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

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.

Study Overview

• Status: Terminated
• 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
• Intervention / Treatment: Other: Quality-of-Life Assessment; Procedure: Lymph Node Mapping; Procedure: Salpingo-Oophorectomy; Procedure: Sentinel Lymph Node Biopsy; Procedure: Therapeutic Conventional Surgery

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.

• Study Type: Interventional
• Enrollment (Actual): 137
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1181
    • Hospital Italiano of Buenos Aires
  • Buenos Aires, Argentina, 1407
    • Hospital Israelita Buenos Aires
  • Buenos Aires, Argentina, 1417
    • Instituto de Oncologia Angel H Roffo
• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3052
      • Royal Women's Hosptial
• Brazil
  • São Paulo
    • Barretos, São Paulo, Brazil, 14784
      • Hosptial de Cancer de Barretos
• Colombia
  • Bogotá, Colombia, 99999
    • Instituto Nacional De Cancerologia
• Mexico
  • Tlalpan
    • Mexico City, Tlalpan, Mexico, 14080
      • Instituto Nacional De Cancerologia de Mexico
• Peru
  • Lima, Peru, Lima 34
    • Instituto Nacional de Enfermedades Neoplasicas
• Thailand
  • Pathumwan
    • Bangkok, Pathumwan, Thailand, 10330
      • King Chulalongkorn University
• United States
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Baptist MD Anderson Cancer Center
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Nebraska Methodist Hospital
  • New Jersey
    • Voorhees Township, New Jersey, United States, 08043
      • MD Anderson Cancer Center at Cooper-Voorhees
  • New York
    • Bay Shore, New York, United States, 11706
      • Northwell Health Imbert Cancer Center
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center
    • Houston, Texas, United States, 77026-1967
      • Lyndon Baines Johnson General Hospital
    • Houston, Texas, United States, 77054
      • The Woman's Hospital of Texas
    • Houston, Texas, United States, 77094
      • MD Anderson in Katy
    • Nassau Bay, Texas, United States, 77058
      • MD Anderson League City
    • Sugar Land, Texas, United States, 77478
      • MD Anderson in Sugar Land
    • The Woodlands, Texas, United States, 77384
      • MD Anderson in The Woodlands

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically confirmed squamous cell carcinoma of the cervix (any grade) or histologically confirmed grade 1 or 2 adenocarcinoma of cervix
• International Federation of Gynecology and Obstetrics (FIGO) stage IA2 or IB1 disease
• Tumor diameter =< 2 cm on physical exam and on imaging studies
• No lymphovascular space invasion (LVSI) present on biopsy or previous cone
• Less than 10 mm of cervical stromal invasion
• Cone margins and endocervical curettage (ECC) specimen negative for invasive cancer, cervical intraepithelial neoplasia (CIN) II, CIN III or adenocarcinoma-in-situ; (a negative margin is defined as no invasive cancer within 1.0 mm of both the endocervical and ectocervical margins and no adenocarcinoma in situ [AIS] or CIN II or CIN III at the inked or cauterized margin; one repeat cone and ECC permitted)
• Patients are eligible for the study when a cone and ECC are performed prior to pre-enrollment in the study, and pathologic eligibility criteria are met; the cone and ECC must be performed within 12 weeks prior to pre-enrollment in the study; if the cone and ECC performed prior to pre-enrollment do not meet the pathologic criteria, patients may be pre-enrolled and are allowed 1 repeat cone & ECC after pre-enrollment in order to meet pathologic eligibility criteria
• Patients must sign an approved informed consent document
• If patient is of childbearing potential, she must have a negative blood or urine pregnancy test within 14 days of surgical treatment on study
• Imaging with positron emission tomography (PET) scan, computed tomography (CT) scan of the abdomen and pelvis, and/or magnetic resonance imaging (MRI) of the abdomen and pelvis must be performed and negative for metastatic disease within 12 weeks of enrollment

Exclusion Criteria:

• Clear cell, neuroendocrine, adenosquamous, serous carcinoma or other high-risk histologies
• Grade 3 adenocarcinoma
• FIGO stage IA1, IB2, II, III or IV disease
• Tumors > 2 cm in diameter on physical exam or imaging studies
• Presence of LVSI
• Greater than or equal to 10 mm of cervical stromal invasion
• Cone margins or ECC specimen positive for invasive cancer, CIN II, CIN III or adenocarcinoma-in-situ (one repeat cone permitted)
• Neoadjuvant radiation therapy or chemotherapy for cervical cancer
• Patients unwilling or unable to provide informed consent for the study
• Evidence of metastatic disease on PET, CT, and/or MRI performed within 12 weeks of enrollment
• Patients who have had a simple hysterectomy (cut through hysterectomy)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment (conservative surgery); 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.

Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Procedure: Lymph Node Mapping; Undergo lymphatic mapping with sentinel lymph node biopsy; Other Names: lymphatic mapping; Procedure: Salpingo-Oophorectomy; Undergo hysterectomy with or without salpingo-oophorectomy; Procedure: Sentinel Lymph Node Biopsy; Undergo lymphatic mapping with sentinel lymph node biopsy; Other Names: Sentinel Node Biopsy; Sentinel node biopsy alone; SLNB; SNB; Procedure: Therapeutic Conventional Surgery; Undergo hysterectomy with or without salpingo-oophorectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Approximately 9 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years
Number of Participants With All-Cause Mortality	Total patient morbidity within 30 days following conservative surgery	Approximately 9 years

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Kathleen M Schmeler, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2010
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 5, 2025

Study Registration Dates

• First Submitted: January 12, 2010
• First Submitted That Met QC Criteria: January 12, 2010
• First Posted (Estimated): January 14, 2010

Study Record Updates

• Last Update Posted (Estimated): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Uterine Diseases; Genital Diseases, Female; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Carcinoma; Neoplasms, Squamous Cell; Uterine Cervical Diseases; Uterine Neoplasms; Carcinoma, Squamous Cell; Uterine Cervical Neoplasms; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Cytological Techniques; Biopsy; Cytodiagnosis; Diagnostic Techniques, Surgical; Urogenital Surgical Procedures; Gynecologic Surgical Procedures; Lymph Node Excision; Endocrine Surgical Procedures; Castration; Ovariectomy; Salpingectomy; Sentinel Lymph Node Biopsy; Salpingo-oophorectomy
• Other Study ID Numbers: 2008-0118 (Other Identifier: M D Anderson Cancer Center); NCI-2012-01254 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No