Studying the Physical Function and Quality of Life Before and After Surgery in Patients With Stage I Cervical Cancer

PRIMARY OBJECTIVES:

I. To examine the changes before and after non-radical surgical treatment (simple
hysterectomy or cone biopsy [fertility preservation]) and pelvic lymphadenectomy) on
functional outcomes of bladder, bowel, and sexual function for stage IA1 (lymphatic vessel
invasion positive [LVSI+]) and IA2-IB1 (=< 2 cm) carcinoma of the cervix.

II. To evaluate incidence and severity of lymphedema after non-radical surgery (simple
hysterectomy or cone biopsy [fertility preservation] and pelvic lymphadenectomy) for stage
IA1 (LVSI+) and IA2-IB1 (=< 2 cm) carcinoma of the cervix.

SECONDARY OBJECTIVES:

I. To investigate if non-radical surgery (simple hysterectomy or cone biopsy [fertility
preservation] with pelvic lymphadenectomy) demonstrates greater physical function and less
toxicity in comparison to historical data on radical surgery (radical hysterectomy or radical
trachelectomy).

II. To evaluate incidence and severity of treatment-related adverse events, including
surgical complications, among the entire cohort and by treatment type.

III. To evaluate changes in quality of life (QOL) (Functional Assessment of Cancer
Therapy-Cervix [FACT-Cx]), cancer worries (Impact of Events Scale [IES]) and sexual (Female
Sexual Function Index [FSFI])/reproductive concerns (RCS) among the entire cohort and by
treatment type.

IV. To explore relationships (correlation, interaction, independence) between functional
outcomes (i.e., bladder function, bowel function, sexual function), adverse events (including
and surgical complication lymphedema [Gynecologic Cancer Lymphedema Questionnaire (GCLQ)]),
cancer worry (IES), surgical complications, and overall quality of life (FACT-Cx).

V. To determine participants? intention for conception & fertility rates (Integrative Care
for Fertility [ICF]) and assess the reproductive concerns (RCS) of women following cone
biopsy and pelvic lymphadenectomy for stage IA1 (LVSI+) and IA2-IB1 (=< 2 cm) carcinoma of
the cervix.

VI. To estimate the efficacy of non-radical surgery (simple hysterectomy or cone biopsy
[fertility preservation] and pelvic lymphadenectomy) for stage IA1 (LVSI+) and IA2-IB1 (=< 2
cm) carcinoma of the cervix.

OUTLINE:

Patients undergo cone biopsy and pelvic lymphadenectomy or simple hysterectomy and pelvic
lymphadenectomy.

Patients complete the FACT-Cx, the IES, the FSFI, the GCLQ, and the Patient Reported Outcomes
Measurement Information System (PROMIS) questionnaires at baseline, 4-6 weeks after surgery,
and then every 6 months for 3 years. Patients undergoing cone biopsy and pelvic
lymphadenectomy also complete the ICF and RCS questionnaires.

After completion of study treatment, patients are followed up at 4-6 weeks, every 3 months
for 1 year, and then every 6 months for 2 years.

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