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

• ClinicalTrials.gov Identifier: NCT01649089
• Recruitment Status: Active, not recruiting
• First Posted: July 25, 2012
• Last Update Posted: May 3, 2024
• Sponsor: GOG Foundation
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): GOG Foundation

Tracking Information

• First Submitted Date: July 21, 2012
• First Posted Date: July 25, 2012
• Last Update Posted Date: May 3, 2024
• Actual Study Start Date: June 5, 2013
• Estimated Primary Completion Date: December 1, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

Current Secondary Outcome Measures (submitted: August 10, 2022)

• 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 [ Time Frame: Baseline to 3 years ]
  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.
• 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 (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: Studying the Physical Function and Quality of Life Before and After Surgery in Patients With Stage I Cervical Cancer
• 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

• Cervical Adenocarcinoma
• Cervical Adenosquamous Carcinoma
• Cervical Squamous Cell Carcinoma
• 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

• 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

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

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: August 10, 2022): 224
• Original Estimated Enrollment (submitted: July 21, 2012): 600
• Estimated Study Completion Date: December 1, 2025
• Estimated Primary Completion Date: December 1, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, Korea, Republic of, United States

Administrative Information

• NCT Number: NCT01649089
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: GOG Foundation
• Original Responsible Party: Philip J. DiSaia, Gynecologic Oncology Group
• Current Study Sponsor: GOG Foundation
• Original Study Sponsor: Gynecologic Oncology Group
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Allan L Covens; NRG Oncology

• PRS Account: GOG Foundation
• Verification Date: May 2024