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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lymphedema; Cervical Adenocarcinoma; Cervical Adenosquamous Carcinoma; Cervical Squamous Cell Carcinoma; Stage IA2 Cervical Cancer AJCC v6 and v7; Stage IB1 Cervical Cancer AJCC v6 and v7; Stage IA1 Cervical Cancer AJCC v6 and v7
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Conization; Procedure: Therapeutic Conventional Surgery; Procedure: Therapeutic Lymphadenectomy

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 224
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Odette Cancer Centre- Sunnybrook Health Sciences Centre
• Korea, Republic of
  • Incheon, Korea, Republic of, 405-760
    • Gachon University Gil Hospital
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 120-752
    • Yonsei University Health System-Severance Hospital
  • Seoul, Korea, Republic of, 134-727
    • Kyung Hee University Hospital at Gangdong
  • Seoul, Korea, Republic of, 06273
    • Gangnam Severance Hospital
  • Seoul, Korea, Republic of, 139-706
    • Korea Cancer Center Hospital
  • Korea
    • Seoul, Korea, Korea, Republic of, 135-710
      • Samsung Medical Center
    • Seoul, Korea, Korea, Republic of, 137-040
      • Catholic University of Korea-Seoul Saint Mary's Hospital
  • Kyeonggi-do
    • Seongnam City, Kyeonggi-do, Korea, Republic of, 463-707
      • Seoul National University Bundang Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Cancer Center at Saint Joseph's
    • Phoenix, Arizona, United States, 85013
      • Saint Joseph's Hospital and Medical Center
  • California
    • Auburn, California, United States, 95602
      • Sutter Auburn Faith Hospital
    • Auburn, California, United States, 95603
      • Sutter Cancer Centers Radiation Oncology Services-Auburn
    • Berkeley, California, United States, 94704
      • Alta Bates Summit Medical Center-Herrick Campus
    • Burlingame, California, United States, 94010
      • Mills-Peninsula Medical Center
    • Cameron Park, California, United States, 95682
      • Sutter Cancer Centers Radiation Oncology Services-Cameron Park
    • Castro Valley, California, United States, 94546
      • Eden Hospital Medical Center
    • Davis, California, United States, 95616
      • Sutter Davis Hospital
    • Fremont, California, United States, 94538
      • Palo Alto Medical Foundation-Fremont
    • La Jolla, California, United States, 92093
      • UC San Diego Moores Cancer Center
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente Los Angeles Medical Center
    • Modesto, California, United States, 95355
      • Memorial Medical Center
    • Mountain View, California, United States, 94040
      • Palo Alto Medical Foundation-Camino Division
    • Mountain View, California, United States, 94040
      • Palo Alto Medical Foundation-Gynecologic Oncology
    • Orange, California, United States, 92868
      • UC Irvine Health/Chao Family Comprehensive Cancer Center
    • Palo Alto, California, United States, 94301
      • Palo Alto Medical Foundation Health Care
    • Roseville, California, United States, 95661
      • Sutter Cancer Centers Radiation Oncology Services-Roseville
    • Roseville, California, United States, 95661
      • Sutter Roseville Medical Center
    • Sacramento, California, United States, 95816
      • Sutter Medical Center Sacramento
    • San Francisco, California, United States, 94115
      • California Pacific Medical Center-Pacific Campus
    • Santa Cruz, California, United States, 95065
      • Palo Alto Medical Foundation-Santa Cruz
    • Santa Rosa, California, United States, 95403
      • Sutter Pacific Medical Foundation
    • Sunnyvale, California, United States, 94086
      • Palo Alto Medical Foundation-Sunnyvale
    • Sylmar, California, United States, 91342
      • Olive View-University of California Los Angeles Medical Center
    • Vacaville, California, United States, 95687
      • Sutter Cancer Centers Radiation Oncology Services-Vacaville
    • Vallejo, California, United States, 94589
      • Sutter Solano Medical Center/Cancer Center
  • Florida
    • Deerfield Beach, Florida, United States, 33442
      • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
    • Miami, Florida, United States, 33136
      • University of Miami Miller School of Medicine-Sylvester Cancer Center
    • Miami, Florida, United States, 33136
      • Jackson Memorial Hospital-Holtz Children's Hospital
    • Orlando, Florida, United States, 32803
      • AdventHealth Orlando
    • Plantation, Florida, United States, 33324
      • UM Sylvester Comprehensive Cancer Center at Plantation
  • Georgia
    • Savannah, Georgia, United States, 31405
      • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Queen's Medical Center
    • Honolulu, Hawaii, United States, 96813
      • University of Hawaii Cancer Center
    • Honolulu, Hawaii, United States, 96826
      • Kapiolani Medical Center for Women and Children
  • Illinois
    • Geneva, Illinois, United States, 60134
      • Northwestern Medicine Cancer Center Delnor
    • Hinsdale, Illinois, United States, 60521
      • Sudarshan K Sharma MD Limited-Gynecologic Oncology
    • Mount Vernon, Illinois, United States, 62864
      • Good Samaritan Regional Health Center
    • Warrenville, Illinois, United States, 60555
      • Northwestern Medicine Cancer Center Warrenville
  • Kansas
    • Chanute, Kansas, United States, 66720
      • Cancer Center of Kansas - Chanute
    • Dodge City, Kansas, United States, 67801
      • Cancer Center of Kansas - Dodge City
    • El Dorado, Kansas, United States, 67042
      • Cancer Center of Kansas - El Dorado
    • Fort Scott, Kansas, United States, 66701
      • Cancer Center of Kansas - Fort Scott
    • Independence, Kansas, United States, 67301
      • Cancer Center of Kansas-Independence
    • Kingman, Kansas, United States, 67068
      • Cancer Center of Kansas-Kingman
    • Lawrence, Kansas, United States, 66044
      • Lawrence Memorial Hospital
    • Liberal, Kansas, United States, 67905
      • Cancer Center of Kansas-Liberal
    • Manhattan, Kansas, United States, 66502
      • Cancer Center of Kansas-Manhattan
    • McPherson, Kansas, United States, 67460
      • Cancer Center of Kansas - McPherson
    • Newton, Kansas, United States, 67114
      • Cancer Center of Kansas - Newton
    • Parsons, Kansas, United States, 67357
      • Cancer Center of Kansas - Parsons
    • Pratt, Kansas, United States, 67124
      • Cancer Center of Kansas - Pratt
    • Salina, Kansas, United States, 67401
      • Cancer Center of Kansas - Salina
    • Wellington, Kansas, United States, 67152
      • Cancer Center of Kansas - Wellington
    • Wichita, Kansas, United States, 67214
      • Ascension Via Christi Hospitals Wichita
    • Wichita, Kansas, United States, 67208
      • Cancer Center of Kansas-Wichita Medical Arts Tower
    • Wichita, Kansas, United States, 67214
      • Cancer Center of Kansas - Wichita
    • Wichita, Kansas, United States, 67208
      • Associates In Womens Health
    • Winfield, Kansas, United States, 67156
      • Cancer Center of Kansas - Winfield
  • Kentucky
    • Corbin, Kentucky, United States, 40701
      • Baptist Health Corbin
    • Lexington, Kentucky, United States, 40503
      • Baptist Health Lexington
    • Madisonville, Kentucky, United States, 42431
      • Baptist Health Madisonville/Merle Mahr Cancer Center
    • Paducah, Kentucky, United States, 42003
      • Baptist Health Paducah
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Hematology/Oncology Clinic PLLC
    • Baton Rouge, Louisiana, United States, 70817
      • Woman's Hospital
    • New Orleans, Louisiana, United States, 70112
      • Tulane University Health Sciences Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • Minnesota
    • Burnsville, Minnesota, United States, 55337
      • Fairview Ridges Hospital
    • Coon Rapids, Minnesota, United States, 55433
      • Mercy Hospital
    • Edina, Minnesota, United States, 55435
      • Fairview Southdale Hospital
    • Fridley, Minnesota, United States, 55432
      • Unity Hospital
    • Hutchinson, Minnesota, United States, 55350
      • Hutchinson Area Health Care
    • Maple Grove, Minnesota, United States, 55369
      • Fairview Clinics and Surgery Center Maple Grove
    • Maplewood, Minnesota, United States, 55109
      • Saint John's Hospital - Healtheast
    • Maplewood, Minnesota, United States, 55109
      • Minnesota Oncology Hematology PA-Maplewood
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center
    • Minneapolis, Minnesota, United States, 55407
      • Abbott-Northwestern Hospital
    • Minneapolis, Minnesota, United States, 55454
      • Health Partners Inc
    • New Ulm, Minnesota, United States, 56073
      • New Ulm Medical Center
    • Robbinsdale, Minnesota, United States, 55422
      • North Memorial Medical Health Center
    • Saint Louis Park, Minnesota, United States, 55416
      • Park Nicollet Clinic - Saint Louis Park
    • Saint Paul, Minnesota, United States, 55101
      • Regions Hospital
    • Saint Paul, Minnesota, United States, 55102
      • United Hospital
    • Shakopee, Minnesota, United States, 55379
      • Saint Francis Regional Medical Center
    • Stillwater, Minnesota, United States, 55082
      • Lakeview Hospital
    • Waconia, Minnesota, United States, 55387
      • Ridgeview Medical Center
    • Willmar, Minnesota, United States, 56201
      • Rice Memorial Hospital
    • Woodbury, Minnesota, United States, 55125
      • Minnesota Oncology Hematology PA-Woodbury
    • Wyoming, Minnesota, United States, 55092
      • Fairview Lakes Medical Center
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • Missouri
    • Joplin, Missouri, United States, 64804
      • Mercy Hospital Joplin
    • Rolla, Missouri, United States, 65401
      • Mercy Clinic-Rolla-Cancer and Hematology
    • Saint Louis, Missouri, United States, 63141
      • Mercy Hospital Saint Louis
    • Saint Louis, Missouri, United States, 63109
      • Saint Louis Cancer and Breast Institute-South City
    • Springfield, Missouri, United States, 65807
      • CoxHealth South Hospital
    • Springfield, Missouri, United States, 65804
      • Mercy Hospital Springfield
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Nebraska Methodist Hospital
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Women's Cancer Center of Nevada
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Memorial Sloan Kettering Basking Ridge
    • Camden, New Jersey, United States, 08103
      • Cooper Hospital University Medical Center
    • Middletown, New Jersey, United States, 07748
      • Memorial Sloan Kettering Monmouth
    • Voorhees, New Jersey, United States, 08043
      • MD Anderson Cancer Center at Cooper-Voorhees
  • New York
    • Commack, New York, United States, 11725
      • Memorial Sloan Kettering Commack
    • Harrison, New York, United States, 10604
      • Memorial Sloan Kettering Westchester
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • Rochester, New York, United States, 14642
      • University of Rochester
    • Uniondale, New York, United States, 11553
      • Memorial Sloan Kettering Nassau
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
  • Ohio
    • Akron, Ohio, United States, 44304
      • Summa Health System - Akron Campus
    • Belpre, Ohio, United States, 45714
      • Strecker Cancer Center-Belpre
    • Canton, Ohio, United States, 44710
      • Aultman Health Foundation
    • Chillicothe, Ohio, United States, 45601
      • Adena Regional Medical Center
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati Cancer Center-UC Medical Center
    • Cleveland, Ohio, United States, 44106
      • Case Western Reserve University
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
    • Cleveland, Ohio, United States, 44111
      • Cleveland Clinic Cancer Center/Fairview Hospital
    • Columbus, Ohio, United States, 43214
      • Riverside Methodist Hospital
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center
    • Columbus, Ohio, United States, 43219
      • The Mark H Zangmeister Center
    • Columbus, Ohio, United States, 43214
      • Columbus Oncology and Hematology Associates Inc
    • Columbus, Ohio, United States, 43228
      • Doctors Hospital
    • Columbus, Ohio, United States, 43213
      • Mount Carmel East Hospital
    • Columbus, Ohio, United States, 43215
      • Grant Medical Center
    • Columbus, Ohio, United States, 43222
      • Mount Carmel Health Center West
    • Dayton, Ohio, United States, 45405
      • Grandview Hospital
    • Delaware, Ohio, United States, 43015
      • Delaware Health Center-Grady Cancer Center
    • Delaware, Ohio, United States, 43015
      • Delaware Radiation Oncology
    • Delaware, Ohio, United States, 43015
      • Grady Memorial Hospital
    • Dublin, Ohio, United States, 43016
      • Dublin Methodist Hospital
    • Gahanna, Ohio, United States, 43230
      • Central Ohio Breast and Endocrine Surgery
    • Grove City, Ohio, United States, 43123
      • Mount Carmel Grove City Hospital
    • Lancaster, Ohio, United States, 43130
      • Fairfield Medical Center
    • Lima, Ohio, United States, 45801
      • Saint Rita's Medical Center
    • Mansfield, Ohio, United States, 44903
      • OhioHealth Mansfield Hospital
    • Marietta, Ohio, United States, 45750
      • Marietta Memorial Hospital
    • Marion, Ohio, United States, 43302
      • OhioHealth Marion General Hospital
    • Mayfield Heights, Ohio, United States, 44124
      • Hillcrest Hospital Cancer Center
    • Mentor, Ohio, United States, 44060
      • UH Seidman Cancer Center at Lake Health Mentor Campus
    • Mount Vernon, Ohio, United States, 43050
      • Knox Community Hospital
    • Newark, Ohio, United States, 43055
      • Licking Memorial Hospital
    • Newark, Ohio, United States, 43055
      • Newark Radiation Oncology
    • Perrysburg, Ohio, United States, 43551
      • Mercy Health Perrysburg Cancer Center
    • Portsmouth, Ohio, United States, 45662
      • Southern Ohio Medical Center
    • Sylvania, Ohio, United States, 43560
      • ProMedica Flower Hospital
    • Toledo, Ohio, United States, 43606
      • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
    • Toledo, Ohio, United States, 43608
      • Saint Vincent Mercy Medical Center
    • Toledo, Ohio, United States, 43623
      • Mercy Health - Saint Anne Hospital
    • Westerville, Ohio, United States, 43081
      • Saint Ann's Hospital
    • Zanesville, Ohio, United States, 43701
      • Genesis Healthcare System Cancer Care Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center
    • Tulsa, Oklahoma, United States, 74146
      • Oklahoma Cancer Specialists and Research Institute-Tulsa
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Jefferson Abington Hospital
    • Paoli, Pennsylvania, United States, 19301
      • Paoli Memorial Hospital
    • Willow Grove, Pennsylvania, United States, 19090
      • Asplundh Cancer Pavilion
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Medical Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Women and Infants Hospital
  • Texas
    • Dallas, Texas, United States, 75235
      • Parkland Memorial Hospital
    • Dallas, Texas, United States, 75390
      • UT Southwestern/Simmons Cancer Center-Dallas
    • Houston, Texas, United States, 77030
      • Memorial Hermann Texas Medical Center
  • Virginia
    • Portsmouth, Virginia, United States, 23708-2197
      • Naval Medical Center - Portsmouth
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University/Massey Cancer Center
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • Monongalia Hospital
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora Saint Luke's Medical Center
    • Mukwonago, Wisconsin, United States, 53149
      • ProHealth D N Greenwald Center
    • New Richmond, Wisconsin, United States, 54017
      • Cancer Center of Western Wisconsin
    • Oconomowoc, Wisconsin, United States, 53066
      • ProHealth Oconomowoc Memorial Hospital
    • Waukesha, Wisconsin, United States, 53188
      • UW Cancer Center at ProHealth Care
    • Waukesha, Wisconsin, United States, 53188
      • ProHealth Waukesha Memorial Hospital
    • West Allis, Wisconsin, United States, 53227
      • Aurora West Allis Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment (cone biopsy/lymphadenectomy or hysterectomy); Patients undergo cone biopsy and pelvic lymphadenectomy or simple hysterectomy and pelvic lymphadenectomy.

Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Procedure: Conization; Undergo cone biopsy; Other Names: cone biopsy; Cone Biopsy of Cervix; Conization of Cervix; Conization of Uterine Cervix; Procedure: Therapeutic Conventional Surgery; Undergo hysterectomy; Procedure: Therapeutic Lymphadenectomy; Undergo lymphadenectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Lymphedema	Based on Cancer Lymphedema Questionnaire score.	Up to 3 years
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Site of first recurrence	Classified as either local (pelvis regions, including vaginal) or distant (abdomen, lung, bone, brain, and other).	Up to 3 years
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
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

Collaborators and Investigators

• Sponsor: GOG Foundation
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Allan L Covens, NRG Oncology

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2013
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: July 21, 2012
• First Submitted That Met QC Criteria: July 21, 2012
• First Posted (Estimated): July 25, 2012

Study Record Updates

• Last Update Posted (Estimated): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Lymphatic Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Neoplasms, Complex and Mixed; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Uterine Cervical Neoplasms; Lymphedema; Carcinoma; Carcinoma, Adenosquamous
• Other Study ID Numbers: GOG-0278 (Other Identifier: CTEP); U10CA180868 (U.S. NIH Grant/Contract); UG1CA189867 (U.S. NIH Grant/Contract); U10CA101165 (U.S. NIH Grant/Contract); NCI-2012-01990 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); CDR0000737208