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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Gynecologic Oncology Group
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01649089
First received: July 21, 2012
Last updated: February 9, 2016
Last verified: February 2016
  Purpose
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.

Condition Intervention
Cervical Adenocarcinoma
Cervical Adenosquamous Carcinoma
Cervical Squamous Cell Carcinoma
Lymphedema
Sexual Dysfunction and Infertility
Stage IA1 Cervical Cancer
Stage IA2 Cervical Cancer
Stage IB1 Cervical Cancer
Procedure: Conization
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Procedure: Therapeutic Conventional Surgery
Procedure: Therapeutic Lymphadenectomy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Change in 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) [ Time Frame: Baseline to 3 years ] [ Designated as safety issue: No ]
    Analysis of variance (ANOVA) 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 FSFI (19 items) score plus 2 PROMIS screener items [ Time Frame: Baseline to 3 years ] [ Designated as safety issue: No ]
    ANOVA methods with repeated measurements and a time component will initially be used to determine whether there are significant changes over time.

  • Lymphedema based on CLQ score [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Maximum grade and duration of severe adverse events associated with bladder, bowel, and sexual dysfunction and lymphedema according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 3 years after non-radical surgical procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in cancer worries based on IES score [ Time Frame: Baseline to 3 years ] [ Designated as safety issue: No ]
    ANOVA methods with repeated measurements and a time component will initially be used to determine whether there are significant changes over time.

  • Change in overall QOL based on FACT-Cx (15 items) score [ Time Frame: Baseline to 3 years ] [ Designated as safety issue: No ]
    ANOVA 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 RCS (14 items) score [ Time Frame: Baseline to 3 years ] [ Designated as safety issue: No ]
    ANOVA methods with repeated measurements and a time component will initially be used to determine whether there are significant changes over time.

  • Maximum grade of treatment-related adverse events according to CTCAE v 4.0 [ Time Frame: Up to 30 days after surgical procedure ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Product-limit estimates according to the method of Kaplan and Meier will be used to estimate OS. In addition, CPH 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.

  • Recurrence-free survival (RFS) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Product-limit estimates according to the method of Kaplan and Meier will be used to estimate RFS. In addition, Cox proportional hazard (CPH) 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.

  • Site of first recurrence, classified as either local (pelvis regions, including vaginal) or distant (abdomen, lung, bone, brain, and other) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: October 2012
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (cone biopsy/lymphadenectomy or hysterectomy)
Patients undergo cone biopsy and pelvic lymphadenectomy or simple hysterectomy and pelvic lymphadenectomy.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01649089

  Show 136 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Allan Covens NRG Oncology
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01649089     History of Changes
Other Study ID Numbers: GOG-0278  NCI-2012-01990  CDR0000737208  GOG-0278  GOG-0278  GOG-0278  U10CA101165  UG1CA189867 
Study First Received: July 21, 2012
Last Updated: February 9, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Carcinoma, Adenosquamous
Carcinoma, Squamous Cell
Lymphedema
Uterine Cervical Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Lymphatic Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Complex and Mixed
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms

ClinicalTrials.gov processed this record on February 09, 2016