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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


N/A
18 Years
N/A
Open (Enrolling)
Female
Cervical Cancer, Lymphedema, Sexuality and Reproductive Issues

Thank you

Trial Information

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


OBJECTIVES:

Primary

- 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 (LVSI+) and
IA2-IB1 (< 2 cm) carcinoma of the cervix.

- To evaluate incidence and severity of lymphedema after non-radical surgery (simple
hysterectomy or cone biopsy [fertility preservation] and pelvic lymphadenectomy) for
stage IA1 (lymphatic vessel invasion [LVSI]+) and IA2-IB1 (< 2 cm) carcinoma of the
cervix.

Secondary

- 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).

- To evaluate incidence and severity of treatment-related adverse events, including
surgical complications, among the entire cohort and by treatment type.

- 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.

- To explore relationships (correlation, interaction, independence) between functional
outcomes (i.e., bladder function, bowel function, sexual function), adverse events
(including surgical complication lymphedema [Gynecologic Cancer Lymphedema
Questionnaire {GCLQ}]), cancer worry (IES), surgical complications, and overall quality
of life (FACT-Cx).

- To determine participants' intention for conception & fertility rates (Integrative Care
for Fertility [ICF]) and assess the RCS of women following cone biopsy and pelvic
lymphadenectomy for stage IA1 (LVSI+) and IA2-IB1 (< 2 cm) carcinoma of the cervix.

- 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: This is a multicenter study.

Patients are stratified according to their fertility wishes (cone biopsy and pelvic
lymphadenectomy [fertility preservation] vs simple hysterectomy and pelvic lymphadenectomy
[fertility preservation not desired]).

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

Patients in both groups 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 in group 1 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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Patients with a histologic diagnosis of squamous cell carcinoma, adenocarcinoma, or
adenosquamous cell carcinoma of the cervix, stage IA1 (LVSI+), IA2, and IB1 (tumor
size [maximum visible or palpable]) ≤ 2 cm), any grade

- No patients with stage IA1 disease who are LVSI negative

- No patients with stage IB1 with tumor size (maximum visible or palpable) > 2 cm

- No patients with ≥ stage IB2 disease

- All patients must have undergone a cone biopsy or loop electrosurgical excision
procedure (LEEP) and had negative margins for carcinoma and high-grade dysplasia;
depth of invasion must be ≤ 10 mm

- The maximum depth of invasion will be calculated by summing the two cone
biopsies if the lateral margins were positive on the first cone biopsy; if the
sum is > 10mm, the patient is ineligible

- For hysterectomy patients: If positive lateral margins (i.e., depth), then
another cone or LEEP biopsy needs to be performed preoperatively for simple
hysterectomy patients; the maximum depth of invasion will be calculated by
summing the two cone biopsies if the lateral margins were positive on the first
cone biopsy; for cone biopsy patients: If margins were positive, a repeat cone
biopsy (positive endocervical curettage [+ECC]) is required and should be
performed at the time of pelvic lymphadenectomy

- Patients must have no evidence of metastasis on magnetic resonance imaging (MRI) or
computed tomography (CT) scan of the pelvis and chest

- Patients must have negative pelvic lymph nodes on final pathology

- No patients with clear cell or neuroendocrine cell types

PATIENT CHARACTERISTICS:

- Patient must consent for the appropriate surgery

- 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

- 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

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No patients requiring adjuvant therapy post-operatively

- Patients are excluded if their previous cancer treatment contraindicates this
protocol therapy

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Bladder and bowel function score based on supplemental bladder and bowel (SBB) questions plus 4 items from the FACT-Cx (3 bladder and 1 bowel question)

Safety Issue:

No

Principal Investigator

Allan Covens, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Odette Cancer Centre at Sunnybrook

Authority:

United States: National Cancer Institute

Study ID:

GOG-0278

NCT ID:

NCT01649089

Start Date:

October 2012

Completion Date:

Related Keywords:

  • Cervical Cancer
  • Lymphedema
  • Sexuality and Reproductive Issues
  • sexuality and reproductive issues
  • lymphedema
  • cervical adenocarcinoma
  • cervical adenosquamous cell carcinoma
  • cervical squamous cell carcinoma
  • stage IA cervical cancer
  • stage IB cervical cancer
  • Uterine Cervical Neoplasms
  • Lymphedema

Name

Location

Cleveland Clinic FoundationCleveland, Ohio  44195
Fairview Ridges HospitalBurnsville, Minnesota  55337
Hutchinson Area Health CareHutchinson, Minnesota  55350
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Via Christi Regional Medical CenterWichita, Kansas  67214
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Cancer Center of Kansas - ChanuteChanute, Kansas  66720
Cancer Center of Kansas - Dodge CityDodge City, Kansas  67801
Cancer Center of Kansas - NewtonNewton, Kansas  67114
Cancer Center of Kansas - SalinaSalina, Kansas  67042
Cancer Center of Kansas - WellingtonWellington, Kansas  67152
Associates in Womens HealthWichita, Kansas  67203
Cancer Center of Kansas - WinfieldWinfield, Kansas  67156
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
Mercy HospitalCoon Rapids, Minnesota  55433
Fairview-Southdale HospitalEdina, Minnesota  55435
Abbott-Northwestern HospitalMinneapolis, Minnesota  55407
Regions HospitalSaint Paul, Minnesota  55101
Saint Francis Regional Medical CenterShakopee, Minnesota  55379
Rice Memorial HospitalWillmar, Minnesota  56201
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Hennepin County Medical CenterMinneapolis, Minnesota  
Case Western Reserve UniversityCleveland, Ohio  44106
Wichita CCOPWichita, Kansas  67214-3882
Metro-Minnesota CCOPSt. Louis Park, Minnesota  
Lakeview HospitalStillwater, Minnesota  55082
Lankenau HospitalWynnewood, Pennsylvania  19096
Florida HospitalOrlando, Florida  32803
Hillcrest Hospital Cancer CenterMayfield Heights, Ohio  44124
New Ulm Medical CenterNew Ulm, Minnesota  56073
Cancer Center of Kansas - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas-KingmanKingman, Kansas  67068
Cancer Center of Kansas - ParsonsParsons, Kansas  67357
Cancer Center of Kansas - PrattPratt, Kansas  67124
Cancer Center of Kansas-Wichita Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas - Main OfficeWichita, Kansas  67214
Unity HospitalFridley, Minnesota  55432
Saint John's Hospital - HealtheastMaplewood, Minnesota  55109
Minnesota Oncology Hematology PA-MaplewoodMaplewood, Minnesota  55109
North Memorial Medical Health CenterRobbinsdale, Minnesota  55422
Park Nicollet Clinic - Saint Louis ParkSaint Louis Park, Minnesota  55416
Minnesota Oncology and Hematology PA-WoodburyWoodbury, Minnesota  55125
Ozark Health Ventures LLC dba Cancer Research for The Ozarks SpringfieldSpringfield, Missouri  65802
Saint John's HospitalSpringfield, Missouri  65804
Cox Medical CenterSpringfield, Missouri  65807
Cancer Care Associates-YaleTulsa, Oklahoma  74136-1929
Women and Infants HospitalProvidence, Rhode Island  02905
Lake University Ireland Cancer CenterMentor, Ohio  44060
Cancer Center of Kansas-LiberalLiberal, Kansas  67901
Olive View-University of California Los Angeles Medical CenterSylmar, California  91342
Aurora Women's Pavilion of Aurora West Allis Medical CenterWest Allis, Wisconsin  53227
Women's Cancer Center of NevadaLas Vegas, Nevada  89109
Sudarshan K Sharma MD Limted-Gynecologic OncologyHinsdale, Illinois  60521
Aurora Saint Luke's Medical CenterMilwaukee, Wisconsin  53215
Summa Akron City HospitalAkron, Ohio  44304
Gynecologic Oncology GroupPhiladelphia, Pennsylvania  19103
Cleveland Clinic Cancer Center/Fairview HospitalCleveland, Ohio  44111
Saint Joseph's Hospital and Medical CenterPhoenix, Arizona  85013
Cancer Center of Western WisconsinNew Richmond, Wisconsin  54017
Memorial Hermann Texas Medical CenterHouston, Texas  77030