Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Blood and Lymph Conditions

Behaviors and Mental Disorders

Carcinoma

Carcinoma, Squamous Cell

Adenocarcinoma

Uterine Cervical Neoplasms

Lymphedema

Carcinoma, Adenosquamous

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Lymphatic Diseases

Quality of Life

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

Conization

Quality-of-Life Assessment

Questionnaire Administration

Therapeutic Conventional Surgery

Therapeutic Lymphadenectomy

Allan L Covens

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.

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.

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

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

Analysis of variance methods with repeated measurements and a time component will initially be used to determine whether there are significant changes over time.

Based on Cancer Lymphedema Questionnaire score.

Graded according to Common Terminology Criteria for Adverse Events version 4.0 (version 5.0 will be used staring April 1, 2018).

Will be assessed based on Functional Assessment of Cancer Therapy-Cervix (15 items) score. Analysis of variance methods with repeated measurements and a time component will initially be used to determine whether there are significant changes over time.

Classified as either local (pelvis regions, including vaginal) or distant (abdomen, lung, bone, brain, and other).

Product-limit estimates according to the method of Kaplan and Meier will be used to estimate recurrence-free survival. In addition, Cox proportional hazard regression will be employed to evaluate relative risk (hazard ratio) adjusting for known prognostic factors. Trellis plots will be used to display point estimates of hazard ratio and respective 95% confidence intervals from subgroup analyses. Local recurrence will be summarized using frequency tables and plot of cumulative incidence of local recurrence over time.

Product-limit estimates according to the method of Kaplan and Meier will be used to estimate overall survival. In addition, cox proportional hazard regression will be employed to evaluate relative risk (hazard ratio) adjusting for known prognostic factors. Trellis plots will be used to display point estimates of hazard ratio and respective 95% confidence intervals from subgroup analyses. Gompertz hazard regression will also be employed to evaluate relative risk (hazard ratio) and cure rates, adjusting for known prognostics factors.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Studying the Physical Function and Quality of Life Before and After Surgery in Patients With Stage I Cervical Cancer	NCT01649089	Cervical Adenoc... Cervical Adenos... Cervical Squamo... Lymphedema Stage IA1 Cervi... Stage IA2 Cervi... Stage IB1 Cervi...	Conization Quality-of-Life... Questionnaire A... Therapeutic Con... Therapeutic Lym...	18 Years -	GOG Foundation
Studying the Physical Function and Quality of Life Before and After Surgery in Patients With Stage I Cervical Cancer	NCT01649089	Cervical Adenoc... Cervical Adenos... Cervical Squamo... Lymphedema Stage IA1 Cervi... Stage IA2 Cervi... Stage IB1 Cervi...	Conization Quality-of-Life... Questionnaire A... Therapeutic Con... Therapeutic Lym...	18 Years -	GOG Foundation

Spots Global Cancer Trial Database for stage ib1 cervical cancer ajcc v6 and v7