Status:
COMPLETED
Laparoscopic Approach to Cervical Cancer
Lead Sponsor:
Queensland Centre for Gynaecological Cancer
Collaborating Sponsors:
M.D. Anderson Cancer Center
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 hys...
Detailed Description
Primary Objective: To compare disease-free survival amongst patients who undergo a total laparoscopic (TLRH) or robotic radical hysterectomy (TRRH) verses those who undergo a total abdominal radical ...
Eligibility Criteria
Inclusion
- Histologically confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix;
- Patients with Histologically confirmed stage IA1 (with lymph vascular invasion), stage IA2, or stage IB1 disease
- Patients undergoing either a Type II or III radical hysterectomy (Piver Classification)
- Patients with adequate bone marrow, renal and hepatic function:
- ECOG Performance Status of 0 or 1.
- Patient must be suitable candidates for surgery.
- Patients who have signed an approved Informed Consent
- Patients with a prior malignancy allowed if \> 5 years ago with no current evidence of disease
- Females, aged 18 years or older
- Negative serum pregnancy test within \<30 days of surgery in pre-menopausal women and women \< 2 years after the onset of menopause
Exclusion
- Any histology other than adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix;
- Tumor size greater than 4 cm;
- FIGO stage II-IV;
- Patients with a history of pelvic or abdominal radiotherapy;
- Patients who are pregnant;
- Patients with contraindications to surgery;
- Patients with evidence of metastatic disease by conventional imaging studies, enlarged pelvic or aortic lymph nodes \> 2cm; or histologically positive lymph nodes
- Unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);
- Patients unable to withstand prolonged lithotomy and steep Trendelenburg position
- Patient compliance and geographic proximity that do not allow adequate follow-up
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
636 Patients enrolled
Trial Details
Trial ID
NCT00614211
Start Date
January 1 2008
End Date
March 1 2022
Last Update
April 18 2023
Active Locations (33)
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1
Greater Baltimore Medical Centre
Baltimore, Maryland, United States, 21204
2
Women's Cancer Centre Nevada
Las Vegas, Nevada, United States, 89169
3
St Luke's - Roosevelt Hospital Center
New York, New York, United States, 10019
4
Peggy and Charles Stephenson Oklahoma Cancer Center
Oklahoma City, Oklahoma, United States, 73104