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NCT01048853Terminated

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

Source: ClinicalTrials.gov · Last updated 7 Jan 2026

Reason given: \< 75% participation

Brief summary (registry, in English)

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.

Status (registry)
Terminated
Study type
Interventional
Enrollment
137 (actual)
First submitted
12 Jan 2010
Start date
15 Apr 2010
Primary completion date
31 Dec 2024
Lead sponsor
M.D. Anderson Cancer Center
NCT number
NCT01048853

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • FIGO stage IA1, IB2, II, III or IV disease
  • 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
  • Evidence of metastatic disease on PET, CT, and/or MRI performed within 12 weeks of enrollment

Other

  • Clear cell, neuroendocrine, adenosquamous, serous carcinoma or other high-risk histologies
  • Grade 3 adenocarcinoma
  • 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
  • Patients unwilling or unable to provide informed consent for the study
  • Patients who have had a simple hysterectomy (cut through hysterectomy)

Who the study is looking for

  • 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

Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (20)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Instituto de Oncologia Angel H. RoffoBuenos AiresArgentinaUnknown status
Hospital Italiano of Buenos AiresBuenos AiresArgentinaUnknown status
Hospital Israelita Buenos AiresBuenos AiresArgentinaUnknown status
Royal Women's HosptialMelbourneAustraliaUnknown status
Hosptial de Cancer de BarretosBarretosBrazilUnknown status
Instituto Nacional de CancerologiaBogotaColombiaUnknown status
Instituto Nacional De Cancerologia de MexicoMexico CityMexicoUnknown status
Instituto Nacional de Enfermedades NeoplasicasLimaPeruUnknown status
King Chulalongkorn UniversityBangkokThailandUnknown status
Northwell Health Imbert Cancer CenterBay ShoreUnited StatesUnknown status
Lyndon Baines Johnson General HospitalHoustonUnited StatesUnknown status
The Woman's Hospital of TexasHoustonUnited StatesUnknown status
MD Anderson in KatyHoustonUnited StatesUnknown status
M D Anderson Cancer CenterHoustonUnited StatesUnknown status
Baptist MD Anderson Cancer CenterJacksonvilleUnited StatesUnknown status
MD Anderson League CityNassau BayUnited StatesUnknown status
Nebraska Methodist HospitalOmahaUnited StatesUnknown status
MD Anderson in Sugar LandSugar LandUnited StatesUnknown status
MD Anderson in The WoodlandsThe WoodlandsUnited StatesUnknown status
MD Anderson Cancer Center at Cooper-VoorheesVoorhees TownshipUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.