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Cervical AdenocarcinomaNCT01649089

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

A study testing Conization, Quality-of-Life Assessment and Questionnaire Administration in people with Cervical Adenocarcinoma and Cervical Adenosquamous Carcinoma, run by GOG Foundation at 185 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Conization, Quality-of-Life Assessment and Questionnaire Administration
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
224 participants
Where
185 sitesin 3 countries
Study dates
5 Jun 2013to 1 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

185 sites in 3 countries.

185 sites in 3 countries

United States174 sites

  • Jefferson Abington Hospital

    Abington, Pennsylvania, 19001

  • Summa Health System - Akron Campus

    Akron, Ohio, 44304

  • Sutter Auburn Faith Hospital

    Auburn, California, 95602

  • Sutter Cancer Centers Radiation Oncology Services-Auburn

    Auburn, California, 95603

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Hematology/Oncology Clinic PLLC

    Baton Rouge, Louisiana, 70809

  • Woman's Hospital

    Baton Rouge, Louisiana, 70817

  • Strecker Cancer Center-Belpre

    Belpre, Ohio, 45714

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, 94704

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Mills-Peninsula Medical Center

    Burlingame, California, 94010

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Sutter Cancer Centers Radiation Oncology Services-Cameron Park

    Cameron Park, California, 95682

  • Aultman Health Foundation

    Canton, Ohio, 44710

  • Eden Hospital Medical Center

    Castro Valley, California, 94546

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohio, 45219

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Mount Carmel East Hospital

    Columbus, Ohio, 43213

  • Columbus Oncology and Hematology Associates Inc

    Columbus, Ohio, 43214

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Grant Medical Center

    Columbus, Ohio, 43215

  • The Mark H Zangmeister Center

    Columbus, Ohio, 43219

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

  • Doctors Hospital

    Columbus, Ohio, 43228

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Baptist Health Corbin

    Corbin, Kentucky, 40701

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Sutter Davis Hospital

    Davis, California, 95616

  • Grandview Hospital

    Dayton, Ohio, 45405

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442

  • Delaware Health Center-Grady Cancer Center

    Delaware, Ohio, 43015

  • Delaware Radiation Oncology

    Delaware, Ohio, 43015

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Dublin Methodist Hospital

    Dublin, Ohio, 43016

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Palo Alto Medical Foundation-Fremont

    Fremont, California, 94538

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Central Ohio Breast and Endocrine Surgery

    Gahanna, Ohio, 43230

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

  • Mount Carmel Grove City Hospital

    Grove City, Ohio, 43123

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • Sudarshan K Sharma MD Limited-Gynecologic Oncology

    Hinsdale, Illinois, 60521

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • Memorial Hermann Texas Medical Center

    Houston, Texas, 77030

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Mercy Hospital Joplin

    Joplin, Missouri, 64804

  • Cancer Center of Kansas-Kingman

    Kingman, Kansas, 67068

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Women's Cancer Center of Nevada

    Las Vegas, Nevada, 89106

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • Cancer Center of Kansas-Liberal

    Liberal, Kansas, 67905

  • Saint Rita's Medical Center

    Lima, Ohio, 45801

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Baptist Health Madisonville/Merle Mahr Cancer Center

    Madisonville, Kentucky, 42431

  • Cancer Center of Kansas-Manhattan

    Manhattan, Kansas, 66502

  • OhioHealth Mansfield Hospital

    Mansfield, Ohio, 44903

  • Fairview Clinics and Surgery Center Maple Grove

    Maple Grove, Minnesota, 55369

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • OhioHealth Marion General Hospital

    Marion, Ohio, 43302

  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio, 44124

  • Cancer Center of Kansas - McPherson

    McPherson, Kansas, 67460

  • UH Seidman Cancer Center at Lake Health Mentor Campus

    Mentor, Ohio, 44060

  • Jackson Memorial Hospital-Holtz Children's Hospital

    Miami, Florida, 33136

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Health Partners Inc

    Minneapolis, Minnesota, 55454

  • Memorial Medical Center

    Modesto, California, 95355

  • Monongalia Hospital

    Morgantown, West Virginia, 26505

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • Knox Community Hospital

    Mount Vernon, Ohio, 43050

  • Palo Alto Medical Foundation-Camino Division

    Mountain View, California, 94040

  • Palo Alto Medical Foundation-Gynecologic Oncology

    Mountain View, California, 94040

  • ProHealth D N Greenwald Center

    Mukwonago, Wisconsin, 53149

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112

  • Cancer Center of Western Wisconsin

    New Richmond, Wisconsin, 54017

  • New Ulm Medical Center

    New Ulm, Minnesota, 56073

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Licking Memorial Hospital

    Newark, Ohio, 43055

  • Newark Radiation Oncology

    Newark, Ohio, 43055

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

  • ProHealth Oconomowoc Memorial Hospital

    Oconomowoc, Wisconsin, 53066

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • AdventHealth Orlando

    Orlando, Florida, 32803

  • Baptist Health Paducah

    Paducah, Kentucky, 42003

  • Palo Alto Medical Foundation Health Care

    Palo Alto, California, 94301

  • Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301

  • Cancer Center of Kansas - Parsons

    Parsons, Kansas, 67357

  • Mercy Health Perrysburg Cancer Center

    Perrysburg, Ohio, 43551

  • Cancer Center at Saint Joseph's

    Phoenix, Arizona, 85004

  • Saint Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013

  • UM Sylvester Comprehensive Cancer Center at Plantation

    Plantation, Florida, 33324

  • Southern Ohio Medical Center

    Portsmouth, Ohio, 45662

  • Naval Medical Center - Portsmouth

    Portsmouth, Virginia, 23708-2197

  • Cancer Center of Kansas - Pratt

    Pratt, Kansas, 67124

  • Women and Infants Hospital

    Providence, Rhode Island, 02905

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia, 23298

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • University of Rochester

    Rochester, New York, 14642

  • Mercy Clinic-Rolla-Cancer and Hematology

    Rolla, Missouri, 65401

  • Sutter Cancer Centers Radiation Oncology Services-Roseville

    Roseville, California, 95661

  • Sutter Roseville Medical Center

    Roseville, California, 95661

  • Sutter Medical Center Sacramento

    Sacramento, California, 95816

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67401

  • California Pacific Medical Center-Pacific Campus

    San Francisco, California, 94115

  • Palo Alto Medical Foundation-Santa Cruz

    Santa Cruz, California, 95065

  • Sutter Pacific Medical Foundation

    Santa Rosa, California, 95403

  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

    Savannah, Georgia, 31405

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • Saint Louis Cancer and Breast Institute-South City

    St Louis, Missouri, 63109

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

  • Lakeview Hospital

    Stillwater, Minnesota, 55082

  • Palo Alto Medical Foundation-Sunnyvale

    Sunnyvale, California, 94086

  • Olive View-University of California Los Angeles Medical Center

    Sylmar, California, 91342

  • ProMedica Flower Hospital

    Sylvania, Ohio, 43560

  • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

    Toledo, Ohio, 43606

  • Saint Vincent Mercy Medical Center

    Toledo, Ohio, 43608

  • Mercy Health - Saint Anne Hospital

    Toledo, Ohio, 43623

  • Oklahoma Cancer Specialists and Research Institute-Tulsa

    Tulsa, Oklahoma, 74146

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553

  • Sutter Cancer Centers Radiation Oncology Services-Vacaville

    Vacaville, California, 95687

  • Sutter Solano Medical Center/Cancer Center

    Vallejo, California, 94589

  • MD Anderson Cancer Center at Cooper-Voorhees

    Voorhees Township, New Jersey, 08043

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, 60555

  • ProHealth Waukesha Memorial Hospital

    Waukesha, Wisconsin, 53188

  • UW Cancer Center at ProHealth Care

    Waukesha, Wisconsin, 53188

  • Cancer Center of Kansas - Wellington

    Wellington, Kansas, 67152

  • Aurora West Allis Medical Center

    West Allis, Wisconsin, 53227

  • Saint Ann's Hospital

    Westerville, Ohio, 43081

  • Associates In Womens Health

    Wichita, Kansas, 67208

  • Cancer Center of Kansas-Wichita Medical Arts Tower

    Wichita, Kansas, 67208

  • Ascension Via Christi Hospitals Wichita

    Wichita, Kansas, 67214

  • Cancer Center of Kansas - Wichita

    Wichita, Kansas, 67214

  • Rice Memorial Hospital

    Willmar, Minnesota, 56201

  • Asplundh Cancer Pavilion

    Willow Grove, Pennsylvania, 19090

  • Cancer Center of Kansas - Winfield

    Winfield, Kansas, 67156

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • Minnesota Oncology Hematology PA-Woodbury

    Woodbury, Minnesota, 55125

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096

  • Fairview Lakes Medical Center

    Wyoming, Minnesota, 55092

  • Genesis Healthcare System Cancer Care Center

    Zanesville, Ohio, 43701

Other trials in United States

South Korea10 sites

  • Gachon University Gil Hospital

    Incheon, 405-760

  • Seoul National University Bundang Hospital

    Seongnam, Kyeonggi-do, 463-707

  • Samsung Medical Center

    Seoul, Korea, 135-710

  • Catholic University of Korea-Seoul Saint Mary's Hospital

    Seoul, Korea, 137-040

  • Asan Medical Center

    Seoul, 05505

  • Gangnam Severance Hospital

    Seoul, 06273

  • Seoul National University Hospital

    Seoul, 110-744

  • Yonsei University Health System-Severance Hospital

    Seoul, 120-752

  • Kyung Hee University Hospital at Gangdong

    Seoul, 134-727

  • Korea Cancer Center Hospital

    Seoul, 139-706

Other trials in South Korea

Canada1 site

  • Odette Cancer Centre- Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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).

  1. 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.

Being tested
Conization, Quality-of-Life Assessment, Questionnaire Administration, Therapeutic Conventional Surgery, Therapeutic Lymphadenectomy
Medical subject headings
Lymphedema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ConizationProcedure or surgery

    Also called cone biopsy, Cone Biopsy of Cervix, Conization of Cervix, Conization of Uterine Cervix

    Undergo cone biopsy

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • Therapeutic Conventional SurgeryProcedure or surgery

    Undergo hysterectomy

  • Therapeutic LymphadenectomyProcedure or surgery

    Undergo lymphadenectomy

Study groups in NCT01649089
Study groupRoleWhat they receive
Treatment (cone biopsy/lymphadenectomy or hysterectomy)ExperimentalPatients undergo cone biopsy and pelvic lymphadenectomy or simple hysterectomy and pelvic lymphadenectomy.
Receives: Procedure: Conization; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Therapeutic Conventional Surgery; Procedure: Therapeutic Lymphadenectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to 3 years

  2. 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.

    Measured: Baseline to 3 years

  3. Lymphedema

    Based on Cancer Lymphedema Questionnaire score.

    Measured: Up to 3 years

  4. 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).

    Measured: Up to 3 years after non-radical surgical procedure

Secondary outcomes (7)

  1. 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).

    Measured: Up to 30 days after surgical procedure

  2. 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.

    Measured: Baseline to 3 years

  3. 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.

    Measured: Baseline to 3 years

  4. 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.

    Measured: Baseline to 3 years

  5. Site of first recurrence

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

    Measured: Up to 3 years

  6. 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.

    Measured: Up to 3 years

  7. 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.

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2012 (estimated)
  2. Study start5 Jun 2013
  3. Primary completion1 Dec 2024 (estimated)
  4. Study completion1 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
224 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01649089
Sponsor's protocol ID
GOG-0278
Other IDs
NCI-2012-01990, CDR0000737208, GOG-0278, GOG-0278, GOG-0278, U10CA101165, U10CA180868, UG1CA189867
Status last verified
May 2024
First submitted
21 Jul 2012
Last updated
3 May 2024
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 37650664

Questions about this trial

What is this clinical trial studying?

A study testing Conization, Quality-of-Life Assessment and Questionnaire Administration in people with Cervical Adenocarcinoma and Cervical Adenosquamous Carcinoma, run by GOG Foundation at 185 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 185 sites in United States, South Korea, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: Baseline to 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01649089, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.

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