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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
137
Undergo lymphatic mapping with sentinel lymph node biopsy
Ancillary studies
Undergo hysterectomy with or without salpingo-oophorectomy
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States
Nebraska Methodist Hospital
Safety and Feasibility of Performing Conservative Surgery in Women With Stage IA2 or IB1 Carcinoma of the Cervix With Favorable Pathologic Features
The proposed treatment strategy will be considered not feasible if the immediate failure rate is more than 3%. The immediate failure rate, defined as residual disease in the simple hysterectomy specimen of women who underwent conization followed by simple hysterectomy and lymph node assessment.
Time frame: Approximately 9 years
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
Recurrence rate was estimated and was measured from the date of surgery to the earliest date of the last clinic visit, date of first recurrence, or date of death.
Time frame: 2 years
Number of Participants With All-Cause Mortality
Total patient morbidity within 30 days following conservative surgery
Time frame: Approximately 9 years
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Undergo lymphatic mapping with sentinel lymph node biopsy
Undergo hysterectomy with or without salpingo-oophorectomy
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