Conservative Surgery in Treating Patients With Low-Risk Stage IA2 or IB1 Cervical Cancer (NCT01048853) | Clinical Trial Compass
TerminatedNot Applicable
Conservative Surgery in Treating Patients With Low-Risk Stage IA2 or IB1 Cervical Cancer
Stopped: \< 75% participation
United States137 participantsStarted 2010-04-15
Plain-language 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.
Who can participate
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ā¦
What they're measuring
1
Safety and Feasibility of Performing Conservative Surgery in Women With Stage IA2 or IB1 Carcinoma of the Cervix With Favorable Pathologic Features