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 2015 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 17, 2015
Last verified: March 2015
  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 Carcinoma
Cervical Squamous Cell Carcinoma
Lymphedema
Sexual Dysfunction and Infertility
Stage IA Cervical Cancer
Stage IB Cervical Cancer
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Procedure: Conization
Procedure: Loop Electrosurgical Excision

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.
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Procedure: Conization
Undergo biopsy
Other Names:
  • Cone Biopsy of Cervix
  • Conization of Cervix
  • Conization of Uterine Cervix
Procedure: Loop Electrosurgical Excision
Undergo LEEP
Other Names:
  • LEEP
  • Loop Electrosurgical Excision
  • Loop Electrosurgical Excision Procedure

  Show Detailed Description

  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 116 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, UG1CA189867
Study First Received: July 21, 2012
Last Updated: March 17, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on March 30, 2015