Study Stopped
\< 75% participation
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
2 other identifiers
interventional
137
8 countries
20
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2010
Longer than P75 for not_applicable
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2010
CompletedFirst Posted
Study publicly available on registry
January 14, 2010
CompletedStudy Start
First participant enrolled
April 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedResults Posted
Study results publicly available
November 26, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 5, 2025
CompletedJanuary 7, 2026
January 1, 2026
14.7 years
January 12, 2010
October 8, 2025
January 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
2 years
Number of Participants With All-Cause Mortality
Approximately 9 years
Study Arms (1)
Treatment (conservative surgery)
EXPERIMENTALPatients 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.
Interventions
Undergo lymphatic mapping with sentinel lymph node biopsy
Ancillary studies
Undergo hysterectomy with or without salpingo-oophorectomy
Undergo lymphatic mapping with sentinel lymph node biopsy
Undergo hysterectomy with or without salpingo-oophorectomy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (20)
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
MD Anderson Cancer Center at Cooper-Voorhees
Voorhees Township, New Jersey, 08043, United States
Northwell Health Imbert Cancer Center
Bay Shore, New York, 11706, United States
Lyndon Baines Johnson General Hospital
Houston, Texas, 77026-1967, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
The Woman's Hospital of Texas
Houston, Texas, 77054, United States
MD Anderson in Katy
Houston, Texas, 77094, United States
MD Anderson League City
Nassau Bay, Texas, 77058, United States
MD Anderson in Sugar Land
Sugar Land, Texas, 77478, United States
MD Anderson in The Woodlands
The Woodlands, Texas, 77384, United States
Hospital Italiano of Buenos Aires
Buenos Aires, 1181, Argentina
Hospital Israelita Buenos Aires
Buenos Aires, 1407, Argentina
Instituto de Oncologia Angel H Roffo
Buenos Aires, 1417, Argentina
Royal Women's Hosptial
Melbourne, Victoria, 3052, Australia
Hosptial de Cancer de Barretos
Barretos, São Paulo, 14784, Brazil
Instituto Nacional De Cancerologia
Bogotá, 99999, Colombia
Instituto Nacional De Cancerologia de Mexico
Mexico City, Tlalpan, 14080, Mexico
Instituto Nacional de Enfermedades Neoplasicas
Lima, Lima 34, Peru
King Chulalongkorn University
Bangkok, Pathumwan, 10330, Thailand
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kathleen Schmeler, MD
- Organization
- The University of Texas MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Kathleen M Schmeler
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2010
First Posted
January 14, 2010
Study Start
April 15, 2010
Primary Completion
December 31, 2024
Study Completion
December 5, 2025
Last Updated
January 7, 2026
Results First Posted
November 26, 2025
Record last verified: 2026-01