Pelvic Exenteration for Gynecologic Malignancy - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00791635

Purpose

Primary Objectives

To determine the types of complications experienced by women who undergo pelvic exenteration at UT MD Anderson Cancer Center.
To determine whether the number of complications experienced by women who undergo pelvic exenteration at UT MD Anderson Cancer Center differ by vaginal and bladder reconstruction types.

Secondary Objectives

To evaluate pathologic predictors of recurrence including histology, size of tumor, and distance of closest margin.
To longitudinally assess quality of life, sexual functioning, and symptoms in women who have undergone pelvic exenteration for gynecologic malignancies. This study will focus on quality of life issues specific to vaginal and bladder reconstruction.
To assess the impact of certain preoperative factors (albumin, electrolyte levels, body mass index) on the occurrence of post-operative complications.
To determine if preoperative PET/CT correlates with pathologic findings at the time of surgery.
To calculate time to recurrence, overall survival, and disease-free survival of patients who undergo pelvic exenteration and correlate to key demographic, clinical, and pathologic factors.

Condition	Intervention
Cervical Cancer Endometrial Cancer Vaginal Cancer Vulvar Cancer Gynecologic Cancer	Behavioral: Questionnaires

MedlinePlus related topics: Cancer Vaginal Cancer Vulvar Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Longitudinal Evaluation of Women Undergoing Pelvic Exenteration for Treatment of Gynecologic Malignancy

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To learn if certain characteristics of gynecological cancer can help researchers predict how well a patient recovers from pelvic exenteration surgery. [ Time Frame: 4 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare the types of surgery completed and procedures used to find out which are most effective and safe and to study how the surgery affected quality of life. [ Time Frame: 4 Years ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	200
Study Start Date:	September 2008
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Prospective: Questionnaires Prior to Scheduled Pelvic Exenteration Surgery.	Behavioral: Questionnaires 11 Questionnaires
2 Retrospective: Questionnaires Post Pelvic Exenteration Surgery.	Behavioral: Questionnaires 11 Questionnaires

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Women having gynecological cancer that was either treated with or will be treated with pelvic exenteration surgery.

Criteria

Inclusion Criteria:

Women with a history of gynecologic malignancy, including cervical, endometrial, vulvar, or vaginal carcinoma of any histology.
Women who have undergone a pelvic exenteration after January 1993 or who are being offered a pelvic exenteration for treatment of their gynecologic malignancy.
Patients must be suitable candidates fo surgery (in case of prospective collection).
Patients who have signed an approved Informed Consent.
Patients with a prior malignancy allowed if > 3 years previous with no current evidence of disease.
Females older than 18 years.
Women must be able to read and write in either Spanish or English.

Exclusion Criteria:

Patients with contraindications to surgery.
Patients unwilling or unable to complete self-administered questionnaires.
Patients who do not read or speak English or Spanish.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00791635

Contacts

Contact: Pamela Soliman, MD

713-745-2352

Locations

United States, Texas
UT MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Pamela Soliman, MD
St. Luke's Episcopal Hospital	Not yet recruiting
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Pamela Soliman, MD

UT MD Anderson Cancer Center

More Information

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

Responsible Party:	UT MD Anderson Cancer Center ( Pamela Soliman, MD/Assistant Professor )
Study ID Numbers:	2008-0095
Study First Received:	November 13, 2008
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00791635
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Cervical Cancer
Vaginal Cancer
Endometrial Cancer
Cervix
Endometrial
Pelvic Exenteration

Pelvic Exenteration Surgery
Questionnaire
Gynecologic Cancer
Vagina
Vulva
Gynecologic Malignancy

Study placed in the following topic categories:

Vaginal Neoplasms
Genital Neoplasms, Female
Uterine Diseases
Vaginal cancer
Urogenital Neoplasms
Vaginal Diseases
Genital Diseases, Female

Endometrial Neoplasms
Vulvar Neoplasms
Uterine Neoplasms
Endometrial cancer
Vulvar Diseases
Vulvar cancer

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009