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Study Summary
No. 2007-0800:.......Cervix......Pedro Ramirez......Gynecologic Oncology
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Study Summary Title
Study Summary
Number:		2007-0800
Study Title:A Phase III Randomized Clinical Trial of Laparoscopic or Robotic Radical Hysterectomy versus Abdominal Radical Hysterectomy in Patients with Early Stage Cervical Cancer
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Physician New Patient Referral
Name:Pedro RamirezPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Gynecologic OncologyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-563-4569
Contact us about clinical trials
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General Information
Disease Group:CervixSupported By:Department of Gynecologic Oncology Surgery Research Program
Phase of Study:Phase IIIReturn
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.
Treatment
Agents:		Surgical ProcedureHome Care:None
Treatment Loc: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.
Description/
Intervention:		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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Study Objectives / Outcomes
Primary Objective:
To compare disease-free survival amongst patients who undergo a total laparoscopic or robotic radical hysterectomy (TLRH) verses those who undergo a total abdominal radical hysterectomy (TARH) for early stage cervical cancer.

Secondary objectives:
    1. Compare patterns of recurrence between arms.
    2. Compare treatment-associated morbidity within 6 months from surgery.
    3. Compare the cost effectiveness of TLRH or TRRH versus TARH
    4. Compare the impact on Quality of Life (QoL) between arms.
    5. Assess pelvic floor function
    6. Compare overall survival between arms
    7. Determine the feasibility of sentinel lymph node biopsy in this group of patients
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Study Status Information
Study Activation / Registration Date:
IRB Review and Approval Date:06/26/2008
Study Type:Other
Recruitment Status:Open
Projected Accrual:740
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Histologically confirmed, primary adenocarcinoma, squamous cell carcinoma or adenosquanous carcinoma of the uterine cervix.

2) Patients with FIGO stage IA1 (with lymph vascular space invasion), sstage IA2, or stage 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: WBC > 3,000 cells/mcl Platelets >100,000/mcl Creatinine <2.0 mg/dL (non-IDMS) Bilirubin <1.5 x normal and SGOT or SGPT <3 x normal

5) Performance status of ECOG 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.
Exclusion Criteria: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 LEEP cone biopsy within 4 wks of enrollment.
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Links
Registration Number: NCT00614211
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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