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Preservation of Ovarian Function Via LOT in Squamous Cell Carcinoma of the Cervix

Primary Purpose

Cervical Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laparoscopic ovarian transposition
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring Cervical Cancer, Squamous Cell, Laparoscopy, Ovarian Function

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Newly diagnosed Stages iB-iiiB squamous cell carcinoma of the cervix Exclusion Criteria: Evidence of ovarian involvement on MRI Evidence of uterine involvement on MRI Evidence of distant mets on MRI

Sites / Locations

  • University of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Laparoscopic Ovarian Transposition

Outcomes

Primary Outcome Measures

Menopause

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
November 13, 2019
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT00204997
Brief Title
Preservation of Ovarian Function Via LOT in Squamous Cell Carcinoma of the Cervix
Official Title
Preservation of Ovarian Function Via Laparoscopic Transposition in Patients With Locally Advanced Squamous Cell Carcinoma of the Cervix
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Terminated
Why Stopped
slow accrual
Study Start Date
September 2002 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the feasibility, safety and efficacy of laparoscopic ovarian transposition in women less than 40 years of age with locally advanced cervical squamous cell carcinoma

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
Cervical Cancer, Squamous Cell, Laparoscopy, Ovarian Function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Laparoscopic Ovarian Transposition
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic ovarian transposition
Intervention Description
Laparoscopic ovarian transposition
Primary Outcome Measure Information:
Title
Menopause
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Newly diagnosed Stages iB-iiiB squamous cell carcinoma of the cervix Exclusion Criteria: Evidence of ovarian involvement on MRI Evidence of uterine involvement on MRI Evidence of distant mets on MRI
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M Kushner, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Links:
URL
https://cancer.wisc.edu/
Description
University of Wisconsin Carbone Cancer Center

Learn more about this trial

Preservation of Ovarian Function Via LOT in Squamous Cell Carcinoma of the Cervix

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