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

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Endometrial Carcinoma; Malignant Female Reproductive System Neoplasm; Vulvar Carcinoma; Vaginal Carcinoma; Cervical Carcinoma

Treatments: Other: Questionnaire Administration; Other: Quality-of-Life Assessment

Study type: Observational

Funder types: Other

Identifiers

NCT00791635

2008-0095 (Other Identifier)

NCI-2020-07746 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 79 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

79 participants in 1 patient group

Observational (questionnaires)

Description:

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.

Treatment:

Other: Quality-of-Life Assessment

Other: Questionnaire Administration