Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01649089
Recruitment Status : Recruiting
First Posted : July 25, 2012
Last Update Posted : October 6, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
GOG Foundation

Tracking Information
First Submitted Date  ICMJE July 21, 2012
First Posted Date  ICMJE July 25, 2012
Last Update Posted Date October 6, 2021
Actual Study Start Date  ICMJE October 1, 2012
Estimated Primary Completion Date December 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2020)
  • 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 ]
    Analysis of variance methods with repeated measurements and a time component will initially be used to determine whether there are significant changes over time.
  • 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 [ Time Frame: Baseline to 3 years ]
    Analysis of variance methods with repeated measurements and a time component will initially be used to determine whether there are significant changes over time.
  • Lymphedema [ Time Frame: Up to 3 years ]
    Based on Cancer Lymphedema Questionnaire score.
  • Maximum grade and duration of severe adverse events associated with bladder, bowel, and sexual dysfunction and lymphedema [ Time Frame: Up to 3 years after non-radical surgical procedure ]
    Graded according to Common Terminology Criteria for Adverse Events version 4.0 (version 5.0 will be used staring April 1, 2018).
Original Primary Outcome Measures  ICMJE
 (submitted: July 21, 2012)
  • 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)
  • Sexual function and activity based on FSFI (19 items) score plus 2 PROMIS screener items
  • Lymphedema based on CLQ score
  • Maximum grade and duration of severe adverse events associated with bladder, bowel, and sexual dysfunction and lymphedema (LE) according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2020)
  • Maximum grade of treatment-related adverse events [ Time Frame: Up to 30 days after surgical procedure ]
    Graded according to Common Terminology Criteria for Adverse Events version 4.0 (version 5.0 will be used staring April 1, 2018).
  • Change in overall quality of life based on Functional Assessment of Cancer Therapy-Cervix (15 items) score [ Time Frame: Baseline to 3 years ]
    Analysis of variance methods with repeated measurements and a time component will initially be used to determine whether there are significant changes over time.
  • Change in cancer worries based on Impact of Events score [ Time Frame: Baseline to 3 years ]
    Analysis of variance methods with repeated measurements and a time component will initially be used to determine whether there are significant changes over time.
  • Change in reproductive concerns based on reproductive concerns (14 items) score [ Time Frame: Baseline to 3 years ]
    Analysis of variance methods with repeated measurements and a time component will initially be used to determine whether there are significant changes over time.
  • Site of first recurrence [ Time Frame: Up to 3 years ]
    Classified as either local (pelvis regions, including vaginal) or distant (abdomen, lung, bone, brain, and other).
  • Recurrence-free survival [ Time Frame: Up to 3 years ]
    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.
  • Overall survival [ Time Frame: Up to 3 years ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2012)
  • Maximum grade of treatment-related adverse events according to CTCAE v 4.0
  • Overall QOL based on FACT-Cx (15 items) score
  • Cancer worries based on IES score
  • Reproductive concerns based on RCS (14 items) score
  • Site of first recurrence, classified as either local (pelvis regions, including vaginal) or distant (abdomen, lung, bone, brain, and other) assessed up to 3 years
  • Recurrence-free survival assessed up to 3 years
  • Overall survival assessed up to 3 years
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Studying the Physical Function and Quality of Life Before and After Surgery in Patients With Stage I Cervical Cancer
Official Title  ICMJE 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
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Cervical Adenocarcinoma
  • Cervical Adenosquamous Carcinoma
  • Cervical Squamous Cell Carcinoma, Not Otherwise Specified
  • 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
Intervention  ICMJE
  • Procedure: Conization
    Undergo cone biopsy
    Other Names:
    • cone biopsy
    • Cone Biopsy of Cervix
    • Conization of Cervix
    • Conization of Uterine Cervix
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Name: Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
  • Procedure: Therapeutic Conventional Surgery
    Undergo hysterectomy
  • Procedure: Therapeutic Lymphadenectomy
    Undergo lymphadenectomy
Study Arms  ICMJE Experimental: Treatment (cone biopsy/lymphadenectomy or hysterectomy)
Patients undergo cone biopsy and pelvic lymphadenectomy or simple hysterectomy and pelvic lymphadenectomy.
Interventions:
  • Procedure: Conization
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
  • Procedure: Therapeutic Conventional Surgery
  • Procedure: Therapeutic Lymphadenectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 31, 2020)
220
Original Estimated Enrollment  ICMJE
 (submitted: July 21, 2012)
600
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Canada,   Korea, Republic of,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01649089
Other Study ID Numbers  ICMJE GOG-0278
NCI-2012-01990 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000737208
GOG-0278 ( Other Identifier: NRG Oncology )
GOG-0278 ( Other Identifier: DCP )
GOG-0278 ( Other Identifier: CTEP )
U10CA101165 ( U.S. NIH Grant/Contract )
U10CA180868 ( U.S. NIH Grant/Contract )
UG1CA189867 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GOG Foundation
Study Sponsor  ICMJE GOG Foundation
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Allan L Covens NRG Oncology
PRS Account GOG Foundation
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP