Studying the Physical Function and Quality of Life Before and After Surgery in Patients With Stage I Cervical Cancer
NCT ID: NCT01649089
Last Updated: 2024-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
224 participants
INTERVENTIONAL
2013-06-05
2025-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Treatment (cone biopsy/lymphadenectomy or hysterectomy)
Patients undergo cone biopsy and pelvic lymphadenectomy or simple hysterectomy and pelvic lymphadenectomy.
Conization
Undergo cone biopsy
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Therapeutic Conventional Surgery
Undergo hysterectomy
Therapeutic Lymphadenectomy
Undergo lymphadenectomy
Interventions
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Conization
Undergo cone biopsy
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Therapeutic Conventional Surgery
Undergo hysterectomy
Therapeutic Lymphadenectomy
Undergo lymphadenectomy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
GOG Foundation
NETWORK
Responsible Party
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Principal Investigators
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Allan L Covens
Role: PRINCIPAL_INVESTIGATOR
NRG Oncology
Locations
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Cancer Center at Saint Joseph's
Phoenix, Arizona, United States
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Sutter Auburn Faith Hospital
Auburn, California, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States
Mills-Peninsula Medical Center
Burlingame, California, United States
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, United States
Eden Hospital Medical Center
Castro Valley, California, United States
Sutter Davis Hospital
Davis, California, United States
Palo Alto Medical Foundation-Fremont
Fremont, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Memorial Medical Center
Modesto, California, United States
Palo Alto Medical Foundation-Camino Division
Mountain View, California, United States
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States
Palo Alto Medical Foundation Health Care
Palo Alto, California, 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
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
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California, United States
Olive View-University of California Los Angeles Medical Center
Sylmar, California, United States
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Vacaville, California, United States
Sutter Solano Medical Center/Cancer Center
Vallejo, California, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 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
AdventHealth Orlando
Orlando, Florida, United States
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, United States
Queen's Medical Center
Honolulu, Hawaii, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, United States
Sudarshan K Sharma MD Limited-Gynecologic Oncology
Hinsdale, Illinois, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States
Cancer Center of Kansas-Independence
Independence, Kansas, United States
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States
Lawrence Memorial Hospital
Lawrence, Kansas, United States
Cancer Center of Kansas-Liberal
Liberal, Kansas, United States
Cancer Center of Kansas-Manhattan
Manhattan, Kansas, United States
Cancer Center of Kansas - McPherson
McPherson, Kansas, United States
Cancer Center of Kansas - Newton
Newton, Kansas, United States
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States
Cancer Center of Kansas - Salina
Salina, Kansas, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States
Associates In Womens Health
Wichita, Kansas, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States
Ascension Via Christi Hospitals Wichita
Wichita, Kansas, United States
Cancer Center of Kansas - Wichita
Wichita, Kansas, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States
Baptist Health Corbin
Corbin, Kentucky, United States
Baptist Health Lexington
Lexington, Kentucky, United States
Baptist Health Madisonville/Merle Mahr Cancer Center
Madisonville, Kentucky, United States
Baptist Health Paducah
Paducah, Kentucky, United States
Hematology/Oncology Clinic PLLC
Baton Rouge, Louisiana, United States
Woman's Hospital
Baton Rouge, Louisiana, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Fairview Ridges Hospital
Burnsville, Minnesota, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Fairview Southdale Hospital
Edina, Minnesota, United States
Unity Hospital
Fridley, Minnesota, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, 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
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Health Partners Inc
Minneapolis, Minnesota, United States
New Ulm Medical Center
New Ulm, Minnesota, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 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
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States
Lakeview Hospital
Stillwater, Minnesota, United States
Ridgeview Medical Center
Waconia, Minnesota, United States
Rice Memorial Hospital
Willmar, Minnesota, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, United States
Fairview Lakes Medical Center
Wyoming, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Mercy Hospital Joplin
Joplin, Missouri, United States
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
CoxHealth South Hospital
Springfield, Missouri, United States
Saint Louis Cancer and Breast Institute-South City
St Louis, Missouri, United States
Mercy Hospital Saint Louis
St Louis, Missouri, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States
Cooper Hospital University Medical Center
Camden, New Jersey, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States
MD Anderson Cancer Center at Cooper-Voorhees
Voorhees Township, New Jersey, United States
Memorial Sloan Kettering Commack
Commack, New York, United States
Memorial Sloan Kettering Westchester
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Summa Health System - Akron Campus
Akron, Ohio, United States
Strecker Cancer Center-Belpre
Belpre, Ohio, United States
Aultman Health Foundation
Canton, Ohio, 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
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Mount Carmel East Hospital
Columbus, Ohio, United States
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Grant Medical Center
Columbus, Ohio, United States
The Mark H Zangmeister Center
Columbus, Ohio, United States
Mount Carmel Health Center West
Columbus, Ohio, United States
Doctors Hospital
Columbus, Ohio, United States
Grandview Hospital
Dayton, Ohio, 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
Dublin Methodist Hospital
Dublin, Ohio, United States
Central Ohio Breast and Endocrine Surgery
Gahanna, Ohio, United States
Mount Carmel Grove City Hospital
Grove City, Ohio, United States
Fairfield Medical Center
Lancaster, Ohio, United States
Saint Rita's Medical Center
Lima, Ohio, United States
OhioHealth Mansfield Hospital
Mansfield, Ohio, 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
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio, United States
Knox Community Hospital
Mount Vernon, Ohio, United States
Licking Memorial Hospital
Newark, Ohio, United States
Newark Radiation Oncology
Newark, Ohio, United States
Mercy Health Perrysburg Cancer Center
Perrysburg, Ohio, United States
Southern Ohio Medical Center
Portsmouth, Ohio, United States
ProMedica Flower Hospital
Sylvania, 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
Mercy Health - Saint Anne Hospital
Toledo, Ohio, United States
Saint Ann's Hospital
Westerville, Ohio, United States
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, United States
Jefferson Abington Hospital
Abington, Pennsylvania, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, United States
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
Women and Infants Hospital
Providence, Rhode Island, United States
Parkland Memorial Hospital
Dallas, Texas, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States
Memorial Hermann Texas Medical Center
Houston, Texas, United States
Naval Medical Center - Portsmouth
Portsmouth, Virginia, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States
Monongalia Hospital
Morgantown, West Virginia, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, United States
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Samsung Medical Center
Seoul, Korea, South Korea
Catholic University of Korea-Seoul Saint Mary's Hospital
Seoul, Korea, South Korea
Seoul National University Bundang Hospital
Seongnam, Kyeonggi-do, South Korea
Gachon University Gil Hospital
Incheon, , South Korea
Asan Medical Center
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Yonsei University Health System-Severance Hospital
Seoul, , South Korea
Kyung Hee University Hospital at Gangdong
Seoul, , South Korea
Korea Cancer Center Hospital
Seoul, , South Korea
Countries
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References
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Boisen M, Guido R. Emerging Treatment Options for Cervical Dysplasia and Early Cervical Cancer. Clin Obstet Gynecol. 2023 Sep 1;66(3):500-515. doi: 10.1097/GRF.0000000000000790. Epub 2023 Jul 25.
Other Identifiers
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NCI-2012-01990
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000737208
Identifier Type: -
Identifier Source: secondary_id
GOG-0278
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0278
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0278
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0278
Identifier Type: -
Identifier Source: org_study_id
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