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Conservative Surgery for Women With Low-Risk, Early Stage Cervical Cancer
This clinical trial studies conservative surgery in treating patients with low-risk stage IA2 or IB1 cervical cancer. Conservative surgery is a less invasive type of surgery for early stage cervical cancer and may have fewer side effects and improve recovery.
PRIMARY OBJECTIVE: I. To evaluate the safety and feasibility of performing conservative surgery in women with stage IA2 or IB1 carcinoma of the cervix with favorable pathologic features. SECONDARY OBJECTIVES: I. To estimate the cervix cancer recurrence rate at 2 years in women treated with conservative surgery for stage IA2 or IB1 carcinoma of the cervix with favorable pathologic features. II. To compare pelvic lymph node involvement in patients undergoing conservative surgery with historical data from matched patients treated with radical hysterectomy. III. To estimate the sensitivity of sentinel lymph node biopsy in the determination of pelvic lymph node metastases in this group of patients. IV. To compare the treatment-associated morbidity in patients undergoing conservative surgery with historical data from matched patients treated with radical hysterectomy. V. To assess quality of life factors, sexual functioning, symptoms and satisfaction with healthcare decisions in this group of patients. OUTLINE: Patients undergo a complete lymphatic mapping with sentinel lymph node biopsy and/or pelvic lymph node dissection. If future fertility is no longer desired, patients also undergo hysterectomy with or without bilateral salpingo-oophorectomy. After completion of study treatment, patients are followed up every 3 months for 2 years and then yearly for 3 years.
Age
All ages
Sex
FEMALE
Healthy Volunteers
No
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
MD Anderson Cancer Center at Cooper-Voorhees
Voorhees Township, New Jersey, United States
Northwell Health Imbert Cancer Center
Bay Shore, New York, United States
Lyndon Baines Johnson General Hospital
Houston, Texas, United States
M D Anderson Cancer Center
Houston, Texas, United States
The Woman's Hospital of Texas
Houston, Texas, United States
MD Anderson in Katy
Houston, Texas, United States
MD Anderson League City
Nassau Bay, Texas, United States
MD Anderson in Sugar Land
Sugar Land, Texas, United States
Start Date
April 15, 2010
Primary Completion Date
December 31, 2024
Completion Date
December 5, 2025
Last Updated
January 7, 2026
137
ACTUAL participants
Lymph Node Mapping
PROCEDURE
Quality-of-Life Assessment
OTHER
Salpingo-Oophorectomy
PROCEDURE
Sentinel Lymph Node Biopsy
PROCEDURE
Therapeutic Conventional Surgery
PROCEDURE
Lead Sponsor
M.D. Anderson Cancer Center
Collaborators
NCT05639972
NCT06654011
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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