Clinical trial NCT00791635: Longitudinal Evaluation of Women Undergoing Pelvic Surgery for the Treatment of Gynecologic Cancer
Official title: Longitudinal Evaluation of Women Undergoing Pelvic Exenteration for Treatment of Gynecologic Malignancy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cervical Carcinoma
Endometrial Carcinoma
Malignant Female Reproductive System Neoplasm
Vaginal Carcinoma
Vulvar Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2008-11-14
Enrollment: 79
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with a history of gynecologic malignancy who have undergone or are being offered a pelvic exenteration

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of surgical complications
timeFrame: 4 years
measure: Short-term and long-term complications
timeFrame: 4 years
measure: Quality of life
timeFrame: Up to 5 years
measure: Recurrence
timeFrame: Up to 5 years
measure: Overall survival
timeFrame: Up to 5 years
measure: Disease-free survival
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Pamela T Soliman
role: PRINCIPAL_INVESTIGATOR
References: