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Longitudinal Evaluation of Women Undergoing Pelvic Surgery for the Treatment of Gynecologic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00791635
Recruitment Status : Recruiting
First Posted : November 14, 2008
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The study investigates whether certain characteristics of gynecological cancer can help researchers predict how well a patient recovers from surgery to remove the lower colon, rectum, and bladder, and create openings through which urine and stool are passed out of the body (pelvic exenteration). Comparing the types of surgery completed and procedures used may help researchers to determine which are most effective and safe in patients with a history of gynecologic cancer.

Condition or disease Intervention/treatment
Cervical Carcinoma Endometrial Carcinoma Malignant Female Reproductive System Neoplasm Vaginal Carcinoma Vulvar Carcinoma Other: Quality-of-Life Assessment Other: Questionnaire Administration

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the types of complications experienced by women who undergo pelvic exenteration at University of Texas (UT) MD Anderson Cancer Center.

II. 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:

I. To evaluate pathologic predictors of recurrence including histology, size of tumor, and distance of closest margin.

II. To longitudinally assess quality of life, sexual functioning, and symptoms in women who have undergone pelvic exenteration for gynecologic malignancies.

III. To assess the impact of certain preoperative factors (albumin, electrolyte levels, body mass index) on the occurrence of post-operative complications.

IV. To determine if preoperative positron emission tomography (PET)/computed tomography (CT) correlates with pathologic findings at the time of surgery.

V. 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.

OUTLINE:

RETROSPECTIVE PORTION: Patients who have undergone pelvic exenteration complete one set of quality of life (QOL) questionnaires.

PROSPECTIVE PORTION: Patients undergoing pelvic exenteration complete questionnaires over 20-40 minutes within 2 weeks before surgery, and at 4-12 weeks, 6 months, and 1, 2, 3, 4, 5, and 10 years after surgery regarding feelings, abilities, depression, coping, social support, sexual function and body image. Patients with cervical cancer may complete 1 additional questionnaire during each of these visits.

Patients who undergo surgery are followed up every 3 months for the first 2 years, and then every 6 months for 3 years.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Evaluation of Women Undergoing Pelvic Exenteration for Treatment of Gynecologic Malignancy
Actual Study Start Date : July 11, 2008
Estimated Primary Completion Date : September 30, 2025
Estimated Study Completion Date : September 30, 2025

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Observational (questionnaires)

RETROSPECTIVE PORTION: Patients who have undergone pelvic exenteration complete one set of QOL questionnaires.

PROSPECTIVE PORTION: Patients undergoing pelvic exenteration complete questionnaires over 20-40 minutes within 2 weeks before surgery, and at 4-12 weeks, 6 months, and 1, 2, 3, 4, 5, and 10 years after surgery regarding feelings, abilities, depression, coping, social support, sexual function and body image. Patients with cervical cancer may complete 1 additional questionnaire during each of these visits.

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Complete questionnaires




Primary Outcome Measures :
  1. Number of surgical complications [ Time Frame: 4 years ]
    Will determine whether the number of surgical complications varies by vaginal and bladder reconstruction type.

  2. Short-term and long-term complications [ Time Frame: 4 years ]
    Will calculate incidence with exact 95% confidence intervals, and will calculate summary statistics. Will create the statistics using both cohorts of patients together. Will also do this separately by cohort and by vaginal reconstruction type as well as by bladder reconstruction type. A Wilcoxon rank-sum test will be used to determine whether there is a difference in number of complications by vaginal reconstruction type and by bladder reconstruction type. This will be conducted separately for each cohort. Finally, will create a Poisson regression model using both cohorts of patients with terms for cohort, vaginal reconstruction type and bladder reconstruction type as well as certain preoperative factors (albumin, electrolyte levels, body mass index) that might be predictive of number of complications.

  3. Quality of life [ Time Frame: Up to 5 years ]
    Will summarize composite scores of the quality of life surveys by time from exenteration. This will be done separately for the retrospectively recruited patients and the prospectively recruited patients. Will also summarize information by year of surgery. To determine how quality of life changes over time, will create longitudinal models for each survey instrument given to the women. The two cohorts of women will initially be analyzed separately. A second model will be created using all patients that has terms for cohort, vaginal reconstruction type and bladder reconstruction type to determine whether these terms have an effect upon quality of life.

  4. Recurrence [ Time Frame: Up to 5 years ]
    Will calculate median time to recurrence in patients who undergo pelvic exenteration. Will use log-rank tests and construct proportional hazards models to evaluate pathologic predictors of recurrence such as histology, size of tumor, and distance of closest margin.

  5. Overall survival [ Time Frame: Up to 5 years ]
    Will calculate overall survival of patients who undergo pelvic exenteration. Will use log-rank tests and construct proportional hazards models to evaluate pathologic predictors of survival such as histology, size of tumor, and distance of closest margin.

  6. Disease-free survival [ Time Frame: Up to 5 years ]
    Will calculate disease-free survival of patients who undergo pelvic exenteration. Will use log-rank tests and construct proportional hazards models to evaluate pathologic predictors of survival such as histology, size of tumor, and distance of closest margin.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with a history of gynecologic malignancy who have undergone or are being offered a pelvic exenteration
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 for 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00791635


Contacts
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Contact: Pamela Soliman 713-745-2352 psoliman@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Pamela T. Soliman    713-745-2352      
Principal Investigator: Pamela T. Soliman         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Pamela T Soliman M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00791635    
Other Study ID Numbers: 2008-0095
NCI-2020-07746 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2008-0095 ( Other Identifier: M D Anderson Cancer Center )
First Posted: November 14, 2008    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Carcinoma
Endometrial Neoplasms
Genital Neoplasms, Female
Vulvar Neoplasms
Vaginal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Vulvar Diseases
Vaginal Diseases