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
- Diseases
- Cervical cancer, Childhood cancers
- 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
Sites (20)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto de Oncologia Angel H. Roffo | Buenos Aires | Argentina | Unknown status |
| Hospital Italiano of Buenos Aires | Buenos Aires | Argentina | Unknown status |
| Hospital Israelita Buenos Aires | Buenos Aires | Argentina | Unknown status |
| Royal Women's Hosptial | Melbourne | Australia | Unknown status |
| Hosptial de Cancer de Barretos | Barretos | Brazil | Unknown status |
| Instituto Nacional de Cancerologia | Bogota | Colombia | Unknown status |
| Instituto Nacional De Cancerologia de Mexico | Mexico City | Mexico | Unknown status |
| Instituto Nacional de Enfermedades Neoplasicas | Lima | Peru | Unknown status |
| King Chulalongkorn University | Bangkok | Thailand | Unknown status |
| Northwell Health Imbert Cancer Center | Bay Shore | United States | Unknown status |
| Lyndon Baines Johnson General Hospital | Houston | United States | Unknown status |
| The Woman's Hospital of Texas | Houston | United States | Unknown status |
| MD Anderson in Katy | Houston | United States | Unknown status |
| M D Anderson Cancer Center | Houston | United States | Unknown status |
| Baptist MD Anderson Cancer Center | Jacksonville | United States | Unknown status |
| MD Anderson League City | Nassau Bay | United States | Unknown status |
| Nebraska Methodist Hospital | Omaha | United States | Unknown status |
| MD Anderson in Sugar Land | Sugar Land | United States | Unknown status |
| MD Anderson in The Woodlands | The Woodlands | United States | Unknown status |
| MD Anderson Cancer Center at Cooper-Voorhees | Voorhees Township | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.