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 sites740 target enrollmentJanuary 14, 2008

Overview

No summary available.

Registry

who.int

Start Date

January 14, 2008

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

Female

Sponsor

M.D Anderson Cancer Centre

•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;

•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.