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

Lymphedema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01649089
• Other study ID #: GOG-0278
• Secondary ID: NCI-2012-01990CD
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 5, 2013
• Est. completion date: December 1, 2025

Study information

• Verified date: May 2024
• Source: GOG Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 224
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Adenosquamous
• Cervical Adenocarcinoma
• Cervical Adenosquamous Carcinoma
• Cervical Squamous Cell Carcinoma
• Lymphedema
• Stage IA1 Cervical Cancer AJCC v6 and v7
• Stage IA2 Cervical Cancer AJCC v6 and v7
• Stage IB1 Cervical Cancer AJCC v6 and v7
• Uterine Cervical Neoplasms

Intervention

Procedure:
• Conization
Undergo cone biopsy

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Procedure:
• Therapeutic Conventional Surgery
Undergo hysterectomy
• Therapeutic Lymphadenectomy
Undergo lymphadenectomy

Locations

Country	Name	City	State
Canada	Odette Cancer Centre- Sunnybrook Health Sciences Centre	Toronto	Ontario
Korea, Republic of	Gachon University Gil Hospital	Incheon
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam City	Kyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Catholic University of Korea-Seoul Saint Mary's Hospital	Seoul	Korea
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Korea Cancer Center Hospital	Seoul
Korea, Republic of	Kyung Hee University Hospital at Gangdong	Seoul
Korea, Republic of	Samsung Medical Center	Seoul	Korea
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Yonsei University Health System-Severance Hospital	Seoul
United States	Jefferson Abington Hospital	Abington	Pennsylvania
United States	Summa Health System - Akron Campus	Akron	Ohio
United States	Sutter Auburn Faith Hospital	Auburn	California
United States	Sutter Cancer Centers Radiation Oncology Services-Auburn	Auburn	California
United States	Memorial Sloan Kettering Basking Ridge	Basking Ridge	New Jersey
United States	Hematology/Oncology Clinic PLLC	Baton Rouge	Louisiana
United States	Woman's Hospital	Baton Rouge	Louisiana
United States	Strecker Cancer Center-Belpre	Belpre	Ohio
United States	Alta Bates Summit Medical Center-Herrick Campus	Berkeley	California
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Mills-Peninsula Medical Center	Burlingame	California
United States	Fairview Ridges Hospital	Burnsville	Minnesota
United States	Cooper Hospital University Medical Center	Camden	New Jersey
United States	Sutter Cancer Centers Radiation Oncology Services-Cameron Park	Cameron Park	California
United States	Aultman Health Foundation	Canton	Ohio
United States	Eden Hospital Medical Center	Castro Valley	California
United States	Cancer Center of Kansas - Chanute	Chanute	Kansas
United States	Adena Regional Medical Center	Chillicothe	Ohio
United States	University of Cincinnati Cancer Center-UC Medical Center	Cincinnati	Ohio
United States	Case Western Reserve University	Cleveland	Ohio
United States	Cleveland Clinic Cancer Center/Fairview Hospital	Cleveland	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Columbus Oncology and Hematology Associates Inc	Columbus	Ohio
United States	Doctors Hospital	Columbus	Ohio
United States	Grant Medical Center	Columbus	Ohio
United States	Mount Carmel East Hospital	Columbus	Ohio
United States	Mount Carmel Health Center West	Columbus	Ohio
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	The Mark H Zangmeister Center	Columbus	Ohio
United States	Memorial Sloan Kettering Commack	Commack	New York
United States	Mercy Hospital	Coon Rapids	Minnesota
United States	Baptist Health Corbin	Corbin	Kentucky
United States	Parkland Memorial Hospital	Dallas	Texas
United States	UT Southwestern/Simmons Cancer Center-Dallas	Dallas	Texas
United States	Sutter Davis Hospital	Davis	California
United States	Grandview Hospital	Dayton	Ohio
United States	UM Sylvester Comprehensive Cancer Center at Deerfield Beach	Deerfield Beach	Florida
United States	Delaware Health Center-Grady Cancer Center	Delaware	Ohio
United States	Delaware Radiation Oncology	Delaware	Ohio
United States	Grady Memorial Hospital	Delaware	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	Cancer Center of Kansas - Dodge City	Dodge City	Kansas
United States	Dublin Methodist Hospital	Dublin	Ohio
United States	Fairview Southdale Hospital	Edina	Minnesota
United States	Cancer Center of Kansas - El Dorado	El Dorado	Kansas
United States	Cancer Center of Kansas - Fort Scott	Fort Scott	Kansas
United States	Palo Alto Medical Foundation-Fremont	Fremont	California
United States	Unity Hospital	Fridley	Minnesota
United States	Central Ohio Breast and Endocrine Surgery	Gahanna	Ohio
United States	Northwestern Medicine Cancer Center Delnor	Geneva	Illinois
United States	Mount Carmel Grove City Hospital	Grove City	Ohio
United States	Memorial Sloan Kettering Westchester	Harrison	New York
United States	Sudarshan K Sharma MD Limited-Gynecologic Oncology	Hinsdale	Illinois
United States	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii
United States	Queen's Medical Center	Honolulu	Hawaii
United States	University of Hawaii Cancer Center	Honolulu	Hawaii
United States	Memorial Hermann Texas Medical Center	Houston	Texas
United States	Hutchinson Area Health Care	Hutchinson	Minnesota
United States	Cancer Center of Kansas-Independence	Independence	Kansas
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Mercy Hospital Joplin	Joplin	Missouri
United States	Cancer Center of Kansas-Kingman	Kingman	Kansas
United States	UC San Diego Moores Cancer Center	La Jolla	California
United States	Fairfield Medical Center	Lancaster	Ohio
United States	Women's Cancer Center of Nevada	Las Vegas	Nevada
United States	Lawrence Memorial Hospital	Lawrence	Kansas
United States	Baptist Health Lexington	Lexington	Kentucky
United States	Cancer Center of Kansas-Liberal	Liberal	Kansas
United States	Saint Rita's Medical Center	Lima	Ohio
United States	Kaiser Permanente Los Angeles Medical Center	Los Angeles	California
United States	Baptist Health Madisonville/Merle Mahr Cancer Center	Madisonville	Kentucky
United States	Cancer Center of Kansas-Manhattan	Manhattan	Kansas
United States	OhioHealth Mansfield Hospital	Mansfield	Ohio
United States	Fairview Clinics and Surgery Center Maple Grove	Maple Grove	Minnesota
United States	Minnesota Oncology Hematology PA-Maplewood	Maplewood	Minnesota
United States	Saint John's Hospital - Healtheast	Maplewood	Minnesota
United States	Marietta Memorial Hospital	Marietta	Ohio
United States	OhioHealth Marion General Hospital	Marion	Ohio
United States	Hillcrest Hospital Cancer Center	Mayfield Heights	Ohio
United States	Cancer Center of Kansas - McPherson	McPherson	Kansas
United States	UH Seidman Cancer Center at Lake Health Mentor Campus	Mentor	Ohio
United States	Jackson Memorial Hospital-Holtz Children's Hospital	Miami	Florida
United States	University of Miami Miller School of Medicine-Sylvester Cancer Center	Miami	Florida
United States	Memorial Sloan Kettering Monmouth	Middletown	New Jersey
United States	Aurora Saint Luke's Medical Center	Milwaukee	Wisconsin
United States	Abbott-Northwestern Hospital	Minneapolis	Minnesota
United States	Health Partners Inc	Minneapolis	Minnesota
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	Memorial Medical Center	Modesto	California
United States	Monongalia Hospital	Morgantown	West Virginia
United States	Good Samaritan Regional Health Center	Mount Vernon	Illinois
United States	Knox Community Hospital	Mount Vernon	Ohio
United States	Palo Alto Medical Foundation-Camino Division	Mountain View	California
United States	Palo Alto Medical Foundation-Gynecologic Oncology	Mountain View	California
United States	ProHealth D N Greenwald Center	Mukwonago	Wisconsin
United States	Tulane University Health Sciences Center	New Orleans	Louisiana
United States	Cancer Center of Western Wisconsin	New Richmond	Wisconsin
United States	New Ulm Medical Center	New Ulm	Minnesota
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Licking Memorial Hospital	Newark	Ohio
United States	Newark Radiation Oncology	Newark	Ohio
United States	Cancer Center of Kansas - Newton	Newton	Kansas
United States	ProHealth Oconomowoc Memorial Hospital	Oconomowoc	Wisconsin
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Nebraska Methodist Hospital	Omaha	Nebraska
United States	UC Irvine Health/Chao Family Comprehensive Cancer Center	Orange	California
United States	AdventHealth Orlando	Orlando	Florida
United States	Baptist Health Paducah	Paducah	Kentucky
United States	Palo Alto Medical Foundation Health Care	Palo Alto	California
United States	Paoli Memorial Hospital	Paoli	Pennsylvania
United States	Cancer Center of Kansas - Parsons	Parsons	Kansas
United States	Mercy Health Perrysburg Cancer Center	Perrysburg	Ohio
United States	Cancer Center at Saint Joseph's	Phoenix	Arizona
United States	Saint Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	UM Sylvester Comprehensive Cancer Center at Plantation	Plantation	Florida
United States	Naval Medical Center - Portsmouth	Portsmouth	Virginia
United States	Southern Ohio Medical Center	Portsmouth	Ohio
United States	Cancer Center of Kansas - Pratt	Pratt	Kansas
United States	Women and Infants Hospital	Providence	Rhode Island
United States	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia
United States	North Memorial Medical Health Center	Robbinsdale	Minnesota
United States	University of Rochester	Rochester	New York
United States	Mercy Clinic-Rolla-Cancer and Hematology	Rolla	Missouri
United States	Sutter Cancer Centers Radiation Oncology Services-Roseville	Roseville	California
United States	Sutter Roseville Medical Center	Roseville	California
United States	Sutter Medical Center Sacramento	Sacramento	California
United States	Mercy Hospital Saint Louis	Saint Louis	Missouri
United States	Saint Louis Cancer and Breast Institute-South City	Saint Louis	Missouri
United States	Park Nicollet Clinic - Saint Louis Park	Saint Louis Park	Minnesota
United States	Regions Hospital	Saint Paul	Minnesota
United States	United Hospital	Saint Paul	Minnesota
United States	Cancer Center of Kansas - Salina	Salina	Kansas
United States	California Pacific Medical Center-Pacific Campus	San Francisco	California
United States	Palo Alto Medical Foundation-Santa Cruz	Santa Cruz	California
United States	Sutter Pacific Medical Foundation	Santa Rosa	California
United States	Lewis Cancer and Research Pavilion at Saint Joseph's/Candler	Savannah	Georgia
United States	Saint Francis Regional Medical Center	Shakopee	Minnesota
United States	Baystate Medical Center	Springfield	Massachusetts
United States	CoxHealth South Hospital	Springfield	Missouri
United States	Mercy Hospital Springfield	Springfield	Missouri
United States	Lakeview Hospital	Stillwater	Minnesota
United States	Palo Alto Medical Foundation-Sunnyvale	Sunnyvale	California
United States	Olive View-University of California Los Angeles Medical Center	Sylmar	California
United States	ProMedica Flower Hospital	Sylvania	Ohio
United States	Mercy Health - Saint Anne Hospital	Toledo	Ohio
United States	ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital	Toledo	Ohio
United States	Saint Vincent Mercy Medical Center	Toledo	Ohio
United States	Oklahoma Cancer Specialists and Research Institute-Tulsa	Tulsa	Oklahoma
United States	Memorial Sloan Kettering Nassau	Uniondale	New York
United States	Sutter Cancer Centers Radiation Oncology Services-Vacaville	Vacaville	California
United States	Sutter Solano Medical Center/Cancer Center	Vallejo	California
United States	MD Anderson Cancer Center at Cooper-Voorhees	Voorhees	New Jersey
United States	Ridgeview Medical Center	Waconia	Minnesota
United States	Northwestern Medicine Cancer Center Warrenville	Warrenville	Illinois
United States	ProHealth Waukesha Memorial Hospital	Waukesha	Wisconsin
United States	UW Cancer Center at ProHealth Care	Waukesha	Wisconsin
United States	Cancer Center of Kansas - Wellington	Wellington	Kansas
United States	Aurora West Allis Medical Center	West Allis	Wisconsin
United States	Saint Ann's Hospital	Westerville	Ohio
United States	Ascension Via Christi Hospitals Wichita	Wichita	Kansas
United States	Associates In Womens Health	Wichita	Kansas
United States	Cancer Center of Kansas - Wichita	Wichita	Kansas
United States	Cancer Center of Kansas-Wichita Medical Arts Tower	Wichita	Kansas
United States	Rice Memorial Hospital	Willmar	Minnesota
United States	Asplundh Cancer Pavilion	Willow Grove	Pennsylvania
United States	Cancer Center of Kansas - Winfield	Winfield	Kansas
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina
United States	Minnesota Oncology Hematology PA-Woodbury	Woodbury	Minnesota
United States	Lankenau Medical Center	Wynnewood	Pennsylvania
United States	Fairview Lakes Medical Center	Wyoming	Minnesota
United States	Genesis Healthcare System Cancer Care Center	Zanesville	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
GOG Foundation	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in bladder and bowel function score based on supplemental bladder and bowel questions plus 4 items from the Functional Assessment of Cancer Therapy-Cervix (3 bladder and 1 bowel question)	Analysis of variance methods with repeated measurements and a time component will initially be used to determine whether there are significant changes over time.	Baseline to 3 years
Primary	Change in sexual function and activity based on Female Sexual Function Index (19 items) score plus 2 Patient Reported Outcomes Measurement Information System screener items	Analysis of variance methods with repeated measurements and a time component will initially be used to determine whether there are significant changes over time.	Baseline to 3 years
Primary	Lymphedema	Based on Cancer Lymphedema Questionnaire score.	Up to 3 years
Primary	Maximum grade and duration of severe adverse events associated with bladder, bowel, and sexual dysfunction and lymphedema	Graded according to Common Terminology Criteria for Adverse Events version 4.0 (version 5.0 will be used staring April 1, 2018).	Up to 3 years after non-radical surgical procedure
Secondary	Maximum grade of treatment-related adverse events	Graded according to Common Terminology Criteria for Adverse Events version 4.0 (version 5.0 will be used staring April 1, 2018).	Up to 30 days after surgical procedure
Secondary	Change in overall quality of life	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.	Baseline to 3 years
Secondary	Change in cancer worries based on Impact of Events 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.	Baseline to 3 years
Secondary	Change in reproductive concerns based on reproductive concerns (14 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.	Baseline to 3 years
Secondary	Site of first recurrence	Classified as either local (pelvis regions, including vaginal) or distant (abdomen, lung, bone, brain, and other).	Up to 3 years
Secondary	Recurrence-free survival	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.	Up to 3 years
Secondary	Overall survival	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.	Up to 3 years