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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

Status
Active
Cancer Type
Cervical Cancer
Trial Phase
Phase I
Eligibility
18 and over, Female
Study Type
Natural history/Epidemiology
Supportive care
NCT ID
NCT01649089
Protocol IDs
GOG-0278 (primary)
NCI-2012-01990
CDR0000737208
U10CA101165
Study Sponsor
Gynecologic Oncology Group

Summary

This 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.

Objectives

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 (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 (lymphatic vessel invasion [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 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 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: 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.

Treatment Sites in Georgia

SJC Oncology Services


225 Candler Drive
Suite 100
Savannah, GA 31405
www.sjchs.org

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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