Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
This clinical trial studies the physical function and quality-of-life before and after
surgery in patients with stage I cervical cancer. Studying quality-of-life in patients
undergoing surgery for cervical cancer may help determine the intermediate-term and long-term
effects of surgery.
Phase
N/A
Funding Agency/Sponsor
National Cooperative Group
Disease
Gynecologic Cancer
Enrollment 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 (LEEP); depth of invasion must be =< 10 mm
- Patients must have no evidence of metastasis on positron emission tomography (PET)
scan or 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 > 10 mm 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