Trial purpose
Cancer treatment
Tumor type
Gynaecological
Age
18 - 75
Clinical summary
Summary
The goal of this surgical research study is to learn if ""conservative surgery"" is a safe and feasible option for women with low-risk cervical cancer (stage IA2 or IB1, Grade 1 or 2).
Conditions
This trial is treating people with Cervical Cancer
Eligibility
Inclusion
- 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
Exclusion
- 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)
Inclusion
- Your cancer has not spread to other parts of the body (localised).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
M.D. Anderson Cancer Center
Scientific Title
Conservative Surgery for Women With Low-risk, Early Stage Cervical Cancer (Other ID's: 2008-0118)
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