Trial record 16 of 248 for:    Open Studies | "Uterine Cervical Neoplasms"

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 March 2014 by Gynecologic Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01649089
First received: July 21, 2012
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

This 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 Cell Carcinoma
Cervical Squamous Cell Carcinoma
Lymphedema
Sexuality and Reproductive Issues
Stage IA Cervical Cancer
Stage IB Cervical Cancer
Procedure: quality-of-life assessment
Other: questionnaire administration
Procedure: cone biopsy
Procedure: loop electrosurgical excision procedure

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 ]
  • 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 ]
  • 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 (LE) 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:
  • 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 ]
  • Change in overall QOL based on FACT-Cx (15 items) score [ Time Frame: Baseline to 3 years ] [ Designated as safety issue: No ]
  • Change in cancer worries based on IES score [ Time Frame: Baseline to 3 years ] [ Designated as safety issue: No ]
  • Change in reproductive concerns based on RCS (14 items) score [ Time Frame: Baseline to 3 years ] [ Designated as safety issue: No ]
  • 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 ]
  • Recurrence-free survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Overall survival [ 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, LEEP)
Patients undergo cone biopsy with pelvic lymphadenectomy or simple hysterectomy with pelvic lymphadenectomy.
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: questionnaire administration
Ancillary studies
Procedure: cone biopsy
Undergo biopsy
Other Names:
  • Cone Biopsy of Cervix
  • Conization
  • Conization of Cervix
  • Conization of Uterine Cervix
Procedure: loop electrosurgical excision procedure
Undergo LEEP
Other Names:
  • LEEP
  • Loop Electrosurgical Excision

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 (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 (lymphatic vessel invasion [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 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 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: 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.

  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 (loop electrosurgical excision [LEEP]) and had negative margins for carcinoma and high-grade dysplasia; depth of invasion must be =< 10 mm
  • Patients must have no evidence of metastasis on 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 > 10mm 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 80 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Allan Covens Gynecologic Oncology Group
  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
Study First Received: July 21, 2012
Last Updated: March 25, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 31, 2014