NCT01048853

Conservative Surgery in Treating Patients With Low-Risk Stage IA2 or IB1 Cervical Cancer

Conservative Surgery for Women With Low-Risk, Early Stage Cervical Cancer

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cervical Adenocarcinoma
• Cervical Squamous Cell Carcinoma, Not Otherwise Specified
• Stage IA2 Cervical Cancer AJCC v6 and v7
• Stage IB1 Cervical Cancer AJCC v6 and v7

Interventions

Type	Name	Description
PROCEDURE	Lymph Node Mapping	Undergo lymphatic mapping with sentinel lymph node biopsy
OTHER	Quality-of-Life Assessment	Ancillary studies
PROCEDURE	Salpingo-Oophorectomy	Undergo hysterectomy with or without salpingo-oophorectomy
PROCEDURE	Sentinel Lymph Node Biopsy	Undergo lymphatic mapping with sentinel lymph node biopsy
PROCEDURE	Therapeutic Conventional Surgery	Undergo hysterectomy with or without salpingo-oophorectomy

Timeline

• Start date: 2010-04-15
• Primary completion: 2024-12-31
• Completion: 2025-12-05
• First posted: 2010-01-14
• Last updated: 2026-01-07
• Results posted: 2025-11-26

Locations

20 sites across 8 countries: United States, Argentina, Australia, Brazil, Colombia, Mexico, Peru, Thailand

Regulatory

• FDA-regulated drug study