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

Stopped early · Not applicable

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT01048853

Run by

M.D. Anderson Cancer Center

People needed

137

Starts

2010-04-15

Expected to finish

2025-12-05

Last updated by the study team

2026-01-07

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

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)

Where it is running

• 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
• MD Anderson in The Woodlands — The Woodlands, Texas, United States
• Hospital Italiano of Buenos Aires — Buenos Aires, Argentina
• Hospital Israelita Buenos Aires — Buenos Aires, Argentina
• Instituto de Oncologia Angel H Roffo — Buenos Aires, Argentina
• Royal Women's Hosptial — Melbourne, Victoria, Australia
• Hosptial de Cancer de Barretos — Barretos, São Paulo, Brazil
• Instituto Nacional De Cancerologia — Bogotá, Colombia
• Instituto Nacional De Cancerologia de Mexico — Mexico City, Tlalpan, Mexico
• Instituto Nacional de Enfermedades Neoplasicas — Lima, Peru
• King Chulalongkorn University — Bangkok, Pathumwan, Thailand

Full record on ClinicalTrials.gov

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