MDACC Study Summary 2008-0095

Study Summary
No. 2008-0095:.......Cervix; Endometrial; Vagina; Vulva......Pamela Soliman......Gynecologic Oncology

Study Summary Title



Study Summary Number:	2008-0095

Study Title:	Longitudinal Evaluation of Women Undergoing Pelvic Exenteration for Treatment of Gynecologic Malignancy

Physician

New Patient Referral



Name:	Pamela Soliman	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Gynecologic Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-2352 Contact us about clinical trials

General Information



Disease Group:	Cervix Endometrial Vagina Vulva	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	n/a

Treatment Agents:	Questionnaire	Home Care:	n/a

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	n/a


Description/ Intervention:	The goal of this study is to learn if certain characteristics of gynecological cancer can help researchers predict how well a patient recovers from pelvic exenteration surgery. Researchers will compare the types of surgery completed and procedures used to find out which are most effective and safe. Researchers will also study how this surgery affects your quality of life.

Study Objectives / Outcomes

Primary Objectives

1. To determine the types of complications experienced by women who undergo pelvic exenteration at UT MD Anderson Cancer Center.

2. 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

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

2. 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.

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

4. To determine if preoperative PET/CT correlates with pathologic findings at the time of surgery.

5. 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.

Study Status Information



Study Activation / Registration Date:	07/11/2008

IRB Review and Approval Date:	07/11/2008

Study Type:	Behavioral

Recruitment Status:	Open

Projected Accrual:	200

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Women with a history of gynecologic malignancy, including cervical, endometrial, vulvar, or vaginal carcinoma of any histology.

2) Women who have undergone a pelvic exenteration after January 1993 or who are being offered a pelvic exenteration for treatment of their gynecologic malignancy.

3) Patients must be suitable candidates fo surgery (in case of prospective collection).

4) Patients who have signed an approved Informed Consent.

5) Patients with a prior malignancy allowed if > 3 years previous with no current evidence of disease.

6) Females older than 18 years.

7) Women must be able to read and write in either Spanish or English.

Exclusion Criteria:

1) Patients with contraindications to surgery.

2) Patients unwilling or unable to complete self-administered questionnaires.

3) Patients who do not read or speak English or Spanish.

Links

Registration Number: NCT00791635
Study Information on Clinical Trials Registry (clinicaltrials.gov)