Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01649089 : Studying the Physical Function and Quality of Life Before and After Surgery in Patients With Stage I Cervical Cancer
PhaseN/A
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- Patient must consent for the appropriate surgery

- Patients with a histologic diagnosis of squamous cell carcinoma, adenocarcinoma, or
adenosquamous cell carcinoma of the cervix, stage IA1 (lymph-vascular space invasion
[LVSI]+), IA2, and IB1 (tumor size [maximum visible or palpable]) =< 2 cm), any grade

- All patients must have undergone a cone biopsy or loop electrosurgical excision
procedure (loop electrosurgical excision [LEEP]) and had negative margins for
carcinoma and high-grade dysplasia; depth of invasion must be =< 10 mm

- Patients must have no evidence of metastasis on magnetic resonance imaging (MRI) or
computed tomography (CT) scan of the pelvis and chest imaging

- Patients who have met the pre-entry requirements

- Patients must have signed an approved informed consent and authorization permitting
release of personal health information

- Patient must have Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2

Exclusion Criteria:

- Patients with Stage IA1 disease who are LVSI negative

- Patients with Stage IB1 with tumor size (maximum visible or palpable) > 2 cm

- Patients with >= stage IB2 disease

- Patients with clear cell or neuroendocrine cell types

- Patients with depth of invasion > 10mm on first cone biopsy (or LEEP)

- Patients with a history of other invasive malignancies, with the exception of
non-melanoma skin cancer, are excluded if there is any evidence of other malignancy
being present within the last five years; patients are also excluded if their
previous cancer treatment contraindicates this protocol therapy
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01649089      |      Link to official Clinicaltrials.gov listing
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