Trial Information

Evaluation of Physical Function and Quality of Life (QOL) Before and After Non-Radical Surgical Therapy (Extra Fascial Hysterectomy or Cone Biopsy With Pelvic Lymphadenectomy) for Stage IA1 (LVSI+) and IA2-IB1 (≤ 2cm) Cervical Cancer

OBJECTIVES:

Primary

- 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 (LVSI+) and
IA2-IB1 (< 2 cm) carcinoma of the cervix.

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

Secondary

- 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).

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

- 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.

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

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

- 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: This is a multicenter study.

Patients are stratified according to their fertility wishes (cone biopsy and pelvic
lymphadenectomy [fertility preservation] vs simple hysterectomy and pelvic lymphadenectomy
[fertility preservation not desired]).

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

Patients in both groups 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 in group 1 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.