CLINICAL TRIAL SUMMARY

MDACC Study No:2007-0800 (clinicaltrials.gov NCT No: NCT00614211)
Title:A Phase III Randomized Clinical Trial of Laparoscopic or Robotic Radical Hysterectomy versus Abdominal Radical Hysterectomy in Patients with Early Stage Cervical Cancer
Principal Investigator:Pedro Ramirez
Treatment Agent:Surgical Procedure
Study Status:Open
Study Description:The goal of this clinical research study is to compare the long-term outcomes
of different surgical methods for the treatment of cervical cancer. The
long-term outcome of a total abdominal radical hysterectomy (TARH) will be
compared against laparoscopy. In this study, the laparoscopy will be done with
or without robotic technology. Researchers want to learn how long patients may
stay cancer-free after these types of surgery.

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Disease Group:Cervix
Phase of Study:Phase III
Treatment Agents:Surgical Procedure
Treatment Location:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated Length of Stay in Houston:One inpatient period for Surgical Treatment requiring approximately 3-5 days
hospitalization.
Supported By:Covidien
Department of Gynecologic Oncology Surgery Research Program
Return Visit:One pre-op visit;1 inpatient visit for surgery & recovery; post-op visits at 1
week, 4-6 weeks, and 3 months after surgery; follow-up visits every 3 months
for the first 2 years and every 6 months until year 4.5 post surgery.
Home Care:None


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Physician Name:Pedro Ramirez
Dept:Gynecologic Oncology
For Clinical Trial Enrollment:713-563-4569
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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