after the onset of menopause

•1. Any histological type other than adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix;
•2. Tumor size greater than 4 cm;
•3. FIGO stage II-IV;
•4. Patients with a history of pelvic or abdominal radiotherapy;
•5. Patients who are pregnant;
•6. Patients with contraindications to surgery;
•7. Patients with evidence of metastatic disease by conventional imaging studies, enlarged pelvic or aortic lymph nodes > 2cm; or histologically positive lymph nodes 8. Unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);
•9. Patients unable to withstand prolonged lithotomy and steep Trendelenburg position
•10. Patient compliance and geographic proximity that do not allow adequate follow-up.
•11. Patients who agree to intra-operative lymphatic mapping (IOLM) must not have: - Known allergies to triphenylmethane compounds. - History of retroperitoneal surgery. - History of pelvic irradiation. - Cold knife or loop electrosurgical excision procedure (LEEP) cone biopsy within 4 wks of enrollment.

发起方

M.D Anderson Cancer Centre