Longitudinal Evaluation of Women Undergoing Pelvic Exenteration for Treatment of Gynecologic Malignancy

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Brief Title

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

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.
    


Study Type

Observational


Primary Outcome

Number of surgical complications


Condition

Cervical Carcinoma

Intervention

Quality-of-Life Assessment

Study Arms / Comparison Groups

 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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

200

Start Date

July 11, 2008

Completion Date

September 30, 2025

Primary Completion Date

September 30, 2025

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
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Pamela T Soliman, 713-745-2352, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00791635

Organization ID

2008-0095

Secondary IDs

NCI-2020-07746

Responsible Party

Sponsor

Study Sponsor

M.D. Anderson Cancer Center


Study Sponsor

Pamela T Soliman, Principal Investigator, M.D. Anderson Cancer Center


Verification Date

March 2021